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A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)

Sponsor
Astellas Pharma Global Development, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03192176
Collaborator
(none)
356
Enrollment
51
Locations
8
Arms
14
Actual Duration (Months)
7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This was a 12-week randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multi-center study to assess the efficacy of ESN364 in postmenopausal women suffering from vasomotor symptoms (hot flashes).

This study consisted of a screening period (Days -35 to -1, including the screening visit [Visit 1] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity assessments), a 12 week treatment period (Day 1 [Visit 2] to Week 12 [Visit 5]), and a follow up visit (Week 15 [Visit 6]) 3 weeks after the last dose of study drug.

The study was performed on an ambulatory basis. The screening visit (Visit 1) occurred up to 35 days prior to randomization. Eligibility was assessed via physical examination, clinical laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy. Subjects received an electronic diary to record daily vasomotor symptoms during the duration of the screening period. Subjects who had ≥7 consecutive days of vasomotor symptom recordings participated in the study. Subjects are encouraged to continue recording for the duration of the whole screening period. The electronic diary was reviewed by study site staff on Day 1 (Visit 2) to confirm study eligibility. Subjects were rescreened 1 time upon approval of the medical monitor.

During the treatment period, subjects returned to the study site every 4 weeks for assessments.

The follow-up visit occurred approximately 3 weeks following the last dose of study drug.

Study Design

Study Type:
Interventional
Actual Enrollment :
356 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)
Actual Study Start Date :
Jul 19, 2017
Actual Primary Completion Date :
Sep 19, 2018
Actual Study Completion Date :
Sep 19, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.

Drug: Fezolinetant
Oral Capsule
Other Names:
  • ESN364

    		•
    Experimental: Fezolinetant 15 mg

    Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.

    Drug: Placebo
    Oral Capsule
    Experimental: Fezolinetant 30 mg

    Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.

    Drug: Fezolinetant
    Oral Capsule
    Other Names:
  • ESN364

    		•
    Experimental: Fezolinetant 60 mg

    Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.

    Drug: Fezolinetant
    Oral Capsule
    Other Names:
  • ESN364

    		•
    Experimental: Fezolinetant 90 mg

    Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.

    Drug: Fezolinetant
    Oral Capsule
    Other Names:
  • ESN364

    		•
    Experimental: Fezolinetant 30 mg + Placebo

    Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.

    Drug: Fezolinetant
    Oral Capsule
    Other Names:
  • ESN364

    		•
    Experimental: Fezolinetant 60 mg + Placebo

    Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.

    Drug: Fezolinetant
    Oral Capsule
    Other Names:
  • ESN364

    		•
    Experimental: Fezolinetant 120 mg + Placebo

    Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.

    Drug: Fezolinetant
    Oral Capsule
    Other Names:
  • ESN364

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 [Baseline and week 4]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    2. Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 [Baseline and week 12]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    3. Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 [Baseline and week 4]

      Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.

    4. Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 [Baseline and week 12]

      Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity.

    Secondary Outcome Measures

    1. Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week [Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    2. Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week [Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    3. Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week [Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      Severity of mild, moderate & severe VMS per day was calculated as follows [(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily mild/moderate/severe VMS Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot & was sweating & needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.

    4. Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week [Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15]

      Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity.

    5. Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week [Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: (number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3). Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity.

    6. Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week [Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The hot flash score per 24h of moderate and severe VMS is calculated as follows: (number of moderate VMS x 2) + (number of severe VMS x 3). Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity.

    7. Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week [Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    8. Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week [Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    9. Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    10. Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    11. Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    12. Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    13. Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    14. Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    15. Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    16. Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    17. Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    18. Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    19. Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    20. Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    21. Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    22. Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    23. Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    24. Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week [Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15]

      The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

    25. Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15 [Baseline and weeks 4, 8, 12, and 15]

      The HFRDIS is a 10-item scale that measures a woman's perceptions of the degree to which VMS interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, and enjoying life); the tenth item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory, which assess the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which VMS had interfered with each item during the previous 2-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score is the average of individual item scores (sum of items/10).

    26. Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15 [Weeks 4, 8, 12, and 15]

      The LSEQ is a 10-item self-rated questionnaire that assesses a participants aspects of sleep and early morning behavior. The questions are grouped into 4 chronological areas: ease of getting to sleep, perceived quality of sleep, ease of awaking from sleep, and integrity of early morning behavior following wakefulness. The LSEQ is a visual analog scale that requires respondents to place marks on a group of 10 cm lines. Lines extend between extremes like "more difficult than usual" and "easier than usual." Responses are measured using a 100 mm scale and are averaged to a score for each domain. Higher scores indicates better sleep and better early morning behavior.

    27. Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15 [Baseline and weeks 4, 8, 12, and 15]

      The GCS is a 21-item scale that provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item is rated by the participant according to its severity using a 4-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into 3 main independent symptom measures by summing up the individual item scores: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and VMS (items 19 to 20; score 0 to 6). Item 21 is a probe for sexual dysfunction. The total score can range from 0 to 63. Higher scores indicate worse symptoms.

    28. Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15 [Baseline and weeks 4, 8, 12, and 15]

      The MENQoL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of 1 of 4 domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1 to 8. Higher scores indicate that menopause symptoms are more bothersome.

    29. Change Over Time From Baseline in Plasma Concentrations of Luteinizing Hormone (LH) at Week 12 [Baseline and week 12]

      Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.

    30. Change Over Time From Baseline in Plasma Concentrations of Follicle-Stimulating Hormone (FSH) at Week 12 [Baseline and week 12]

      Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.

    31. Change Over Time From Baseline in Plasma Concentrations of Estradiol (E2) at Week 12 [Baseline and week 12]

      Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. The analysis value for Estradiol was imputed as 73.4/2 = 36.7 when result was < 73.4.

    32. Change Over Time From Baseline in Plasma Concentrations of Sex Hormone-Binding Globulin (SHBG) at Week 12 [Baseline and week 12]

      Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women >40 years and ≤65 years of age at the screening visit;

    • A body mass index between 18 kg/sqm to 38 kg/sqm (extremes included);

    • Spontaneous amenorrhea for ≥12 consecutive months; or spontaneous amenorrhea for ≥6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] >40 IU/L); or having had bilateral oophorectomy ≥6 weeks prior to the screening visit (with or without hysterectomy);

    • At least 50 moderate to severe vasomotor symptoms per week (ie, 7 consecutive days), as recorded in the daily diary during the screening period;

    • In good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations, as judged by the Investigator;

    • Women >40 years of age who have documentation of a normal/negative or no clinically significant findings mammogram (obtained at Screening or within the prior 9 months of trial enrollment.) Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings;

    • Willing to undergo a transvaginal ultrasound to assess endometrial thickness at Screening and at Week 12 (end-of-treatment, - and subjects) who are withdrawn from the study prior to completion, at the Early Termination (ET) Visit. This is not required for subjects who have had a partial (supracervical) or full hysterectomy;

    • Willing to undergo an endometrial biopsy at Screening (in the event that the subject's transvaginal ultrasound shows endometrial thickness ≥4 mm) and at Week 12 (end--of--treatment) - all subjects), for subjects with uterine bleeding, and for subjects who are withdrawn from the study prior to completion, at the ET Visit if study drug exposure is ≥10 weeks. This is not required for subjects who have had a partial (supracervical) or full hysterectomy;

    • Negative alcohol breath test and negative urine test for selected drugs of abuse (amphetamines, tricyclic antidepressants, cocaine, or opiates) at the screening visit;

    • Negative urine pregnancy test;

    • Negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody screens);

    • Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; and

    • Documentation of a normal Pap smear (or equivalent cervical cytology) or of no clinical significance in the opinion of the Investigator within the previous 9 months or at Screening.

    Exclusion Criteria:

    • Use of a prohibited therapy (hormone therapy, hormonal contraceptive, or vasomotor symptom medication [prescription, over the counter, or herbal]) or not willing to wash out drugs

    • History (in the past year) or presence of drug or alcohol abuse;

    • Previous or current history of a malignant tumor, except for basal cell carcinoma;

    • Uncontrolled hypertension and a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg;

    • Judged by the Investigator to be unsuited to participate in the study based on findings observed during physical examination, vital sign assessment, or 12-lead electrocardiogram (ECG);

    • History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients;

    • Exclusion criterion 7 has been removed in Amendment 1;

    • An unacceptable result from endometrial biopsy (performed when endometrial thickness is ≥ 4mm measured by transvaginal ultrasound) of endometrial hyperplasia, endometrial cancer, or inadequate specimen at Screening (1 repeat biopsy permitted if technically possible);

    • History of endometrial hyperplasia or uterine/endometrial cancer;

    • History of unexplained uterine bleeding;

    • History of seizures or other convulsive disorders;

    • Medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [eg, moderate asthma], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome;

    • Presence or sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion (ADME) mechanisms of drugs as judged by the Investigator;

    • Active liver disease or jaundice, or values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 x the upper limit of normal (ULN); or total bilirubin >1.5 x ULN; or creatinine >1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula ≤59 mL/min/1.73 sqm at the screening visit;

    • Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study);

    • Suicide attempt in the past 3 years;

    • Unable or unwilling to complete the study procedures; or

    • Subject is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof, who is directly involved in the conduct of the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Anniston Alabama United States 36207
    2 Research Site Birmingham Alabama United States 35205
    3 Research Site Phoenix Arizona United States 85023
    4 Research Site Los Angeles California United States 90057
    5 Research Site Oceanside California United States 92056
    6 Research Site Panorama City California United States 91402
    7 Research Site 052 Sacramento California United States 95821
    8 Research Site 058 Sacramento California United States 95821
    9 Research Site San Diego California United States 92114
    10 Research Site Thousand Oaks California United States 91360
    11 Research Site Valley Village California United States 91607
    12 Research Site Denver Colorado United States 80209
    13 Research Site Milford Connecticut United States 06460
    14 Research Site Crystal River Florida United States 34429
    15 Research Site DeLand Florida United States 32720
    16 Research Site Jupiter Florida United States 33458
    17 Research Site Lake Worth Florida United States 33461
    18 Research Site Miami Florida United States 33144
    19 Research Site Ormond Beach Florida United States 32174
    20 Research Site Port Saint Lucie Florida United States 34952
    21 Research Site Atlanta Georgia United States 30312
    22 Research Site Norcross Georgia United States 30092
    23 Research Site Meridian Idaho United States 83642
    24 Research Site Champaign Illinois United States 61820
    25 Research Site Marrero Louisiana United States 70072
    26 Research Site Elkridge Maryland United States 21075
    27 Research Site Watertown Massachusetts United States 02472
    28 Research Site Lincoln Nebraska United States 68510
    29 Research Site Norfolk Nebraska United States 68701
    30 Research Site Las Vegas Nevada United States 89123
    31 Research Site New York New York United States 10032
    32 Research Site Williamsville New York United States 14221
    33 Research Site Cincinnati Ohio United States 45267
    34 Research Site Cleveland Ohio United States 44122
    35 Research Site Columbus Ohio United States 43210
    36 Research Site Columbus Ohio United States 43213
    37 Research Site Oklahoma City Oklahoma United States 73112
    38 Research Site Philadelphia Pennsylvania United States 19140
    39 Research Site Mount Pleasant South Carolina United States 29464
    40 Research Site Clarksville Tennessee United States 37040
    41 Research Site Kingsport Tennessee United States 37660
    42 Research Site Houston Texas United States 77058
    43 Research Site Hurst Texas United States 76054
    44 Research Site Lampasas Texas United States 76550
    45 Research Site Plano Texas United States 75093
    46 Research Site San Antonio Texas United States 78229
    47 Research Site Riverton Utah United States 84065
    48 Research Site Charlottesville Virginia United States 22911
    49 Research Site Vienna Virginia United States 22182
    50 Research Site Seattle Washington United States 98105
    51 Research Site Spokane Washington United States 99207

    Sponsors and Collaborators

    • Astellas Pharma Global Development, Inc.

    Investigators

    • Study Director: Medical Director, Astellas Pharma Global Development, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT03192176
    Other Study ID Numbers:
    • ESN364_HF_205
    First Posted:
    Jun 19, 2017
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Astellas Pharma Global Development, Inc.
    Vasomotor symptoms
    Menopause
    Hot flashes
    Perimenopause
    Additional relevant MeSH terms:
    Hot Flashes

    Study Results

    Participant Flow

    Recruitment Details Postmenopausal women participants 40 to 65 years of age who had at least 50 moderate to severe vasomotor symptoms (VMS) per week and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study.
    Pre-assignment Detail Prior to randomization, participants had a screening period during which a minimum 7-day collection of baseline VMS frequency and severity assessments were performed.
    Arm/Group Title Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, once daily (QD) and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Period Title: Overall Study
    STARTED 44 45 44 45 44 45 45 44
    Treated 43 45 43 45 44 43 45 44
    COMPLETED 37 40 38 33 32 34 36 37
    NOT COMPLETED 7 5 6 12 12 11 9 7

    Baseline Characteristics

    Arm/Group Title Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD Total
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Total of all reporting groups
    Overall Participants 43 45 43 45 44 43 45 44 352
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.8
    (5.5)
    53.7
    (5.0)
    53.9
    (3.8)
    54.6
    (5.0)
    54.9
    (4.0)
    52.7
    (3.8)
    55.0
    (4.9)
    56.8
    (4.4)
    54.6
    (4.7)
    Sex: Female, Male (Count of Participants)
    Female
    43
    100%
    45
    100%
    43
    100%
    45
    100%
    44
    100%
    43
    100%
    45
    100%
    44
    100%
    352
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    15
    34.9%
    16
    35.6%
    9
    20.9%
    13
    28.9%
    10
    22.7%
    17
    39.5%
    12
    26.7%
    9
    20.5%
    101
    28.7%
    Not Hispanic or Latino
    28
    65.1%
    29
    64.4%
    34
    79.1%
    32
    71.1%
    34
    77.3%
    26
    60.5%
    33
    73.3%
    35
    79.5%
    251
    71.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    2.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.3%
    0
    0%
    0
    0%
    2
    0.6%
    Asian
    2
    4.7%
    0
    0%
    0
    0%
    1
    2.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    0.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    10
    23.3%
    8
    17.8%
    12
    27.9%
    15
    33.3%
    8
    18.2%
    11
    25.6%
    10
    22.2%
    13
    29.5%
    87
    24.7%
    White
    30
    69.8%
    37
    82.2%
    31
    72.1%
    28
    62.2%
    36
    81.8%
    31
    72.1%
    34
    75.6%
    30
    68.2%
    257
    73%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    1
    2.2%
    0
    0%
    0
    0%
    1
    2.2%
    1
    2.3%
    3
    0.9%
    Frequency of Moderate and Severe Vasomotor Symptoms per 24h (VMS per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [VMS per day]
    9.71
    (3.53)
    11.12
    (7.13)
    9.85
    (4.62)
    9.48
    (3.97)
    9.32
    (3.59)
    11.18
    (6.44)
    9.42
    (2.70)
    9.65
    (3.73)
    9.97
    (4.71)
    Severity of Moderate and Severe Vasomotor Symptoms per 24h (Score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score on a scale]
    2.46
    (0.31)
    2.45
    (0.27)
    2.43
    (0.31)
    2.45
    (0.31)
    2.38
    (0.30)
    2.43
    (0.30)
    2.40
    (0.26)
    2.49
    (0.32)
    2.44
    (0.30)
    Frequency of Mild, Moderate, and Severe Vasomotor Symptoms per 24h (VMS per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [VMS per day]
    9.96
    (3.49)
    11.63
    (7.10)
    10.33
    (4.88)
    10.14
    (4.22)
    9.85
    (4.31)
    11.72
    (6.66)
    10.15
    (2.86)
    10.15
    (3.78)
    10.5
    (4.88)
    Severity of Mild, Moderate, and Severe Vasomotor Symptoms per 24h (Score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score on a scale]
    2.43
    (0.32)
    2.38
    (0.29)
    2.37
    (0.33)
    2.38
    (0.36)
    2.33
    (0.33)
    2.38
    (0.34)
    2.31
    (0.31)
    2.43
    (0.37)
    2.38
    (0.33)

    Outcome Measures

    1. Primary Outcome
    Title Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Baseline and week 4

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 40 41 40 37 40 43 42
    Least Squares Mean (Standard Error) [VMS per day]
    -4.2
    (0.65)
    -6.1
    (0.65)
    -7.2
    (0.64)
    -7.0
    (0.62)
    -7.7
    (0.65)
    -6.5
    (0.65)
    -7.2
    (0.61)
    -6.6
    (0.63)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0240
    Comments LS Means(LSM), standard errors(SE), confidence intervals(CI), & p-values come from an ANCOVA model with CFB as the dependent variable & treatment group, pooled center, smoking status as factors & baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.56 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.68 to -1.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.44 to -1.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -5.20 to -1.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval () 95%
    -4.00 to -0.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.65 to -1.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -4.06 to 0.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    2. Primary Outcome
    Title Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Baseline and week 12

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 37 38 37 31 31 33 36 36
    Least Squares Mean (Standard Error) [VMS per day]
    -5.3
    (0.58)
    -7.2
    (0.54)
    -7.5
    (0.56)
    -7.6
    (0.55)
    -8.0
    (0.58)
    -7.4
    (0.58)
    -7.9
    (0.54)
    -7.4
    (0.57)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0154
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.30 to -0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.60 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.74
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.76 to -0.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.09 to -1.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.52 to -0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter -2.6
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.04 to -1.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.74
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.52 to -0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    3. Primary Outcome
    Title Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4
    Description Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.
    Time Frame Baseline and week 4

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 40 41 40 37 40 43 42
    Least Squares Mean (Standard Error) [Score on a scale]
    -0.3
    (0.15)
    -0.8
    (0.14)
    -0.9
    (0.15)
    -1.2
    (0.14)
    -1.3
    (0.15)
    -0.7
    (0.15)
    -0.9
    (0.14)
    -1.0
    (0.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0215
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.01 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.21 to -0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.37 to -0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0322
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.81 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.08 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    4. Primary Outcome
    Title Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12
    Description Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity.
    Time Frame Baseline and week 12

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 37 38 37 31 31 33 36 36
    Least Squares Mean (Standard Error) [Score on a scale]
    -0.8
    (0.16)
    -1.0
    (0.15)
    -1.1
    (0.16)
    -1.3
    (0.16)
    -1.4
    (0.17)
    -0.9
    (0.16)
    -1.3
    (0.15)
    -1.1
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2324
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.67 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0736
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0080
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.98 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.07 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4647
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean differnce
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.58 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0160
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.92 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0901
    Comments LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.78 to 0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    -2.0
    (0.60)
    -3.4
    (0.56)
    -4.7
    (0.59)
    -5.5
    (0.58)
    -6.1
    (0.61)
    -3.0
    (0.61)
    -4.4
    (0.56)
    -4.8
    (0.59)
    Week 2
    -3.6
    (0.62)
    -4.9
    (0.58)
    -6.3
    (0.61)
    -6.8
    (0.60)
    -7.3
    (0.63)
    -5.1
    (0.63)
    -5.4
    (0.59)
    -6.0
    (0.61)
    Week 3
    -3.8
    (0.63)
    -5.6
    (0.60)
    -6.8
    (0.62)
    -7.3
    (0.61)
    7.7
    (0.64)
    -5.8
    (0.64)
    -6.1
    (0.60)
    -6.6
    (0.62)
    Week 4
    -4.0
    (0.63)
    -5.7
    (0.60)
    -7.0
    (0.62)
    -7.2
    (0.61)
    -8.1
    (0.64)
    -6.0
    (0.64)
    -6.8
    (0.60)
    -7.1
    (0.62)
    Week 5
    -4.6
    (0.60)
    -5.8
    (0.57)
    -7.2
    (0.59)
    -7.6
    (0.58)
    -8.5
    (0.61)
    -6.6
    (0.61)
    -6.8
    (0.56)
    -7.1
    (0.59)
    Week 6
    -4.9
    (0.60)
    -6.2
    (0.57)
    -7.2
    (0.59)
    -8.0
    (0.58)
    -8.6
    (0.62)
    -6.6
    (0.61)
    -7.1
    (0.57)
    -7.6
    (0.59)
    Week 7
    -4.9
    (0.61)
    -6.2
    (0.58)
    -7.4
    (0.60)
    -7.8
    (0.59)
    -8.7
    (0.63)
    -6.8
    (0.62)
    -7.2
    (0.58)
    -7.7
    (0.60)
    Week 8
    -5.5
    (0.61)
    -6.2
    (0.58)
    -7.5
    (0.60)
    -8.1
    (0.60)
    -8.5
    (0.63)
    -6.8
    (0.63)
    -7.4
    (0.58)
    -7.8
    (0.61)
    Week 9
    -5.8
    (0.59)
    -6.8
    (0.55)
    -7.5
    (0.57)
    -8.3
    (0.57)
    -8.7
    (0.60)
    -6.8
    (0.60)
    -7.7
    (0.56)
    -7.9
    (0.58)
    Week 10
    -5.6
    (0.60)
    -7.0
    (0.57)
    -7.1
    (0.59)
    -8.3
    (0.59)
    -8.7
    (0.62)
    -7.2
    (0.62)
    -7.8
    (0.58)
    -8.0
    (0.60)
    Week 11
    -5.7
    (0.59)
    -7.0
    (0.56)
    -7.5
    (0.58)
    -8.7
    (0.58)
    -8.6
    (0.61)
    -7.3
    (0.60)
    -8.0
    (0.56)
    -8.0
    (0.59)
    Week 12
    -5.7
    (0.58)
    -7.1
    (0.54)
    -7.6
    (0.57)
    -8.5
    (0.57)
    -8.8
    (0.59)
    -7.4
    (0.59)
    -8.0
    (0.55)
    -8.1
    (0.57)
    Week 13
    -4.7
    (0.65)
    -5.9
    (0.58)
    -5.1
    (0.60)
    -4.9
    (0.63)
    -5.7
    (0.64)
    -6.1
    (0.65)
    -5.9
    (0.62)
    -5.5
    (0.61)
    Week 14
    -4.4
    (0.65)
    -5.2
    (0.58)
    -4.5
    (0.60)
    -4.5
    (0.63)
    -5.0
    (0.64)
    -5.6
    (0.65)
    -5.7
    (0.63)
    -5.1
    (0.61)
    Week 15
    -4.9
    (0.62)
    -4.5
    (0.56)
    -4.7
    (0.58)
    -4.2
    (0.62)
    -4.5
    (0.62)
    -4.6
    (0.64)
    -5.6
    (0.61)
    -4.7
    (0.59)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0865
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments MMRM: Mixed Model Repeated Measures
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.92 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.22 to -1.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -5.06 to -1.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -5.63 to -2.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2360
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.55 to 0.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.92 to -0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: -2.4
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.29 to -1.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1318
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.86 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.30 to -1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -3.2
    Confidence Interval (2-Sided) 95%
    -4.82 to -1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.6
    Confidence Interval (2-Sided) 95%
    -5.30 to -2.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0752
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -3.15 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0343
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.38 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.95 to -0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0285
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.50 to -0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.69 to -1.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -5.14 to -1.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRm
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -5.65 to -2.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.86
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0169
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.74 to -0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.86
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -4.04 to -0.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.48 to -1.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0428
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.36 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.65 to -1.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.00001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.2
    Confidence Interval (2-Sided) 95%
    -4.88 to -1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: -0.84
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.1
    Confidence Interval (2-Sided) 95%
    -5.73 to -2.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0225
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.64 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.49 to -1.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.70 to -1.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1168
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.80 to 0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.15 to -1.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.54 to -1.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.9
    Confidence Interval (2-Sided) 95%
    -5.44 to -2.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0134
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.58 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0057
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.76 to -0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -4.06 to -0.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0843
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.94 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.90 to -0.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.66 to -1.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -5.28 to -2.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0315
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.33 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.75 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.25 to -1.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1090
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.89 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -4.14 to -0.95
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -4.54 to -1.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.8
    Confidence Interval (2-Sided) 95%
    -5.40 to -2.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0231
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.50 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0056
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.86 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.35 to -1.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3568
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -2.35 to 0.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0129
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.65 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.19 to -0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.70 to -1.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -3.00 to 0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0173
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.57 to -0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0038
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.97 to -0.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1767
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.57 to 0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0308
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.20 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -4.07 to -1.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -4.47 to -1.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2109
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.55 to 0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0152
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.44 to -0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.61 to -0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0869
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.96 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0520
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.14 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.30 to -1.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.68 to -1.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0456
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.25 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0073
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.76 to -0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -4.01 to -0.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0878
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.87 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0182
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.39 to -0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.55 to -1.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.53 to -1.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0387
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.22 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.89 to -0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.88 to -0.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0653
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.90 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0102
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.46 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -4.38 to -1.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.2
    Confidence Interval (2-Sided) 95%
    -4.72 to -1.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0231
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.30 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.88 to -0.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.88 to -0.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -3.96 to -0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1460
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.89 to 0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6066
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -2.10 to 1.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8422
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.88 to 1.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2346
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.74 to 0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1128
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -3.11 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1811
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.89 to 0.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3521
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -2.45 to 0.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3570
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -2.44 to 0.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9227
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.73 to 1.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8894
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.84 to 1.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5074
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -2.29 to 1.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1753
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.91 to 0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1212
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -3.09 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.88
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3702
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -2.41 to 0.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6459
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -1.22 to 1.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8248
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -1.40 to 1.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4226
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -0.98 to 2.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6469
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -1.25 to 2.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7642
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -1.41 to 1.91
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4068
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -2.36 to 0.966
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 106
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7974
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -1.37 to 1.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    -2.1
    (0.59)
    -3.8
    (0.56)
    -5.3
    (0.58)
    -5.7
    (0.57)
    -6.4
    (0.60)
    -3.3
    (0.60)
    -4.7
    (0.56)
    -4.7
    (0.58)
    Week 2
    -3.7
    (0.60)
    -5.3
    (0.57)
    -6.8
    (0.59)
    -6.8
    (0.58)
    -7.3
    (0.61)
    -5.4
    (0.61)
    -6.0
    (0.57)
    -5.7
    (0.59)
    Week 3
    -3.7
    (0.61)
    -5.8
    (0.58)
    -7.3
    (0.60)
    -7.0
    (0.59)
    -7.7
    (0.62)
    -6.3
    (0.62)
    -6.9
    (0.58)
    -6.3
    (0.60)
    Week 5
    -4.5
    (0.58)
    -6.3
    (0.55)
    -7.6
    (0.57)
    -7.3
    (0.56)
    -8.3
    (0.59)
    -6.9
    (0.59)
    -7.3
    (0.55)
    -6.7
    (0.57)
    Week 6
    -4.8
    (0.58)
    -6.6
    (0.55)
    -7.5
    (0.57)
    -7.6
    (0.57)
    -8.3
    (0.60)
    -7.0
    (0.60)
    -7.5
    (0.55)
    -7.1
    (0.58)
    Week 7
    -4.9
    (0.59)
    -6.5
    (0.56)
    -7.7
    (0.58)
    -7.5
    (0.58)
    -8.4
    (0.61)
    -7.1
    (0.60)
    -7.4
    (0.56)
    -7.2
    (0.59)
    Week 8
    -5.5
    (0.59)
    -6.6
    (0.56)
    -7.6
    (0.58)
    -7.7
    (0.58)
    -8.3
    (0.61)
    -7.1
    (0.61)
    -7.7
    (0.56)
    -7.3
    (0.59)
    Week 9
    -5.7
    (0.57)
    -7.1
    (0.54)
    -7.7
    (0.56)
    -8.0
    (0.56)
    -8.4
    (0.59)
    -7.1
    (0.59)
    -7.9
    (0.54)
    -7.3
    (0.57)
    Week 10
    -5.4
    (0.59)
    -7.2
    (0.56)
    -7.5
    (0.58)
    -7.9
    (0.58)
    -8.3
    (0.61)
    -7.4
    (0.60)
    -7.8
    (0.56)
    -7.6
    (0.59)
    Week 11
    -5.5
    (0.57)
    -7.3
    (0.54)
    -7.8
    (0.56)
    -8.3
    (0.56)
    -8.3
    (0.59)
    -7.6
    (0.58)
    -8.0
    (0.54)
    -7.6
    (0.57)
    Week 13
    -4.4
    (0.65)
    -6.4
    (0.58)
    -5.4
    (0.60)
    -5.3
    (0.63)
    -5.7
    (0.64)
    -6.8
    (0.65)
    -6.0
    (0.62)
    -5.2
    (0.61)
    Week 14
    -4.1
    (0.66)
    -5.7
    (0.60)
    -4.5
    (0.61)
    -4.8
    (0.65)
    -5.0
    (0.66)
    -6.2
    (0.67)
    -5.8
    (0.65)
    -4.8
    (0.63)
    Week 15
    -4.6
    (0.65)
    -5.1
    (0.59)
    -4.5
    (0.60)
    -4.5
    (0.65)
    -4.4
    (0.65)
    -5.6
    (0.67)
    -5.5
    (0.65)
    -4.4
    (0.61)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0297
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.23 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.66 to -1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.6
    Confidence Interval (2-Sided) 95%
    -5.10 to -2.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -5.78 to -2.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1318
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.76 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.13 to -1.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.10 to -1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0405
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.20 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.70 to -1.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.66 to -1.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -5.26 to -2.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0325
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.34 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.92 to -0.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0102
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.61 to -0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0098
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.69 to -0.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.6
    Confidence Interval (2-Sided) 95%
    -5.18 to -1.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.3
    Confidence Interval (2-Sided) 95%
    -4.89 to -1.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -5.61 to -2.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.17 to -0.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.71 to -1.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -4.11 to -0.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0210
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.27 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.59 to -1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.88
    Confidence Interval (2-Sided) 95%
    -4.34 to -1.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.8
    Confidence Interval (2-Sided) 95%
    -5.29 to -2.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.73
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.91 to -0.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.25 to -1.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0036
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.73 to -0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0195
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.33 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.21 to -1.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.32 to -1.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -5.01 to -1.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.71 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.19 to -1.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0030
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.81 to -0.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0383
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.17 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.33 to -1.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.14 to -1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -5.07 to -1.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0055
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.80 to -0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -4.09 to -0.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.80 to -0.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1502
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.68 to 0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0057
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.74 to -0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.76 to -0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.38 to -1.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0412
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.21 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.76 to -0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0167
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.43 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0533
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.94 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0065
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.54 to -0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.80 to -0.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -4.22 to -1.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0541
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.99 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0039
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.69 to -0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0245
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.18 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0187
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.36 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.68 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -4.06 to -0.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -4.49 to -1.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0100
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.61 to -0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.98 to -0.91
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.73 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0186
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.25 to -0.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0024
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -3.77 to -0.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.28 to -1.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.30 to -1.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.63 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -4.04 to -1.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0050
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.59 to -0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0205
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.63 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2818
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.58 to 0.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3102
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.60 to 0.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1422
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.99 to 0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -4.12 to -0.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0752
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.28 to 0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3632
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -2.43 to 0.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0625
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.32 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6613
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -2.07 to 1.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.86
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4209
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -2.48 to 1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.90
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3288
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.63 to 0.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.89
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0202
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.86 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.90
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0682
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.42 to 0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.90
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3912
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -2.44 to 0.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.86
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4964
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -2.25 to 1.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9830
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.64 to 1.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9715
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.71 to 1.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.89
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8715
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -1.58 to 1.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2233
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.83 to 0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.89
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2882
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.69 to 0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.89
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8643
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval () 95%
    -1.52 to 1.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.84
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
    Description Severity of mild, moderate & severe VMS per day was calculated as follows [(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily mild/moderate/severe VMS Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot & was sweating & needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.
    Time Frame Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    -0.2
    (0.09)
    -0.5
    (0.08)
    -0.5
    (0.09)
    -0.6
    (0.09)
    -0.8
    (0.09)
    -0.2
    (0.09)
    -0.5
    (0.08)
    -0.5
    (0.09)
    Week 2
    -0.2
    (0.11)
    -0.6
    (0.11)
    -0.7
    (0.11)
    -1.0
    (0.11)
    -1.1
    (0.11)
    -0.4
    (0.11)
    -0.7
    (0.11)
    -0.8
    (0.11)
    Week 3
    -0.3
    (0.13)
    -0.8
    (0.12)
    -0.9
    (0.13)
    -1.1
    (0.12)
    -1.2
    (0.13)
    -0.6
    (0.13)
    -0.9
    (0.12)
    -1.0
    (0.13)
    Week 4
    -0.3
    (0.13)
    -0.8
    (0.12)
    -1.0
    (0.13)
    -1.1
    (0.13)
    -1.4
    (0.13)
    -0.8
    (0.13)
    -0.9
    (0.12)
    -1.1
    (0.13)
    Week 5
    -0.5
    (0.13)
    -0.8
    (0.13)
    -1.0
    (0.13)
    -1.3
    (0.13)
    -1.5
    (0.14)
    -0.8
    (0.14)
    -0.9
    (0.13)
    -1.0
    (0.13)
    Week 6
    -0.5
    (0.14)
    -0.9
    (0.13)
    -1.0
    (0.14)
    -1.4
    (0.14)
    -1.6
    (0.14)
    -0.8
    (0.14)
    -1.0
    (0.13)
    -1.2
    (0.14)
    Week 7
    -0.5
    (0.14)
    -0.9
    (0.14)
    -1.1
    (0.14)
    -1.4
    (0.14)
    -1.6
    (0.15)
    -1.0
    (0.14)
    -1.0
    (0.14)
    -1.2
    (0.14)
    Week 8
    -0.7
    (0.15)
    -1.0
    (0.14)
    -1.2
    (0.15)
    -1.5
    (0.15)
    -1.6
    (0.15)
    -0.9
    (0.15)
    -1.1
    (0.15)
    -1.3
    (0.15)
    Week 9
    -0.8
    (0.15)
    -1.1
    (0.14)
    -1.1
    (0.15)
    -1.6
    (0.15)
    -1.6
    (0.15)
    -0.9
    (0.15)
    -1.2
    (0.15)
    -1.3
    (0.15)
    Week 10
    -0.7
    (0.15)
    -1.2
    (0.14)
    -1.1
    (0.15)
    -1.5
    (0.15)
    -1.7
    (0.15)
    -1.0
    (0.15)
    -1.2
    (0.14)
    -1.4
    (0.15)
    Week 11
    -0.7
    (0.15)
    -1.1
    (0.14)
    -1.1
    (0.15)
    -1.6
    (0.15)
    -1.8
    (0.15)
    -1.0
    (0.15)
    -1.2
    (0.15)
    -1.4
    (0.15)
    Week 12
    -0.8
    (0.15)
    -1.2
    (0.15)
    -1.3
    (0.15)
    -1.6
    (0.15)
    -1.6
    (0.16)
    -1.0
    (0.15)
    -1.3
    (0.15)
    -1.3
    (0.15)
    Week 13
    -0.1
    (0.10)
    -0.5
    (0.09)
    -0.3
    (0.09)
    -0.4
    (0.09)
    -0.3
    (0.09)
    -0.5
    (0.10)
    -0.4
    (0.09)
    -0.2
    (0.09)
    Week 14
    -0.1
    (0.10)
    -0.3
    (0.08)
    -0.2
    (0.09)
    -0.3
    (0.09)
    -0.1
    (0.09)
    -0.4
    (0.09)
    -0.3
    (0.09)
    -0.2
    (0.09)
    Week 15
    0.0
    (0.10)
    -0.2
    (0.09)
    -0.2
    (0.09)
    -0.4
    (0.10)
    -0.1
    (0.09)
    -0.5
    (0.10)
    -0.3
    (0.10)
    -0.1
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0104
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.53 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.56 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.71 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.85 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6977
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.28 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0121
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.53 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0086
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.54 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0138
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.66 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.78 to -0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.02 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.19 to -0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2831
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.46 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0051
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.72 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.81 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.15
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.83 to -0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.14 to -0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.27 to -0.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0807
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.66 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.02 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.85 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.14 to -0.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.14 to -0.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0209
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.77 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.93 to -0.24
    Parameter Dispersion Type: Standard Deviation
    Value: 0.18
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.07 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0956
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.67 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0050
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.18 to -0.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.40 to -0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0915
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.69 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0378
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.75 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0053
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0614
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.83 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.92 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.33 to -0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.47 to -0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0967
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.70 to 0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.90 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.13 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0632
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.75 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.00 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.29 to -0.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.48 to -0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0308
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0105
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.03 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1469
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.69 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0315
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.18 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4494
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.56 to 0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0595
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.79 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0065
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.96 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0745
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.77 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0540
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.22 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5317
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.54 to 0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0424
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.83 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0134
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0300
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0605
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.78 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.20 to -0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.38 to -0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1848
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.68 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0321
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.01 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0441
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.81 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0422
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.27 to -0.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.44 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1464
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.71 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0144
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0596
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0360
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.85 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.15 to -0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.23 to -0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3227
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.62 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0220
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0380
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0067
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.60 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1227
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.45 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0208
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.57 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2396
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.41 to 0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.67 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0479
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.53 to -0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4152
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.35 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0262
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.52 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1210
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.43 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0369
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.52 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5855
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.32 to 0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0041
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.62 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0614
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.50 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3391
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.36 to 0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0515
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.49 to 0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0667
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.47 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0047
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.63 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5130
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.34 to 0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.75 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0126
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.60 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3507
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.36 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
    Description Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity.
    Time Frame Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    -0.1
    (0.10)
    -0.4
    (0.09)
    -0.5
    (0.10)
    -0.6
    (0.10)
    -0.8
    (0.10)
    -0.1
    (0.10)
    -0.4
    (0.09)
    -0.4
    (0.10)
    Week 2
    -0.2
    (0.12)
    -0.5
    (0.12)
    -0.7
    (0.12)
    -1.0
    (0.12)
    -1.2
    (0.13)
    -0.3
    (0.13)
    -0.6
    (0.12)
    -0.8
    (0.12)
    Week 3
    -0.2
    (0.14)
    -0.7
    (0.14)
    -1.0
    (0.14)
    -1.2
    (0.14)
    -1.3
    (0.15)
    -0.6
    (0.14)
    -0.8
    (0.14)
    -1.0
    (0.14)
    Week 5
    -0.5
    (0.15)
    -0.8
    (0.14)
    -1.1
    (0.15)
    -1.4
    (0.15)
    -1.6
    (0.15)
    -0.9
    (0.15)
    -0.8
    (0.14)
    -1.1
    (0.15)
    Week 6
    -0.5
    (0.15)
    -0.9
    (0.15)
    -1.1
    (0.15)
    -1.5
    (0.15)
    -1.6
    (0.16)
    -0.9
    (0.15)
    -1.0
    (0.15)
    -1.3
    (0.15)
    Week 7
    -0.5
    (0.15)
    -0.9
    (0.15)
    -1.2
    (0.15)
    -1.5
    (0.15)
    -1.7
    (0.16)
    -1.0
    (0.16)
    -1.0
    (0.15)
    -1.2
    (0.15)
    Week 8
    -0.7
    (0.16)
    -1.0
    (0.15)
    -1.2
    (0.16)
    -1.6
    (0.16)
    -1.6
    (0.17)
    -0.9
    (0.16)
    -1.2
    (0.16)
    -1.3
    (0.16)
    Week 9
    -0.8
    (0.16)
    -1.1
    (0.15)
    -1.2
    (0.16)
    -1.6
    (0.16)
    -1.7
    (0.16)
    -0.9
    (0.16)
    -1.2
    (0.15)
    -1.3
    (0.16)
    Week 10
    -0.8
    (0.16)
    -1.2
    (0.15)
    -1.2
    (0.16)
    -1.7
    (0.16)
    -1.8
    (0.16)
    -1.1
    (0.16)
    -1.2
    (0.15)
    -1.4
    (0.16)
    Week 11
    -0.8
    (0.16)
    -1.1
    (0.15)
    -1.2
    (0.16)
    -1.7
    (0.16)
    -1.8
    (0.16)
    -1.1
    (0.16)
    -1.3
    (0.15)
    -1.5
    (0.16)
    Week 13
    -0.1
    (0.13)
    -0.5
    (0.12)
    -0.3
    (0.12)
    -0.6
    (0.13)
    -0.3
    (0.13)
    -0.6
    (0.13)
    -0.4
    (0.13)
    -0.2
    (0.12)
    Week 14
    -0.1
    (0.13)
    -0.3
    (0.11)
    -0.3
    (0.11)
    -0.5
    (0.12)
    -0.1
    (0.12)
    -0.5
    (0.13)
    -0.3
    (0.13)
    -0.2
    (0.12)
    Week 15
    0.0
    (0.13)
    -0.2
    (0.12)
    -0.3
    (0.12)
    -0.6
    (0.13)
    -0.1
    (0.13)
    -0.5
    (0.13)
    -0.4
    (0.13)
    -0.1
    (0.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0098
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.60 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.63 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.80 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.00 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6761
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.32 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0188
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.57 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0067
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.61 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0335
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.68 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.14 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.41 to -0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3227
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.50 to 0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0085
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.77 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.95 to -0.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0102
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.87 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.15 to -0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.29 to -0.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.46 to -0.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0740
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.73 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0024
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.17 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1197
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.72 to 0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.98 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.28 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.51 to -0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0553
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0823
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.76 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.96 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0374
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.83 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.00 to -0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.38 to -0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.54 to -0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0710
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.79 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0160
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.15 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.76 to 0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.11 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.36 to -0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.57 to -0.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0476
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.85 to -0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0220
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.90 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.07 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1457
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.74 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0284
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.36 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4223
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0442
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.87 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0071
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.02 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0823
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0336
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.32 to -0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.34 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4819
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.59 to 0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0371
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.88 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0121
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0281
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.89 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0436
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.86 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.34 to -0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.47 to -0.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1488
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.75 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0251
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.08 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1053
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.77 to 0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0304
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.90 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.33 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.49 to -0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0873
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.81 to 0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0124
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.12 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0479
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.68 to -0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2342
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.54 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4291
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.49 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0076
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.83 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1506
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.62 to 0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5479
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.44 to 0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1427
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.57 to 0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1498
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.56 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.16
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0103
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.79 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8984
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.36 to 0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0095
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.79 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1370
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.60 to 0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4223
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.46 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3265
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.50 to 0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0852
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.62 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.91 to -0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5717
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.45 to 0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0084
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0277
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.75 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4627
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.46 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
    Description The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: (number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3). Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity.
    Time Frame Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    -5.0
    (1.48)
    -9.8
    (1.39)
    -12.9
    (1.45)
    -14.1
    (1.42)
    -15.5
    (1.50)
    -8.4
    (1.50)
    -11.9
    (1.39)
    -11.9
    (1.45)
    Week 2
    -8.9
    (1.50)
    -13.0
    (1.41)
    -16.5
    (1.47)
    -17.0
    (1.44)
    -18.1
    (1.52)
    -13.5
    (1.52)
    -14.8
    (1.41)
    -14.5
    (1.47)
    Week 3
    -8.9
    (1.54)
    -14.5
    (1.45)
    -17.6
    (1.51)
    -17.7
    (1.48)
    -19.1
    (1.57)
    -15.4
    (1.56)
    -16.6
    (1.45)
    -15.9
    (1.51)
    Week 4
    -9.5
    (1.53)
    -14.9
    (1.45)
    -17.9
    (1.51)
    -17.6
    (1.47)
    -19.7
    (1.57)
    -15.9
    (1.56)
    -17.7
    (1.45)
    -17.1
    (1.51)
    Week 5
    -10.6
    (1.45)
    -15.4
    (1.37)
    -18.4
    (1.43)
    -18.6
    (1.40)
    -20.5
    (1.49)
    -16.9
    (1.48)
    -17.8
    (1.37)
    -17.2
    (1.44)
    Week 6
    -11.6
    (1.44)
    -16.4
    (1.36)
    -18.4
    (1.42)
    -19.4
    (1.39)
    -20.6
    (1.48)
    -16.9
    (1.47)
    -18.2
    (1.36)
    -18.1
    (1.43)
    Week 7
    -11.8
    (1.46)
    -16.2
    (1.38)
    -18.9
    (1.44)
    -19.1
    (1.41)
    -20.9
    (1.50)
    -17.4
    (1.49)
    -18.2
    (1.39)
    -18.3
    (1.45)
    Week 8
    -13.0
    (1.46)
    -16.3
    (1.38)
    -18.9
    (1.44)
    -19.5
    (1.42)
    -20.5
    (1.51)
    -17.4
    (1.50)
    -18.8
    (1.39)
    -18.7
    (1.45)
    Week 9
    -13.6
    (1.40)
    -17.6
    (1.32)
    -19.0
    (1.37)
    -20.2
    (1.36)
    -20.9
    (1.44)
    -17.3
    (1.43)
    -19.3
    (1.33)
    -18.7
    (1.39)
    Week 10
    -13.1
    (1.44)
    -17.9
    (1.37)
    -18.5
    (1.42)
    -20.1
    (1.41)
    -20.8
    (1.49)
    -18.2
    (1.48)
    -19.4
    (1.38)
    -19.1
    (1.44)
    Week 11
    -13.2
    (1.41)
    -17.9
    (1.33)
    -19.2
    (1.39)
    -20.9
    (1.38)
    -20.8
    (1.46)
    -18.6
    (1.45)
    -19.9
    (1.35)
    -19.2
    (1.41)
    Week 12
    -13.1
    (1.38)
    -18.2
    (1.31)
    -19.2
    (1.36)
    -20.7
    (1.35)
    -21.3
    (1.43)
    -18.7
    (1.42)
    -19.8
    (1.32)
    -19.4
    (1.38)
    Week 13
    -10.7
    (1.63)
    -16.0
    (1.46)
    -13.6
    (1.51)
    -12.7
    (1.57)
    -14.4
    (1.61)
    -16.3
    (1.62)
    -15.3
    (1.56)
    -13.3
    (1.54)
    Week 14
    -10.0
    (1.66)
    -14.1
    (1.50)
    -11.5
    (1.53)
    -11.5
    (1.63)
    -12.5
    (1.66)
    -15.3
    (1.67)
    -14.7
    (1.62)
    -12.3
    (1.57)
    Week 15
    -11.0
    (1.59)
    -12.3
    (1.46)
    -11.7
    (1.48)
    -10.8
    (1.61)
    -11.0
    (1.60)
    -13.6
    (1.65)
    -14.2
    (1.59)
    -10.9
    (1.51)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0142
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -8.62 to -0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.9
    Confidence Interval (2-Sided) 95%
    -11.73 to -4.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.1
    Confidence Interval (2-Sided) 95%
    -12.98 to -5.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -10.5
    Confidence Interval (2-Sided) 95%
    -14.39 to -6.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0819
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -7.36 to 0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.9
    Confidence Interval (2-Sided) 95%
    -10.78 to -3.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.9
    Confidence Interval (2-Sided) 95%
    -10.69 to -3.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0380
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.1
    Confidence Interval (2-Sided) 95%
    -8.01 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.6
    Confidence Interval (2-Sided) 95%
    -11.46 to -3.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.99
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -8.1
    Confidence Interval (2-Sided) 95%
    -11.96 to -4.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.2
    Confidence Interval (2-Sided) 95%
    -13.17 to -5.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.01
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0245
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.6
    Confidence Interval (2-Sided) 95%
    -8.52 to -0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.02
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.9
    Confidence Interval (2-Sided) 95%
    -9.83 to -2.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.99
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.53 to -1.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.61 to -1.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.7
    Confidence Interval (2-Sided) 95%
    -12.72 to -4.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.05
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.8
    Confidence Interval (2-Sided) 95%
    -12.78 to -4.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -10.2
    Confidence Interval (2-Sided) 95%
    -14.27 to -6.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.08
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.4
    Confidence Interval (2-Sided) 95%
    -10.54 to -2.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.08
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.7
    Confidence Interval (2-Sided) 95%
    -11.71 to -3.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.05
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -10.96 to -2.95
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.5
    Confidence Interval (2-Sided) 95%
    -9.46 to -1.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.03
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.4
    Confidence Interval (2-Sided) 95%
    -12.44 to -4.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.2
    Confidence Interval (2-Sided) 95%
    -12.15 to -4.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.03
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -10.2
    Confidence Interval (2-Sided) 95%
    -14.30 to -6.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.07
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.4
    Confidence Interval (2-Sided) 95%
    -10.46 to -2.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.06
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.3
    Confidence Interval (2-Sided) 95%
    -12.25 to -4.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.6
    Confidence Interval (2-Sided) 95%
    -11.58 to -3.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.02
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0123
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -8.60 to -1.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.8
    Confidence Interval (2-Sided) 95%
    -11.63 to -4.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.80 to -4.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.9
    Confidence Interval (2-Sided) 95%
    -13.73 to -6.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.3
    Confidence Interval (2-Sided) 95%
    -10.13 to -2.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -10.97 to -3.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.7
    Confidence Interval (2-Sided) 95%
    -10.41 to -2.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0119
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -8.54 to -1.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.8
    Confidence Interval (2-Sided) 95%
    -10.58 to -3.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.8
    Confidence Interval (2-Sided) 95%
    -11.57 to -4.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.1
    Confidence Interval (2-Sided) 95%
    -12.89 to -5.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0057
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.4
    Confidence Interval (2-Sided) 95%
    -9.18 to -1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.7
    Confidence Interval (2-Sided) 95%
    -10.40 to -2.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -10.27 to -2.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.89
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0210
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.5
    Confidence Interval (2-Sided) 95%
    -8.27 to -0.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -10.98 to -3.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.3
    Confidence Interval (2-Sided) 95%
    -11.12 to -3.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.1
    Confidence Interval (2-Sided) 95%
    -12.99 to -5.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0047
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.45 to -1.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.96
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -10.29 to -2.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -10.28 to -2.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0889
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.3
    Confidence Interval (2-Sided) 95%
    -7.10 to 0.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.9
    Confidence Interval (2-Sided) 95%
    -9.76 to -2.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -10.36 to -2.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.5
    Confidence Interval (2-Sided) 95%
    -11.36 to -3.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0255
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.4
    Confidence Interval (2-Sided) 95%
    -8.30 to -0.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -9.63 to -1.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.7
    Confidence Interval (2-Sided) 95%
    -9.45 to -1.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0316
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -7.59 to -0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0036
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.4
    Confidence Interval (2-Sided) 95%
    -9.02 to -1.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.6
    Confidence Interval (2-Sided) 95%
    -10.23 to -2.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.85
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -10.93 to -3.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.88
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0502
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -7.37 to 0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.87
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.28 to -1.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.85
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.1
    Confidence Interval (2-Sided) 95%
    -8.67 to -1.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0117
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -8.58 to -1.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0047
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.4
    Confidence Interval (2-Sided) 95%
    -9.17 to -1.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -10.80 to -3.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.7
    Confidence Interval (2-Sided) 95%
    -11.51 to -3.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0083
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.2
    Confidence Interval (2-Sided) 95%
    -8.97 to -1.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.3
    Confidence Interval (2-Sided) 95%
    -10.10 to -2.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.77 to -2.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0119
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.7
    Confidence Interval (2-Sided) 95%
    -8.37 to -1.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.61 to -2.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.7
    Confidence Interval (2-Sided) 95%
    -11.38 to -3.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.88
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.6
    Confidence Interval (2-Sided) 95%
    -11.33 to -3.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0051
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -9.07 to -1.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.89
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.6
    Confidence Interval (2-Sided) 95%
    -10.33 to -2.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.87
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.64 to -2.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.1
    Confidence Interval (2-Sided) 95%
    -8.67 to -1.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.82
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.1
    Confidence Interval (2-Sided) 95%
    -9.71 to -2.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.82
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.6
    Confidence Interval (2-Sided) 95%
    -11.20 to -3.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.2
    Confidence Interval (2-Sided) 95%
    -11.88 to -4.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.85
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.27 to -1.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.85
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.8
    Confidence Interval (2-Sided) 95%
    -10.35 to -3.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.83
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.3
    Confidence Interval (2-Sided) 95%
    -9.88 to -2.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.81
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0126
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -9.48 to -1.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.12
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1724
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -7.06 to 1.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.12
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3548
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -6.31 to 2.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.18
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0860
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.8
    Confidence Interval (2-Sided) 95%
    -8.04 to 0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.18
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0111
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.89 to -1.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.19
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0349
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.6
    Confidence Interval (2-Sided) 95%
    -8.94 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.19
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2205
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -6.77 to 1.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.12
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0645
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -8.29 to 0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.17
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5031
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -5.69 to 2.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.16
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5263
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -5.84 to 2.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.24
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2782
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -6.83 to 1.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.24
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0198
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -9.67 to -0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.24
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0417
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.6
    Confidence Interval (2-Sided) 95%
    -9.05 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.25
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2963
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -6.52 to 2.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.16
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5408
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -5.39 to 2.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.09
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7473
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -4.74 to 3.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.07
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9214
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -4.07 to 4.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.18
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9876
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -4.19 to 4.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.14
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2379
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -6.86 to 1.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.18
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1491
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.2
    Confidence Interval (2-Sided) 95%
    -7.45 to 1.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.18
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9560
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -3.96 to 4.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.07
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
    Description The hot flash score per 24h of moderate and severe VMS is calculated as follows: (number of moderate VMS x 2) + (number of severe VMS x 3). Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity.
    Time Frame Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    -5.1
    (1.49)
    -10.2
    (1.40)
    -13.4
    (1.46)
    -14.3
    (1.43)
    -15.7
    (1.51)
    -8.8
    (1.51)
    -12.2
    (1.40)
    -11.8
    (1.46)
    Week 2
    -8.9
    (1.51)
    -13.5
    (1.41)
    -17.0
    (1.48)
    -16.9
    (1.44)
    -18.2
    (1.53)
    -13.8
    (1.53)
    -15.5
    (1.42)
    -14.3
    (1.48)
    Week 3
    -8.9
    (1.54)
    -14.8
    (1.45)
    -18.2
    (1.52)
    -17.5
    (1.48)
    -19.1
    (1.57)
    -15.9
    (1.57)
    -17.3
    (1.46)
    -15.6
    (1.52)
    Week 4
    -9.5
    (1.54)
    -15.2
    (1.46)
    -18.3
    (1.51)
    -17.4
    (1.48)
    -19.6
    (1.57)
    -16.4
    (1.56)
    -18.0
    (1.45)
    -16.7
    (1.51)
    Week 5
    -10.5
    (1.46)
    -15.8
    (1.38)
    -18.8
    (1.44)
    -18.3
    (1.41)
    -20.3
    (1.50)
    -17.2
    (1.49)
    -18.2
    (1.38)
    -16.8
    (1.45)
    Week 6
    -11.5
    (1.45)
    -16.7
    (1.37)
    -18.7
    (1.43)
    -19.0
    (1.40)
    -20.3
    (1.49)
    -17.3
    (1.48)
    -18.6
    (1.37)
    -17.6
    (1.44)
    Week 7
    -11.8
    (1.47)
    -16.6
    (1.39)
    -19.2
    (1.45)
    -18.7
    (1.42)
    -20.6
    (1.51)
    -17.7
    (1.50)
    -18.5
    (1.39)
    -17.8
    (1.46)
    Week 8
    -13.0
    (1.47)
    -16.6
    (1.38)
    -19.1
    (1.44)
    -19.1
    (1.42)
    -20.2
    (1.51)
    -17.7
    (1.50)
    -19.0
    (1.39)
    -18.2
    (1.46)
    Week 9
    -13.5
    (1.41)
    -17.9
    (1.33)
    -19.3
    (1.38)
    -19.8
    (1.37)
    -20.5
    (1.45)
    -17.7
    (1.44)
    -19.4
    (1.34)
    -18.2
    (1.40)
    Week 10
    -12.9
    (1.45)
    -18.2
    (1.37)
    -18.9
    (1.42)
    -19.7
    (1.41)
    -20.4
    (1.49)
    -18.4
    (1.48)
    -19.5
    (1.38)
    -18.7
    (1.44)
    Week 11
    -13.0
    (1.42)
    -18.2
    (1.34)
    -19.4
    (1.39)
    -20.5
    (1.38)
    -20.5
    (1.46)
    -18.9
    (1.45)
    -19.9
    (1.35)
    -18.8
    (1.41)
    Week 12
    -12.8
    (1.39)
    -18.4
    (1.31)
    -19.3
    (1.36)
    -20.3
    (1.36)
    -21.0
    (1.43)
    -19.0
    (1.42)
    -19.8
    (1.32)
    -19.0
    (1.38)
    Week 13
    -10.4
    (1.65)
    -16.4
    (1.49)
    -13.8
    (1.54)
    -13.1
    (1.60)
    -14.4
    (1.64)
    -17.0
    (1.65)
    -15.4
    (1.59)
    -13.0
    (1.56)
    Week 14
    -9.7
    (1.70)
    -14.5
    (1.53)
    -11.5
    (1.57)
    -11.7
    (1.66)
    -12.5
    (1.69)
    -15.9
    (1.70)
    -14.6
    (1.66)
    -12.0
    (1.60)
    Week 15
    -10.7
    (1.65)
    -12.9
    (1.51)
    -11.6
    (1.53)
    -11.1
    (1.67)
    -10.9
    (1.66)
    -14.7
    (1.71)
    -14.1
    (1.65)
    -10.6
    (1.56)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0089
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.2
    Confidence Interval (2-Sided) 95%
    -9.01 to -1.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.96
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.4
    Confidence Interval (2-Sided) 95%
    -12.22 to -4.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.2
    Confidence Interval (2-Sided) 95%
    -13.06 to -5.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.96
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -10.7
    Confidence Interval (2-Sided) 95%
    -14.58 to -6.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.99
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0630
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -7.65 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.00
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -11.04 to -3.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.7
    Confidence Interval (2-Sided) 95%
    -10.53 to -2.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.96
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0231
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.5
    Confidence Interval (2-Sided) 95%
    -8.43 to -0.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.94 to -4.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.99
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.87 to -4.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.99
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.2
    Confidence Interval (2-Sided) 95%
    -13.21 to -5.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.02
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0177
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -8.80 to -0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.02
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -10.45 to -2.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.99
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0072
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.6
    Confidence Interval (2-Sided) 95%
    -9.26 to -2.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.9
    Confidence Interval (2-Sided) 95%
    -9.86 to -1.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.2
    Confidence Interval (2-Sided) 95%
    -13.27 to -5.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.05
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.6
    Confidence Interval (2-Sided) 95%
    -12.57 to -4.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -10.2
    Confidence Interval (2-Sided) 95%
    -14.29 to -6.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.08
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -11.04 to -2.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.08
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.4
    Confidence Interval (2-Sided) 95%
    -12.44 to -4.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.05
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.6
    Confidence Interval (2-Sided) 95%
    -10.65 to -2.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0053
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.7
    Confidence Interval (2-Sided) 95%
    -9.72 to -1.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.8
    Confidence Interval (2-Sided) 95%
    -12.77 to -4.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.8
    Confidence Interval (2-Sided) 95%
    -11.84 to -3.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -10.0
    Confidence Interval (2-Sided) 95%
    -14.12 to -5.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.07
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.9
    Confidence Interval (2-Sided) 95%
    -10.92 to -2.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.07
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.5
    Confidence Interval (2-Sided) 95%
    -12.49 to -4.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.04
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.1
    Confidence Interval (2-Sided) 95%
    -11.12 to -3.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.03
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0057
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.4
    Confidence Interval (2-Sided) 95%
    -9.15 to -1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.4
    Confidence Interval (2-Sided) 95%
    -12.15 to -4.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.9
    Confidence Interval (2-Sided) 95%
    -11.68 to -4.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -9.8
    Confidence Interval (2-Sided) 95%
    -13.66 to -5.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.96
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.7
    Confidence Interval (2-Sided) 95%
    -10.54 to -2.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.7
    Confidence Interval (2-Sided) 95%
    -11.55 to -3.95
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.4
    Confidence Interval (2-Sided) 95%
    -10.16 to -2.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.2
    Confidence Interval (2-Sided) 95%
    -8.99 to -1.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -10.94 to -3.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.5
    Confidence Interval (2-Sided) 95%
    -11.29 to -3.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.9
    Confidence Interval (2-Sided) 95%
    -12.69 to -5.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0030
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -9.62 to -1.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.1
    Confidence Interval (2-Sided) 95%
    -10.92 to -3.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.2
    Confidence Interval (2-Sided) 95%
    -9.91 to -2.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0137
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -8.61 to -0.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.4
    Confidence Interval (2-Sided) 95%
    -11.24 to -3.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -10.79 to -3.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.9
    Confidence Interval (2-Sided) 95%
    -12.74 to -4.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.98
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.9
    Confidence Interval (2-Sided) 95%
    -9.82 to -2.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.8
    Confidence Interval (2-Sided) 95%
    -10.60 to -2.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.82 to -2.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0588
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -7.46 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -9.90 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.2
    Confidence Interval (2-Sided) 95%
    -9.98 to -2.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -11.09 to -3.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0810
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.7
    Confidence Interval (2-Sided) 95%
    -8.55 to -0.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.97
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.1
    Confidence Interval (2-Sided) 95%
    -9.88 to -2.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0076
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.2
    Confidence Interval (2-Sided) 95%
    -8.98 to -1.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0182
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.4
    Confidence Interval (2-Sided) 95%
    -8.01 to -0.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.85
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -9.42 to -2.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.4
    Confidence Interval (2-Sided) 95%
    -10.02 to -2.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.1
    Confidence Interval (2-Sided) 95%
    -10.76 to -3.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.88
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0263
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -7.89 to -0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.88
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.61 to -2.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0113
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.7
    Confidence Interval (2-Sided) 95%
    -8.32 to -1.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -9.04 to -1.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.76 to -2.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.8
    Confidence Interval (2-Sided) 95%
    -10.62 to -3.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.6
    Confidence Interval (2-Sided) 95%
    -11.39 to -3.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.40 to -1.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.94
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.6
    Confidence Interval (2-Sided) 95%
    -10.40 to -2.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -9.57 to -2.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.2
    Confidence Interval (2-Sided) 95%
    -8.81 to -1.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.4
    Confidence Interval (2-Sided) 95%
    -10.06 to -2.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.5
    Confidence Interval (2-Sided) 95%
    -11.18 to -3.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.88
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.5
    Confidence Interval (2-Sided) 95%
    -11.18 to -3.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -9.56 to -2.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.89
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.9
    Confidence Interval (2-Sided) 95%
    -10.56 to -3.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.87
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -9.44 to -2.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -9.18 to -2.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.82
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -10.06 to -2.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.82
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.4
    Confidence Interval (2-Sided) 95%
    -11.05 to -3.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.84
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.1
    Confidence Interval (2-Sided) 95%
    -11.80 to -4.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.86
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.1
    Confidence Interval (2-Sided) 95%
    -9.77 to -2.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.85
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.9
    Confidence Interval (2-Sided) 95%
    -10.54 to -3.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.83
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.1
    Confidence Interval (2-Sided) 95%
    -9.71 to -2.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.82
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -10.26 to -1.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.15
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1145
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.4
    Confidence Interval (2-Sided) 95%
    -7.63 to 0.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.15
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2106
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -7.13 to 1.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.21
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0685
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -8.39 to 0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.21
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.7
    Confidence Interval (2-Sided) 95%
    -11.02 to -2.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.22
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0239
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -9.42 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.22
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2224
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -6.86 to 1.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.15
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0308
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -9.17 to -0.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.22
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4194
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -6.13 to 2.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.21
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3759
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -6.55 to 2.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.29
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2285
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -7.26 to 1.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.29
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0072
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.2
    Confidence Interval (2-Sided) 95%
    -10.71 to -1.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.29
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0338
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.9
    Confidence Interval (2-Sided) 95%
    -9.46 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.31
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3026
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -6.64 to 2.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.21
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3120
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -6.45 to 2.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.16
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6816
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -5.11 to 3.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.15
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8599
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -4.85 to 4.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.26
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9093
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -4.64 to 4.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.23
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0788
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -8.43 to 0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.26
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1278
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95%
    -7.92 to 1.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.26
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9848
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit and smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -4.19 to 4.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.15
    Estimation Comments
    11. Secondary Outcome
    Title Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    14.5
    (5.33)
    29.1
    (5.01)
    37.6
    (5.21)
    51.8
    (5.12)
    55.5
    (5.39)
    22.7
    (5.40)
    40.1
    (5.02)
    44.7
    (5.22)
    Week 2
    30.3
    (5.30)
    46.2
    (4.99)
    54.8
    (5.20)
    64.0
    (5.09)
    68.3
    (5.39)
    44.8
    (5.38)
    49.8
    (5.01)
    56.1
    (5.21)
    Week 3
    32.0
    (5.66)
    52.2
    (5.37)
    60.3
    (5.58)
    68.9
    (5.44)
    72.5
    (5.77)
    51.7
    (5.75)
    56.9
    (5.37)
    62.8
    (5.56)
    Week 4
    34.7
    (5.58)
    55.3
    (5.33)
    63.5
    (5.52)
    68.1
    (5.39)
    76.2
    (5.72)
    54.5
    (5.69)
    64.7
    (5.30)
    67.9
    (5.50)
    Week 5
    41.3
    (5.32)
    56.7
    (5.08)
    66.1
    (5.26)
    72.1
    (5.17)
    80.1
    (5.49)
    60.4
    (5.42)
    63.6
    (5.06)
    66.4
    (5.28)
    Week 6
    45.4
    (5.01)
    60.0
    (4.74)
    65.3
    (4.93)
    75.1
    (4.86)
    81.1
    (5.16)
    60.1
    (5.12)
    65.9
    (4.75)
    72.0
    (4.97)
    Week 7
    45.1
    (5.17)
    59.6
    (4.92)
    68.1
    (5.10)
    74.0
    (5.05)
    81.9
    (5.34)
    60.7
    (5.29)
    66.3
    (4.93)
    72.2
    (5.14)
    Week 8
    50.9
    (5.13)
    60.5
    (4.87)
    69.0
    (5.05)
    76.1
    (5.01)
    81.5
    (5.32)
    62.1
    (5.26)
    69.2
    (4.90)
    74.5
    (5.11)
    Week 9
    53.8
    (4.90)
    65.7
    (4.64)
    68.4
    (4.81)
    78.2
    (4.78)
    83.4
    (5.06)
    62.2
    (5.03)
    72.3
    (4.67)
    74.5
    (4.88)
    Week 10
    51.8
    (5.03)
    67.6
    (4.78)
    64.6
    (4.95)
    77.6
    (4.95)
    83.4
    (5.20)
    66.1
    (5.17)
    73.0
    (4.82)
    76.2
    (5.02)
    Week 11
    53.5
    (4.88)
    68.0
    (4.63)
    68.8
    (4.81)
    80.0
    (4.81)
    83.4
    (5.05)
    67.4
    (5.02)
    75.4
    (4.66)
    76.9
    (4.87)
    Week 12
    53.2
    (4.87)
    68.0
    (4.62)
    70.2
    (4.80)
    79.6
    (4.80)
    84.2
    (5.04)
    68.0
    (5.01)
    75.1
    (4.65)
    76.4
    (4.86)
    Week 13
    43.6
    (5.69)
    53.3
    (5.07)
    45.9
    (5.24)
    45.1
    (5.47)
    50.7
    (5.59)
    49.3
    (5.66)
    54.0
    (5.44)
    48.0
    (5.32)
    Week 14
    39.9
    (6.12)
    42.0
    (5.50)
    41.2
    (5.60)
    39.6
    (5.99)
    43.8
    (6.08)
    41.5
    (6.14)
    52.9
    (6.01)
    47.0
    (5.72)
    Week 15
    45.0
    (5.97)
    37.1
    (5.49)
    42.9
    (5.56)
    37.8
    (6.06)
    39.4
    (6.01)
    32.4
    (6.21)
    51.4
    (6.00)
    43.0
    (5.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0388
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments MMRM: Mixed Model Repeated Measures
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.6
    Confidence Interval (2-Sided) 95%
    0.76 to 28.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.05
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    9.17 to 37.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.08
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 37.3
    Confidence Interval (2-Sided) 95%
    23.41 to 51.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.07
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 41.0
    Confidence Interval (2-Sided) 95%
    26.88 to 55.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.16
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2569
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 8.2
    Confidence Interval (2-Sided) 95%
    -5.98 to 22.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.19
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.6
    Confidence Interval (2-Sided) 95%
    11.65 to 39.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.07
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 30.2
    Confidence Interval (2-Sided) 95%
    16.39 to 44.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.03
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0240
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 15.9
    Confidence Interval (2-Sided) 95%
    2.11 to 29.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.02
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.5
    Confidence Interval (2-Sided) 95%
    10.62 to 38.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.05
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value 33.7
    Confidence Interval (2-Sided) 95%
    19.87 to 47.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.03
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 38.0
    Confidence Interval (2-Sided) 95%
    23.93 to 52.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.15
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0441
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.5
    Confidence Interval (2-Sided) 95%
    0.38 to 28.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.16
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.4
    Confidence Interval (2-Sided) 95%
    5.58 to 33.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.04
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.7
    Confidence Interval (2-Sided) 95%
    11.96 to 39.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.01
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0078
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.2
    Confidence Interval (2-Sided) 95%
    5.36 to 35.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.55
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 28.3
    Confidence Interval (2-Sided) 95%
    13.36 to 43.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.59
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 36.9
    Confidence Interval (2-Sided) 95%
    22.07 to 51.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.55
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRm
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 40.5
    Confidence Interval (2-Sided) 95%
    25.41 to 55.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.69
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0108
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.7
    Confidence Interval (2-Sided) 95%
    4.59 to 34.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.70
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.0
    Confidence Interval (2-Sided) 95%
    10.09 to 39.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.56
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 30.9
    Confidence Interval (2-Sided) 95%
    16.03 to 45.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.53
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.5
    Confidence Interval (2-Sided) 95%
    5.84 to 35.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.47
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 28.7
    Confidence Interval (2-Sided) 95%
    13.98 to 43.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.49
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 33.3
    Confidence Interval (2-Sided) 95%
    18.66 to 48.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.46
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 41.5
    Confidence Interval (2-Sided) 95%
    26.52 to 56.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.60
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0098
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.7
    Confidence Interval (2-Sided) 95%
    4.78 to 34.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.59
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.9
    Confidence Interval (2-Sided) 95%
    15.26 to 44.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.46
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 33.1
    Confidence Interval (2-Sided) 95%
    18.50 to 47.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.43
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0303
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 15.4
    Confidence Interval (2-Sided) 95%
    1.48 to 29.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.10
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.8
    Confidence Interval (2-Sided) 95%
    10.77 to 38.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.11
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 30.8
    Confidence Interval (2-Sided) 95%
    16.77 to 44.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.11
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 38.8
    Confidence Interval (2-Sided) 95%
    24.55 to 53.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.23
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0086
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.1
    Confidence Interval (2-Sided) 95%
    4.88 to 33.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.20
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.3
    Confidence Interval (2-Sided) 95%
    8.33 to 36.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.09
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.1
    Confidence Interval (2-Sided) 95%
    11.24 to 39.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.07
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0282
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.6
    Confidence Interval (2-Sided) 95%
    1.56 to 27.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.62
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.9
    Confidence Interval (2-Sided) 95%
    6.85 to 32.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.63
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.7
    Confidence Interval (2-Sided) 95%
    16.58 to 42.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.65
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 35.7
    Confidence Interval (2-Sided) 95%
    22.42 to 48.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.75
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0304
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.6
    Confidence Interval (2-Sided) 95%
    1.40 to 27.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.74
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.4
    Confidence Interval (2-Sided) 95%
    7.38 to 33.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.64
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 26.5
    Confidence Interval (2-Sided) 95%
    13.56 to 39.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.59
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0362
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.4
    Confidence Interval (2-Sided) 95%
    0.93 to 27.95
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.87
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.9
    Confidence Interval (2-Sided) 95%
    9.41 to 36.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.88
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 28.9
    Confidence Interval (2-Sided) 95%
    15.27 to 42.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.91
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 36.8
    Confidence Interval (2-Sided) 95%
    22.99 to 50.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.01
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0265
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 15.6
    Confidence Interval (2-Sided) 95%
    1.83 to 29.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.99
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 21.2
    Confidence Interval (2-Sided) 95%
    7.60 to 34.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.89
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 27.1
    Confidence Interval (2-Sided) 95%
    13.64 to 40.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.85
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1580
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 9.6
    Confidence Interval (2-Sided) 95%
    -3.75 to 22.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.80
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0082
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 18.1
    Confidence Interval (2-Sided) 95%
    4.72 to 31.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.80
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.2
    Confidence Interval (2-Sided) 95%
    11.77 to 38.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.85
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 30.6
    Confidence Interval (2-Sided) 95%
    16.93 to 44.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.96
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1074
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 11.2
    Confidence Interval (2-Sided) 95%
    -2.45 to 24.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.93
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0077
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 18.3
    Confidence Interval (2-Sided) 95%
    4.87 to 31.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.83
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.6
    Confidence Interval (2-Sided) 95%
    10.29 to 37.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.79
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0689
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 11.8
    Confidence Interval (2-Sided) 95%
    -0.92 to 24.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.47
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0250
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.6
    Confidence Interval (2-Sided) 95%
    1.84 to 27.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.46
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.4
    Confidence Interval (2-Sided) 95%
    11.54 to 37.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.51
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.6
    Confidence Interval (2-Sided) 95%
    16.60 to 42.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.60
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2041
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 8.4
    Confidence Interval (2-Sided) 95%
    -4.58 to 21.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.59
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 18.4
    Confidence Interval (2-Sided) 95%
    5.62 to 31.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.50
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.7
    Confidence Interval (2-Sided) 95%
    8.00 to 33.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.45
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0184
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 15.8
    Confidence Interval (2-Sided) 95%
    2.68 to 28.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.66
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0551
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 12.8
    Confidence Interval (2-Sided) 95%
    -0.28 to 25.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.66
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.8
    Confidence Interval (2-Sided) 95%
    12.51 to 39.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.73
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 31.6
    Confidence Interval (2-Sided) 95%
    18.17 to 44.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.80
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0367
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.3
    Confidence Interval (2-Sided) 95%
    0.89 to 27.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.79
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 21.2
    Confidence Interval (2-Sided) 95%
    7.99 to 34.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.70
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.4
    Confidence Interval (2-Sided) 95%
    11.29 to 37.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.65
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0255
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.5
    Confidence Interval (2-Sided) 95%
    1.78 to 27.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.45
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0186
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 15.3
    Confidence Interval (2-Sided) 95%
    2.57 to 27.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.45
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 26.5
    Confidence Interval (2-Sided) 95%
    13.71 to 39.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.52
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.9
    Confidence Interval (2-Sided) 95%
    16.94 to 42.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.58
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0347
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 13.9
    Confidence Interval (2-Sided) 95%
    1.01 to 26.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.57
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 21.9
    Confidence Interval (2-Sided) 95%
    9.16 to 34.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.48
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.4
    Confidence Interval (2-Sided) 95%
    10.75 to 36.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.43
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0221
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.8
    Confidence Interval (2-Sided) 95%
    2.13 to 27.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.43
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0087
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 17.0
    Confidence Interval (2-Sided) 95%
    4.32 to 29.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.43
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 26.4
    Confidence Interval (2-Sided) 95%
    13.65 to 39.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.50
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 31.0
    Confidence Interval (2-Sided) 95%
    18.13 to 43.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.56
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0244
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.8
    Confidence Interval (2-Sided) 95%
    1.92 to 27.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.55
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 21.9
    Confidence Interval (2-Sided) 95%
    9.21 to 34.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.46
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.2
    Confidence Interval (2-Sided) 95%
    10.63 to 35.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.41
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1871
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 9.8
    Confidence Interval (2-Sided) 95%
    -4.77 to 24.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.38
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7552
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    -12.23 to 16.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.38
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8407
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    -13.44 to 16.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.61
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3450
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 7.2
    Confidence Interval (2-Sided) 95%
    -7.77 to 22.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.60
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4550
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 5.7
    Confidence Interval (2-Sided) 95%
    -9.34 to 20.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.66
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1747
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 10.4
    Confidence Interval (2-Sided) 95%
    -4.64 to 25.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.64
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5476
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 4.4
    Confidence Interval (2-Sided) 95%
    -10.08 to 18.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.38
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7954
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.1
    Confidence Interval (2-Sided) 95%
    -13.69 to 17.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.01
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8731
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -14.41 to 16.95
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.96
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9689
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -16.68 to 16.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.31
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6378
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.9
    Confidence Interval (2-Sided) 95%
    -12.40 to 20.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.28
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8503
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    -14.82 to 17.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.33
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1224
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 13.0
    Confidence Interval (2-Sided) 95%
    -3.51 to 29.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.37
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3743
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 7.1
    Confidence Interval (2-Sided) 95%
    -8.62 to 22.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.99
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3173
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.9
    Confidence Interval (2-Sided) 95%
    -23.44 to 7.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.89
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7905
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -17.48 to 13.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.82
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3804
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -23.46 to 8.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.24
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4905
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -21.58 to 10.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.11
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1289
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -12.6
    Confidence Interval (2-Sided) 95%
    -28.83 to 3.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.25
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4398
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.4
    Confidence Interval (2-Sided) 95%
    -9.86 to 22.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.24
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7921
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -17.45 to 13.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.81
    Estimation Comments
    12. Secondary Outcome
    Title Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    17.5
    (5.51)
    36.6
    (5.18)
    44.5
    (5.39)
    57.0
    (5.30)
    62.3
    (5.57)
    29.6
    (5.59)
    45.3
    (5.20)
    47.0
    (5.40)
    Week 2
    33.8
    (5.34)
    53.7
    (5.01)
    62.4
    (5.23)
    67.6
    (5.12)
    73.3
    (5.42)
    51.4
    (5.41)
    57.9
    (5.03)
    57.7
    (5.25)
    Week 3
    34.8
    (5.61)
    58.1
    (5.31)
    69.2
    (5.53)
    70.5
    (5.40)
    77.8
    (5.73)
    60.3
    (5.71)
    66.0
    (5.32)
    63.7
    (5.52)
    Week 4
    38.6
    (5.57)
    61.7
    (5.31)
    70.7
    (5.50)
    70.0
    (5.37)
    80.5
    (5.71)
    64.2
    (5.68)
    70.0
    (5.28)
    68.1
    (5.49)
    Week 5
    43.6
    (5.31)
    63.8
    (5.06)
    74.2
    (5.25)
    72.7
    (5.17)
    83.7
    (5.49)
    68.0
    (5.42)
    70.3
    (5.04)
    67.0
    (5.28)
    Week 6
    48.5
    (5.02)
    67.7
    (4.75)
    72.4
    (4.94)
    75.7
    (4.87)
    84.1
    (5.19)
    68.5
    (5.14)
    72.6
    (4.76)
    71.7
    (4.99)
    Week 7
    49.1
    (5.16)
    66.7
    (4.90)
    74.9
    (5.09)
    74.9
    (5.04)
    85.4
    (5.34)
    69.7
    (5.28)
    72.0
    (4.91)
    71.9
    (5.14)
    Week 8
    54.5
    (5.09)
    68.3
    (4.81)
    74.5
    (5.01)
    76.6
    (4.96)
    84.5
    (5.28)
    69.4
    (5.23)
    74.1
    (4.85)
    74.1
    (5.08)
    Week 9
    56.4
    (4.91)
    72.4
    (4.64)
    74.5
    (4.82)
    79.0
    (4.78)
    85.7
    (5.08)
    70.1
    (5.05)
    76.5
    (4.68)
    73.8
    (4.90)
    Week 10
    53.5
    (5.03)
    74.2
    (4.77)
    72.3
    (4.95)
    77.9
    (4.95)
    85.6
    (5.21)
    72.6
    (5.18)
    76.6
    (4.81)
    76.4
    (5.03)
    Week 11
    55.6
    (4.82)
    74.1
    (4.55)
    75.8
    (4.75)
    80.6
    (4.73)
    85.4
    (4.99)
    75.1
    (4.96)
    79.0
    (4.59)
    77.3
    (4.82)
    Week 12
    55.0
    (4.85)
    74.3
    (4.58)
    75.8
    (4.77)
    80.2
    (4.77)
    86.9
    (5.02)
    75.1
    (4.99)
    77.7
    (4.61)
    76.9
    (4.84)
    Week 13
    44.9
    (6.02)
    61.9
    (5.37)
    51.7
    (5.55)
    52.5
    (5.78)
    55.8
    (5.92)
    61.3
    (5.98)
    56.6
    (5.76)
    48.8
    (5.63)
    Week 14
    41.0
    (6.47)
    50.4
    (5.83)
    44.9
    (5.93)
    45.9
    (6.34)
    47.2
    (6.44)
    51.4
    (6.49)
    55.3
    (6.36)
    47.7
    (6.06)
    Week 15
    45.6
    (6.49)
    44.7
    (5.98)
    45.6
    (6.04)
    46.0
    (6.61)
    41.7
    (6.54)
    45.5
    (6.76)
    53.2
    (6.57)
    42.9
    (6.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0090
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments MMRM: Mixed Model Repeated Measures
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.1
    Confidence Interval (2-Sided) 95%
    4.82 to 33.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.28
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 27.0
    Confidence Interval (2-Sided) 95%
    12.61 to 41.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.32
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 39.5
    Confidence Interval (2-Sided) 95%
    25.14 to 53.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.31
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 44.8
    Confidence Interval (2-Sided) 95%
    30.27 to 59.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.40
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1019
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 12.2
    Confidence Interval (2-Sided) 95%
    -2.43 to 26.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.43
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 27.8
    Confidence Interval (2-Sided) 95%
    13.45 to 42.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.31
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.5
    Confidence Interval (2-Sided) 95%
    15.21 to 43.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.27
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.9
    Confidence Interval (2-Sided) 95%
    6.10 to 33.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.03
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 28.6
    Confidence Interval (2-Sided) 95%
    14.64 to 42.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.07
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value 33.8
    Confidence Interval (2-Sided) 95%
    19.96 to 47.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.05
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 39.5
    Confidence Interval (2-Sided) 95%
    25.40 to 53.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.16
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0146
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 17.6
    Confidence Interval (2-Sided) 95%
    3.50 to 31.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.17
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.1
    Confidence Interval (2-Sided) 95%
    10.21 to 38.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.06
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.9
    Confidence Interval (2-Sided) 95%
    10.05 to 37.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.03
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.2
    Confidence Interval (2-Sided) 95%
    8.56 to 37.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.46
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 34.4
    Confidence Interval (2-Sided) 95%
    19.60 to 49.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.50
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 35.6
    Confidence Interval (2-Sided) 95%
    20.96 to 50.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.46
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 43.0
    Confidence Interval (2-Sided) 95%
    28.03 to 57.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.60
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.4
    Confidence Interval (2-Sided) 95%
    10.48 to 40.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.60
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 31.2
    Confidence Interval (2-Sided) 95%
    16.49 to 45.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.48
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 28.9
    Confidence Interval (2-Sided) 95%
    14.24 to 43.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.44
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    8.46 to 37.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.42
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 32.1
    Confidence Interval (2-Sided) 95%
    17.42 to 46.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.45
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 31.3
    Confidence Interval (2-Sided) 95%
    16.73 to 45.91
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.42
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 41.8
    Confidence Interval (2-Sided) 95%
    26.95 to 56.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.56
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.6
    Confidence Interval (2-Sided) 95%
    10.77 to 40.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.54
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 31.3
    Confidence Interval (2-Sided) 95%
    16.75 to 45.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.42
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.4
    Confidence Interval (2-Sided) 95%
    14.91 to 43.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.39
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.2
    Confidence Interval (2-Sided) 95%
    6.31 to 34.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.05
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 30.6
    Confidence Interval (2-Sided) 95%
    16.68 to 44.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.07
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.1
    Confidence Interval (2-Sided) 95%
    15.14 to 42.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.08
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 40.1
    Confidence Interval (2-Sided) 95%
    25.96 to 54.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.19
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.4
    Confidence Interval (2-Sided) 95%
    10.28 to 38.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.15
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 26.7
    Confidence Interval (2-Sided) 95%
    1.78 to 40.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.06
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.4
    Confidence Interval (2-Sided) 95%
    9.55 to 37.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.03
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.1
    Confidence Interval (2-Sided) 95%
    6.13 to 32.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.60
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.8
    Confidence Interval (2-Sided) 95%
    10.80 to 36.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.62
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 27.2
    Confidence Interval (2-Sided) 95%
    14.10 to 40.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.64
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 35.6
    Confidence Interval (2-Sided) 95%
    22.34 to 48.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.75
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.0
    Confidence Interval (2-Sided) 95%
    6.76 to 33.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.72
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.1
    Confidence Interval (2-Sided) 95%
    11.02 to 37.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.64
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    10.17 to 36.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.59
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0102
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 17.6
    Confidence Interval (2-Sided) 95%
    4.20 to 31.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.82
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.9
    Confidence Interval (2-Sided) 95%
    12.42 to 39.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.83
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.8
    Confidence Interval (2-Sided) 95%
    12.29 to 39.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.87
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 36.3
    Confidence Interval (2-Sided) 95%
    22.58 to 49.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.97
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.6
    Confidence Interval (2-Sided) 95%
    7.00 to 34.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.94
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.9
    Confidence Interval (2-Sided) 95%
    9.43 to 36.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.85
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.8
    Confidence Interval (2-Sided) 95%
    9.42 to 36.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.80
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0408
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 13.8
    Confidence Interval (2-Sided) 95%
    0.58 to 26.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.71
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.0
    Confidence Interval (2-Sided) 95%
    6.77 to 33.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.72
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.1
    Confidence Interval (2-Sided) 95%
    8.80 to 35.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.76
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.9
    Confidence Interval (2-Sided) 95%
    16.39 to 43.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.87
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0303
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.9
    Confidence Interval (2-Sided) 95%
    1.42 to 28.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.84
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.6
    Confidence Interval (2-Sided) 95%
    6.30 to 32.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.75
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0038
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.5
    Confidence Interval (2-Sided) 95%
    6.34 to 32.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.71
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0137
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 16.0
    Confidence Interval (2-Sided) 95%
    3.29 to 28.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.45
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0052
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 18.1
    Confidence Interval (2-Sided) 95%
    5.44 to 30.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.45
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.6
    Confidence Interval (2-Sided) 95%
    9.81 to 35.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.50
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.4
    Confidence Interval (2-Sided) 95%
    16.41 to 42.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.58
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0378
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 13.7
    Confidence Interval (2-Sided) 95%
    0.78 to 26.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.57
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.1
    Confidence Interval (2-Sided) 95%
    7.31 to 32.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.49
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0071
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 17.4
    Confidence Interval (2-Sided) 95%
    4.77 to 30.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.44
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.7
    Confidence Interval (2-Sided) 95%
    7.61 to 33.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.63
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0050
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 18.7
    Confidence Interval (2-Sided) 95%
    5.68 to 31.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.63
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 24.4
    Confidence Interval (2-Sided) 95%
    11.20 to 37.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.71
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 32.1
    Confidence Interval (2-Sided) 95%
    18.77 to 45.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.77
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Wek 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0050
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.1
    Confidence Interval (2-Sided) 95%
    5.79 to 32.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.76
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    9.95 to 36.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.68
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.8
    Confidence Interval (2-Sided) 95%
    9.79 to 35.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.62
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0036
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 18.5
    Confidence Interval (2-Sided) 95%
    6.11 to 30.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.32
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.2
    Confidence Interval (2-Sided) 95%
    7.77 to 32.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.32
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.0
    Confidence Interval (2-Sided) 95%
    12.41 to 37.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.39
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 29.8
    Confidence Interval (2-Sided) 95%
    17.12 to 42.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.45
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.6
    Confidence Interval (2-Sided) 95%
    6.90 to 32.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.43
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 23.4
    Confidence Interval (2-Sided) 95%
    10.92 to 35.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.36
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 21.7
    Confidence Interval (2-Sided) 95%
    9.34 to 34.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.30
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 19.3
    Confidence Interval (2-Sided) 95%
    6.78 to 31.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.37
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.8
    Confidence Interval (2-Sided) 95%
    8.29 to 33.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.36
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 25.1
    Confidence Interval (2-Sided) 95%
    12.48 to 37.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.44
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 31.9
    Confidence Interval (2-Sided) 95%
    19.11 to 44.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.50
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 20.1
    Confidence Interval (2-Sided) 95%
    7.32 to 32.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.48
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 22.7
    Confidence Interval (2-Sided) 95%
    10.10 to 35.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.40
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 21.9
    Confidence Interval (2-Sided) 95%
    9.42 to 34.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.34
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0304
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 17.0
    Confidence Interval (2-Sided) 95%
    1.62 to 32.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.82
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3857
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.8
    Confidence Interval (2-Sided) 95%
    -8.60 to 22.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.82
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3497
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 7.5
    Confidence Interval (2-Sided) 95%
    -8.31 to 23.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.06
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1771
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 10.9
    Confidence Interval (2-Sided) 95%
    -4.95 to 26.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.05
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0444
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 16.3
    Confidence Interval (2-Sided) 95%
    0.41 to 32.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.10
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1500
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 11.7
    Confidence Interval (2-Sided) 95%
    -4.25 to 27.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.10
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6196
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.9
    Confidence Interval (2-Sided) 95%
    -11.51 to 19.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.83
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2664
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 9.4
    Confidence Interval (2-Sided) 95%
    -7.25 to 26.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.48
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6388
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    -12.66 to 20.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.44
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5797
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 4.9
    Confidence Interval (2-Sided) 95%
    -12.43 to 22.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.79
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4817
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.2
    Confidence Interval (2-Sided) 95%
    -11.10 to 23.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.78
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2358
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value 10.5
    Confidence Interval (2-Sided) 95%
    -6.87 to 27.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.80
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1070
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 14.3
    Confidence Interval (2-Sided) 95%
    -3.11 to 31.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.86
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4268
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.7
    Confidence Interval (2-Sided) 95%
    -9.94 to 23.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.47
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9197
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -17.81 to 16.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.61
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9954
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -16.77 to 16.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.54
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9607
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -17.28 to 18.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.00
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6625
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.9
    Confidence Interval (2-Sided) 95%
    -21.33 to 13.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.87
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9952
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -17.81 to 17.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.01
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4001
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & BM as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 7.6
    Confidence Interval (2-Sided) 95%
    -10.16 to 25.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.02
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7510
    Comments LSM, SE, CI, & p-values come from an MMRM model with PR from baseline as dependent variable & TG, visit and smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -19.52 to 14.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.54
    Estimation Comments
    13. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    5
    11.6%
    19
    42.2%
    22
    51.2%
    24
    53.3%
    25
    56.8%
    10
    23.3%
    21
    46.7%
    23
    52.3%
    Week 2
    14
    32.6%
    26
    57.8%
    29
    67.4%
    32
    71.1%
    30
    68.2%
    22
    51.2%
    26
    57.8%
    28
    63.6%
    Week 3
    16
    37.2%
    26
    57.8%
    29
    67.4%
    33
    73.3%
    32
    72.7%
    26
    60.5%
    29
    64.4%
    29
    65.9%
    Week 4
    19
    44.2%
    26
    57.8%
    29
    67.4%
    31
    68.9%
    31
    70.5%
    25
    58.1%
    32
    71.1%
    31
    70.5%
    Week 5
    22
    51.2%
    24
    53.3%
    31
    72.1%
    30
    66.7%
    29
    65.9%
    28
    65.1%
    30
    66.7%
    29
    65.9%
    Week 6
    24
    55.8%
    24
    53.3%
    30
    69.8%
    31
    68.9%
    28
    63.6%
    24
    55.8%
    30
    66.7%
    33
    75%
    Week 7
    25
    58.1%
    25
    55.6%
    32
    74.4%
    29
    64.4%
    28
    63.6%
    28
    65.1%
    30
    66.7%
    30
    68.2%
    Week 8
    26
    60.5%
    28
    62.2%
    32
    74.4%
    32
    71.1%
    28
    63.6%
    25
    58.1%
    31
    68.9%
    32
    72.7%
    Week 9
    27
    62.8%
    29
    64.4%
    33
    76.7%
    31
    68.9%
    31
    70.5%
    25
    58.1%
    30
    66.7%
    31
    70.5%
    Week 10
    23
    53.5%
    28
    62.2%
    26
    60.5%
    26
    57.8%
    31
    70.5%
    26
    60.5%
    32
    71.1%
    32
    72.7%
    Week 11
    23
    53.5%
    28
    62.2%
    30
    69.8%
    25
    55.6%
    30
    68.2%
    27
    62.8%
    33
    73.3%
    31
    70.5%
    Week 12
    21
    48.8%
    27
    60%
    27
    62.8%
    27
    60%
    28
    63.6%
    24
    55.8%
    32
    71.1%
    32
    72.7%
    Week 13
    12
    27.9%
    19
    42.2%
    17
    39.5%
    14
    31.1%
    15
    34.1%
    16
    37.2%
    14
    31.1%
    17
    38.6%
    Week 14
    11
    25.6%
    14
    31.1%
    15
    34.9%
    10
    22.2%
    13
    29.5%
    15
    34.9%
    14
    31.1%
    17
    38.6%
    Week 15
    14
    32.6%
    10
    22.2%
    12
    27.9%
    6
    13.3%
    9
    20.5%
    9
    20.9%
    12
    26.7%
    13
    29.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.02
    Confidence Interval (2-Sided) 95%
    1.95 to 18.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.28
    Confidence Interval (2-Sided) 95%
    2.70 to 25.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.92
    Confidence Interval (2-Sided) 95%
    3.53 to 33.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.18
    Confidence Interval (2-Sided) 95%
    3.91 to 37.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2244
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.10
    Confidence Interval (2-Sided) 95%
    0.64 to 6.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.58
    Confidence Interval (2-Sided) 95%
    2.77 to 26.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.25
    Confidence Interval (2-Sided) 95%
    2.71 to 25.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0149
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.04
    Confidence Interval (2-Sided) 95%
    1.24 to 7.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.65
    Confidence Interval (2-Sided) 95%
    1.85 to 11.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.36
    Confidence Interval (2-Sided) 95%
    2.46 to 16.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.87
    Confidence Interval (2-Sided) 95%
    2.56 to 18.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0897
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.18
    Confidence Interval (2-Sided) 95%
    0.89 to 5.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.46
    Confidence Interval (2-Sided) 95%
    1.42 to 8.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0041
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.75
    Confidence Interval (2-Sided) 95%
    1.52 to 9.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0254
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.77
    Confidence Interval (2-Sided) 95%
    1.13 to 6.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.00
    Confidence Interval (2-Sided) 95%
    1.59 to 10.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.25
    Confidence Interval (2-Sided) 95%
    2.37 to 16.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.78
    Confidence Interval (2-Sided) 95%
    3.00 to 25.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0214
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.90
    Confidence Interval (2-Sided) 95%
    1.17 to 7.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.67
    Confidence Interval (2-Sided) 95%
    1.48 to 9.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0078
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.36
    Confidence Interval (2-Sided) 95%
    1.38 to 8.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0727
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.28
    Confidence Interval (2-Sided) 95%
    0.93 to 5.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.94
    Confidence Interval (2-Sided) 95%
    1.19 to 7.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.21
    Confidence Interval (2-Sided) 95%
    1.61 to 11.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.26
    Confidence Interval (2-Sided) 95%
    2.16 to 18.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1206
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.02
    Confidence Interval (2-Sided) 95%
    0.83 to 4.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.58
    Confidence Interval (2-Sided) 95%
    1.42 to 9.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0088
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.41
    Confidence Interval (2-Sided) 95%
    1.36 to 8.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4485
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.41
    Confidence Interval (2-Sided) 95%
    0.58 to 3.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0255
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.92
    Confidence Interval (2-Sided) 95%
    1.14 to 7.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0066
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.18
    Confidence Interval (2-Sided) 95%
    1.49 to 11.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.46
    Confidence Interval (2-Sided) 95%
    1.53 to 13.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0879
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.89 to 5.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0389
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.68
    Confidence Interval (2-Sided) 95%
    1.05 to 6.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0446
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    1.02 to 6.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8196
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.45 to 2.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1450
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.00
    Confidence Interval (2-Sided) 95%
    0.79 to 5.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0114
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.08
    Confidence Interval (2-Sided) 95%
    1.37 to 12.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0307
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.29
    Confidence Interval (2-Sided) 95%
    1.12 to 9.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5921
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.29
    Confidence Interval (2-Sided) 95%
    0.51 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0502
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.69
    Confidence Interval (2-Sided) 95%
    1.00 to 7.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0224
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.31
    Confidence Interval (2-Sided) 95%
    1.18 to 9.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7225
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    0.47 to 2.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0762
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.43
    Confidence Interval (2-Sided) 95%
    0.91 to 6.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0252
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.51
    Confidence Interval (2-Sided) 95%
    1.17 to 10.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0490
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.98
    Confidence Interval (2-Sided) 95%
    1.00 to 8.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1773
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.97
    Confidence Interval (2-Sided) 95%
    0.74 to 5.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0609
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    0.96 to 7.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1364
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.11
    Confidence Interval (2-Sided) 95%
    0.79 to 5.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5268
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.36
    Confidence Interval (2-Sided) 95%
    0.53 to 3.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1645
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.02
    Confidence Interval (2-Sided) 95%
    0.75 to 5.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0215
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    1.22 to 12.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0600
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.04
    Confidence Interval (2-Sided) 95%
    0.95 to 9.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6503
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    0.47 to 3.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0683
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    0.93 to 7.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0618
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.83
    Confidence Interval (2-Sided) 95%
    0.95 to 8.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5621
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.34
    Confidence Interval (2-Sided) 95%
    0.50 to 3.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2182
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.92
    Confidence Interval (2-Sided) 95%
    0.68 to 5.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0600
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.11
    Confidence Interval (2-Sided) 95%
    0.95 to 10.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0290
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.60
    Confidence Interval (2-Sided) 95%
    1.17 to 18.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8485
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    0.40 to 3.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1652
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.16
    Confidence Interval (2-Sided) 95%
    0.73 to 6.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2244
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.94
    Confidence Interval (2-Sided) 95%
    0.67 to 5.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2097
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.85
    Confidence Interval (2-Sided) 95%
    0.71 to 4.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3708
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.53
    Confidence Interval (2-Sided) 95%
    0.60 to 3.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0704
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.66
    Confidence Interval (2-Sided) 95%
    0.92 to 7.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.21
    Confidence Interval (2-Sided) 95%
    1.88 to 27.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1625
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.04
    Confidence Interval (2-Sided) 95%
    0.75 to 5.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0093
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.59
    Confidence Interval (2-Sided) 95%
    1.46 to 14.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0103
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.44
    Confidence Interval (2-Sided) 95%
    1.42 to 13.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1965
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.89
    Confidence Interval (2-Sided) 95%
    0.72 to 4.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0549
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.69
    Confidence Interval (2-Sided) 95%
    0.98 to 7.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0503
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.01
    Confidence Interval (2-Sided) 95%
    1.00 to 9.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.03
    Confidence Interval (2-Sided) 95%
    1.82 to 27.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0866
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.46
    Confidence Interval (2-Sided) 95%
    0.88 to 6.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.96
    Confidence Interval (2-Sided) 95%
    1.74 to 20.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0207
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.59
    Confidence Interval (2-Sided) 95%
    1.22 to 10.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2127
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.86
    Confidence Interval (2-Sided) 95%
    0.70 to 4.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1521
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.04
    Confidence Interval (2-Sided) 95%
    0.77 to 5.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0098
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.12
    Confidence Interval (2-Sided) 95%
    1.48 to 17.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0047
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.08
    Confidence Interval (2-Sided) 95%
    1.82 to 27.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1817
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.00
    Confidence Interval (2-Sided) 95%
    0.72 to 5.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.09
    Confidence Interval (2-Sided) 95%
    1.77 to 20.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0039
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.09
    Confidence Interval (2-Sided) 95%
    1.78 to 20.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7025
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.23
    Confidence Interval (2-Sided) 95%
    0.42 to 3.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9599
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.36 to 2.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9671
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.34 to 3.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6810
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.26
    Confidence Interval (2-Sided) 95%
    0.42 to 3.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6346
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.43 to 4.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7929
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.16
    Confidence Interval (2-Sided) 95%
    0.38 to 3.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8188
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.13
    Confidence Interval (2-Sided) 95%
    0.39 to 3.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8226
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95%
    0.30 to 2.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9088
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.32 to 2.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6189
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.24 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6463
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.30
    Confidence Interval (2-Sided) 95%
    0.42 to 4.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.47 to 4.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3842
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.67
    Confidence Interval (2-Sided) 95%
    0.53 to 5.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5021
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.44
    Confidence Interval (2-Sided) 95%
    0.49 to 4.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1349
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.42
    Confidence Interval (2-Sided) 95%
    0.14 to 1.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3191
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.57
    Confidence Interval (2-Sided) 95%
    0.19 to 1.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0623
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.30
    Confidence Interval (2-Sided) 95%
    0.09 to 1.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1958
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.47
    Confidence Interval (2-Sided) 95%
    0.15 to 1.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4353
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.19 to 2.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9729
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.31 to 3.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4211
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.64
    Confidence Interval (2-Sided) 95%
    0.22 to 1.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    2
    4.7%
    6
    13.3%
    11
    25.6%
    17
    37.8%
    18
    40.9%
    6
    14%
    7
    15.6%
    16
    36.4%
    Week 2
    9
    20.9%
    15
    33.3%
    19
    44.2%
    26
    57.8%
    24
    54.5%
    13
    30.2%
    13
    28.9%
    21
    47.7%
    Week 3
    11
    25.6%
    17
    37.8%
    20
    46.5%
    27
    60%
    27
    61.4%
    17
    39.5%
    16
    35.6%
    26
    59.1%
    Week 4
    10
    23.3%
    14
    31.1%
    22
    51.2%
    24
    53.3%
    30
    68.2%
    19
    44.2%
    24
    53.3%
    26
    59.1%
    Week 5
    15
    34.9%
    17
    37.8%
    21
    48.8%
    26
    57.8%
    29
    65.9%
    22
    51.2%
    22
    48.9%
    25
    56.8%
    Week 6
    14
    32.6%
    18
    40%
    21
    48.8%
    27
    60%
    28
    63.6%
    19
    44.2%
    22
    48.9%
    26
    59.1%
    Week 7
    15
    34.9%
    19
    42.2%
    24
    55.8%
    25
    55.6%
    28
    63.6%
    20
    46.5%
    22
    48.9%
    25
    56.8%
    Week 8
    18
    41.9%
    19
    42.2%
    25
    58.1%
    24
    53.3%
    27
    61.4%
    19
    44.2%
    21
    46.7%
    26
    59.1%
    Week 9
    18
    41.9%
    21
    46.7%
    22
    51.2%
    27
    60%
    28
    63.6%
    19
    44.2%
    24
    53.3%
    26
    59.1%
    Week 10
    16
    37.2%
    21
    46.7%
    20
    46.5%
    23
    51.1%
    29
    65.9%
    21
    48.8%
    26
    57.8%
    24
    54.5%
    Week 11
    19
    44.2%
    25
    55.6%
    23
    53.5%
    24
    53.3%
    28
    63.6%
    20
    46.5%
    28
    62.2%
    28
    63.6%
    Week 12
    18
    41.9%
    21
    46.7%
    22
    51.2%
    25
    55.6%
    26
    59.1%
    22
    51.2%
    26
    57.8%
    27
    61.4%
    Week 13
    4
    9.3%
    12
    26.7%
    7
    16.3%
    9
    20%
    7
    15.9%
    10
    23.3%
    5
    11.1%
    11
    25%
    Week 14
    8
    18.6%
    6
    13.3%
    5
    11.6%
    3
    6.7%
    2
    4.5%
    7
    16.3%
    7
    15.6%
    10
    22.7%
    Week 15
    8
    18.6%
    4
    8.9%
    5
    11.6%
    3
    6.7%
    0
    0%
    2
    4.7%
    5
    11.1%
    7
    15.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1938
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.05
    Confidence Interval (2-Sided) 95%
    0.57 to 16.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0162
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.97
    Confidence Interval (2-Sided) 95%
    1.43 to 33.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.37
    Confidence Interval (2-Sided) 95%
    3.04 to 67.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 16.02
    Confidence Interval (2-Sided) 95%
    3.39 to 75.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1971
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.02
    Confidence Interval (2-Sided) 95%
    0.56 to 16.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0811
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.31
    Confidence Interval (2-Sided) 95%
    0.83 to 22.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.44
    Confidence Interval (2-Sided) 95%
    2.43 to 53.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1370
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.11
    Confidence Interval (2-Sided) 95%
    0.79 to 5.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0181
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.20
    Confidence Interval (2-Sided) 95%
    1.22 to 8.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.43
    Confidence Interval (2-Sided) 95%
    2.43 to 17.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.08
    Confidence Interval (2-Sided) 95%
    2.26 to 16.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3241
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.65
    Confidence Interval (2-Sided) 95%
    0.61 to 4.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2249
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.85
    Confidence Interval (2-Sided) 95%
    0.68 to 5.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0096
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.53
    Confidence Interval (2-Sided) 95%
    1.36 to 9.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0768
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.35
    Confidence Interval (2-Sided) 95%
    0.91 to 6.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.00251
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.91
    Confidence Interval (2-Sided) 95%
    1.14 to 7.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.99
    Confidence Interval (2-Sided) 95%
    2.30 to 15.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.29
    Confidence Interval (2-Sided) 95%
    2.70 to 19.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1144
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.14
    Confidence Interval (2-Sided) 95%
    0.83 to 5.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1341
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.80 to 5.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.43
    Confidence Interval (2-Sided) 95%
    1.75 to 11.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1488
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.77 to 5.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.99
    Confidence Interval (2-Sided) 95%
    1.54 to 10.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.53
    Confidence Interval (2-Sided) 95%
    2.10 to 14.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.54
    Confidence Interval (2-Sided) 95%
    4.85 to 43.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0262
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.96
    Confidence Interval (2-Sided) 95%
    1.14 to 7.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.07
    Confidence Interval (2-Sided) 95%
    1.95 to 13.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.33
    Confidence Interval (2-Sided) 95%
    2.06 to 13.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3673
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.52
    Confidence Interval (2-Sided) 95%
    0.61 to 3.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1207
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.02
    Confidence Interval (2-Sided) 95%
    0.83 to 4.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.01
    Confidence Interval (2-Sided) 95%
    1.90 to 13.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.19
    Confidence Interval (2-Sided) 95%
    3.08 to 27.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0594
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.38
    Confidence Interval (2-Sided) 95%
    0.97 to 5.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0500
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.47
    Confidence Interval (2-Sided) 95%
    1.00 to 6.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0123
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.22
    Confidence Interval (2-Sided) 95%
    1.29 to 8.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2243
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.76
    Confidence Interval (2-Sided) 95%
    0.71 to 4.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0976
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.13
    Confidence Interval (2-Sided) 95%
    0.87 to 5.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.09
    Confidence Interval (2-Sided) 95%
    2.25 to 16.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.13
    Confidence Interval (2-Sided) 95%
    3.04 to 27.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1237
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.82 to 5.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0226
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.94
    Confidence Interval (2-Sided) 95%
    1.16 to 7.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0069
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.55
    Confidence Interval (2-Sided) 95%
    1.42 to 8.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1666
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    0.76 to 4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0317
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    1.09 to 6.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.94 to 14.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.45
    Confidence Interval (2-Sided) 95%
    2.81 to 25.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1142
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.10
    Confidence Interval (2-Sided) 95%
    0.84 to 5.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0250
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.91
    Confidence Interval (2-Sided) 95%
    1.14 to 7.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0166
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.08
    Confidence Interval (2-Sided) 95%
    1.23 to 7.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6033
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.27
    Confidence Interval (2-Sided) 95%
    0.52 to 3.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1170
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.05
    Confidence Interval (2-Sided) 95%
    0.84 to 5.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0400
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.69
    Confidence Interval (2-Sided) 95%
    1.05 to 6.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.61
    Confidence Interval (2-Sided) 95%
    1.88 to 16.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5177
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.35
    Confidence Interval (2-Sided) 95%
    0.54 to 3.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2117
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.79
    Confidence Interval (2-Sided) 95%
    0.72 to 4.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0426
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    1.03 to 6.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3508
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.54
    Confidence Interval (2-Sided) 95%
    0.62 to 3.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4431
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.42
    Confidence Interval (2-Sided) 95%
    0.58 to 3.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0050
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.27
    Confidence Interval (2-Sided) 95%
    1.55 to 11.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.47
    Confidence Interval (2-Sided) 95%
    1.84 to 16.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5663
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.52 to 3.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0461
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    1.02 to 6.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0552
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.50
    Confidence Interval (2-Sided) 95%
    0.98 to 6.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1536
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.78 to 4.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2575
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.69
    Confidence Interval (2-Sided) 95%
    0.68 to 4.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0096
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.73
    Confidence Interval (2-Sided) 95%
    1.38 to 10.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.48
    Confidence Interval (2-Sided) 95%
    2.69 to 26.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1047
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.18
    Confidence Interval (2-Sided) 95%
    1.48 to 10.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.91
    Confidence Interval (2-Sided) 95%
    1.48 to 10.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0414
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    1.04 to 6.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0809
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.31
    Confidence Interval (2-Sided) 95%
    0.90 to 5.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2377
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.69 to 4.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0087
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.21
    Confidence Interval (2-Sided) 95%
    1.44 to 12.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.00
    Confidence Interval (2-Sided) 95%
    1.90 to 18.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4788
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.40
    Confidence Interval (2-Sided) 95%
    0.55 to 3.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0074
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.98
    Confidence Interval (2-Sided) 95%
    1.45 to 10.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0187
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.26
    Confidence Interval (2-Sided) 95%
    1.22 to 8.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3443
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.57
    Confidence Interval (2-Sided) 95%
    0.62 to 4.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2867
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.66
    Confidence Interval (2-Sided) 95%
    0.65 to 4.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.12
    Confidence Interval (2-Sided) 95%
    1.66 to 15.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0038
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.58
    Confidence Interval (2-Sided) 95%
    1.74 to 17.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1424
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.09
    Confidence Interval (2-Sided) 95%
    0.78 to 5.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0191
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    1.22 to 9.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0244
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.15
    Confidence Interval (2-Sided) 95%
    1.16 to 8.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1462
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.63
    Confidence Interval (2-Sided) 95%
    0.71 to 9.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7403
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.26
    Confidence Interval (2-Sided) 95%
    0.32 to 4.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2144
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.35
    Confidence Interval (2-Sided) 95%
    0.61 to 9.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4321
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.44 to 6.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1778
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    0.66 to 9.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.28 to 5.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1486
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    0.71 to 9.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2881
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.51
    Confidence Interval (2-Sided) 95%
    0.15 to 1.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1217
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.36
    Confidence Interval (2-Sided) 95%
    0.10 to 1.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.36
    Confidence Interval (2-Sided) 95%
    0.07 to 1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0428
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.18
    Confidence Interval (2-Sided) 95%
    0.03 to 0.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5943
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.72
    Confidence Interval (2-Sided) 95%
    0.21 to 2.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9280
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.27 to 3.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9160
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.30 to 2.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2262
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.43
    Confidence Interval (2-Sided) 95%
    0.11 to 1.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2682
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.48
    Confidence Interval (2-Sided) 95%
    0.13 to 1.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2344
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.40
    Confidence Interval (2-Sided) 95%
    0.09 to 1.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0835
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.22
    Confidence Interval (2-Sided) 95%
    0.04 to 1.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6322
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.72
    Confidence Interval (2-Sided) 95%
    0.19 to 2.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4845
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.65
    Confidence Interval (2-Sided) 95%
    0.20 to 2.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    1
    2.3%
    1
    2.2%
    1
    2.3%
    6
    13.3%
    6
    13.6%
    0
    0%
    3
    6.7%
    2
    4.5%
    Week 2
    2
    4.7%
    5
    11.1%
    6
    14%
    15
    33.3%
    16
    36.4%
    2
    4.7%
    5
    11.1%
    12
    27.3%
    Week 3
    4
    9.3%
    9
    20%
    9
    20.9%
    19
    42.2%
    16
    36.4%
    6
    14%
    9
    20%
    17
    38.6%
    Week 4
    6
    14%
    10
    22.2%
    12
    27.9%
    19
    42.2%
    17
    38.6%
    7
    16.3%
    12
    26.7%
    18
    40.9%
    Week 5
    6
    14%
    7
    15.6%
    11
    25.6%
    18
    40%
    20
    45.5%
    9
    20.9%
    10
    22.2%
    18
    40.9%
    Week 6
    9
    20.9%
    9
    20%
    16
    37.2%
    21
    46.7%
    23
    52.3%
    9
    20.9%
    9
    20%
    21
    47.7%
    Week 7
    6
    14%
    8
    17.8%
    15
    34.9%
    20
    44.4%
    24
    54.5%
    10
    23.3%
    12
    26.7%
    20
    45.5%
    Week 8
    13
    30.2%
    11
    24.4%
    17
    39.5%
    22
    48.9%
    23
    52.3%
    10
    23.3%
    14
    31.1%
    22
    50%
    Week 9
    13
    30.2%
    11
    24.4%
    15
    34.9%
    21
    46.7%
    25
    56.8%
    10
    23.3%
    14
    31.1%
    20
    45.5%
    Week 10
    13
    30.2%
    12
    26.7%
    14
    32.6%
    20
    44.4%
    26
    59.1%
    11
    25.6%
    15
    33.3%
    20
    45.5%
    Week 11
    14
    32.6%
    13
    28.9%
    13
    30.2%
    19
    42.2%
    25
    56.8%
    12
    27.9%
    18
    40%
    20
    45.5%
    Week 12
    13
    30.2%
    15
    33.3%
    15
    34.9%
    17
    37.8%
    22
    50%
    10
    23.3%
    16
    35.6%
    20
    45.5%
    Week 13
    1
    2.3%
    0
    0%
    1
    2.3%
    2
    4.4%
    1
    2.3%
    3
    7%
    1
    2.2%
    2
    4.5%
    Week 14
    1
    2.3%
    0
    0%
    2
    4.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.3%
    Week 15
    0
    0%
    0
    0%
    0
    0%
    1
    2.2%
    0
    0%
    0
    0%
    1
    2.2%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9587
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.06 to 17.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9895
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.06 to 16.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0736
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.24
    Confidence Interval (2-Sided) 95%
    0.83 to 63.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0767
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.08
    Confidence Interval (2-Sided) 95%
    0.81 to 61.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2880
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.51
    Confidence Interval (2-Sided) 95%
    0.35 to 35.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5894
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.96
    Confidence Interval (2-Sided) 95%
    0.17 to 22.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3093
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.45
    Confidence Interval (2-Sided) 95%
    0.44 to 13.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1606
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.31
    Confidence Interval (2-Sided) 95%
    0.62 to 17.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.92
    Confidence Interval (2-Sided) 95%
    2.50 to 56.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.40
    Confidence Interval (2-Sided) 95%
    3.02 to 68.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8803
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.86
    Confidence Interval (2-Sided) 95%
    0.11 to 6.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2096
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.98
    Confidence Interval (2-Sided) 95%
    0.54 to 16.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0110
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.69
    Confidence Interval (2-Sided) 95%
    1.60 to 37.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0845
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.09
    Confidence Interval (2-Sided) 95%
    0.86 to 11.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1094
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.83
    Confidence Interval (2-Sided) 95%
    0.79 to 10.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.97
    Confidence Interval (2-Sided) 95%
    2.68 to 30.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.11
    Confidence Interval (2-Sided) 95%
    2.10 to 24.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4375
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.44 to 6.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0898
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.02
    Confidence Interval (2-Sided) 95%
    0.84 to 10.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.32
    Confidence Interval (2-Sided) 95%
    1.90 to 21.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1242
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.44
    Confidence Interval (2-Sided) 95%
    0.78 to 7.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0815
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.66
    Confidence Interval (2-Sided) 95%
    0.88 to 8.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.21
    Confidence Interval (2-Sided) 95%
    2.11 to 18.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.78 to 15.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6267
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.35
    Confidence Interval (2-Sided) 95%
    0.41 to 4.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0709
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.77
    Confidence Interval (2-Sided) 95%
    0.92 to 8.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.62
    Confidence Interval (2-Sided) 95%
    1.59 to 13.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5107
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.50
    Confidence Interval (2-Sided) 95%
    0.45 to 4.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1297
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.78 to 7.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.04
    Confidence Interval (2-Sided) 95%
    2.34 to 21.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.50
    Confidence Interval (2-Sided) 95%
    2.82 to 25.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2990
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.84
    Confidence Interval (2-Sided) 95%
    0.58 to 5.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1355
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.38
    Confidence Interval (2-Sided) 95%
    0.76 to 7.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.17
    Confidence Interval (2-Sided) 95%
    1.76 to 15.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7422
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.20
    Confidence Interval (2-Sided) 95%
    0.41 to 3.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0750
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.44
    Confidence Interval (2-Sided) 95%
    0.91 to 6.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.00
    Confidence Interval (2-Sided) 95%
    2.16 to 16.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.63
    Confidence Interval (2-Sided) 95%
    2.69 to 21.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8405
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.12
    Confidence Interval (2-Sided) 95%
    0.38 to 3.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6257
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.30
    Confidence Interval (2-Sided) 95%
    0.45 to 3.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    1.48 to 10.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3556
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.54 to 5.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0190
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.67
    Confidence Interval (2-Sided) 95%
    1.24 to 10.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.90
    Confidence Interval (2-Sided) 95%
    3.20 to 30.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.81
    Confidence Interval (2-Sided) 95%
    4.67 to 47.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1936
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.13
    Confidence Interval (2-Sided) 95%
    0.68 to 6.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0335
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.39
    Confidence Interval (2-Sided) 95%
    1.10 to 10.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.18
    Confidence Interval (2-Sided) 95%
    2.10 to 18.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8330
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.34 to 2.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3410
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.56
    Confidence Interval (2-Sided) 95%
    0.62 to 3.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.71
    Confidence Interval (2-Sided) 95%
    1.42 to 9.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.86
    Confidence Interval (2-Sided) 95%
    1.78 to 13.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6216
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.29 to 2.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4615
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.43
    Confidence Interval (2-Sided) 95%
    0.55 to 3.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0281
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.84
    Confidence Interval (2-Sided) 95%
    1.12 to 7.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8028
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95%
    0.33 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6846
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.48 to 3.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0149
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.31
    Confidence Interval (2-Sided) 95%
    1.26 to 8.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.64
    Confidence Interval (2-Sided) 95%
    2.03 to 15.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6434
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    0.29 to 2.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4784
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.41
    Confidence Interval (2-Sided) 95%
    0.54 to 3.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0955
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    0.87 to 5.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9082
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.40 to 2.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6478
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    0.48 to 3.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0104
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.65
    Confidence Interval (2-Sided) 95%
    1.35 to 9.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.66
    Confidence Interval (2-Sided) 95%
    2.34 to 18.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8560
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.34 to 2.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3319
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.60
    Confidence Interval (2-Sided) 95%
    0.62 to 4.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0747
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.34
    Confidence Interval (2-Sided) 95%
    0.92 to 5.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8986
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.41 to 2.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9712
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 95%
    0.38 to 2.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0910
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.31
    Confidence Interval (2-Sided) 95%
    1.22 to 8.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.68
    Confidence Interval (2-Sided) 95%
    2.01 to 16.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8466
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.35 to 2.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1409
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.79 to 5.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1212
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.82 to 5.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4269
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.48
    Confidence Interval (2-Sided) 95%
    0.56 to 3.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5454
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.34
    Confidence Interval (2-Sided) 95%
    0.52 to 3.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0595
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    0.96 to 7.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0041
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.58
    Confidence Interval (2-Sided) 95%
    1.62 to 12.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6121
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.77
    Confidence Interval (2-Sided) 95%
    0.28 to 2.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2329
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.80
    Confidence Interval (2-Sided) 95%
    0.68 to 4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0891
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.28
    Confidence Interval (2-Sided) 95%
    0.88 to 5.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6857
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.55
    Confidence Interval (2-Sided) 95%
    0.03 to 9.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7291
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.56
    Confidence Interval (2-Sided) 95%
    0.12 to 19.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8951
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    0.05 to 14.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6865
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.66
    Confidence Interval (2-Sided) 95%
    0.14 to 19.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9132
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.17
    Confidence Interval (2-Sided) 95%
    0.07 to 20.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7982
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.38
    Confidence Interval (2-Sided) 95%
    0.12 to 16.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9029
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.17
    Confidence Interval (2-Sided) 95%
    0.09 to 15.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7971
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.69
    Confidence Interval (2-Sided) 95%
    0.04 to 11.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    1
    2.3%
    1
    2.2%
    0
    0%
    1
    2.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 2
    1
    2.3%
    2
    4.4%
    0
    0%
    5
    11.1%
    7
    15.9%
    0
    0%
    3
    6.7%
    4
    9.1%
    Week 3
    1
    2.3%
    3
    6.7%
    3
    7%
    9
    20%
    8
    18.2%
    2
    4.7%
    4
    8.9%
    9
    20.5%
    Week 4
    1
    2.3%
    2
    4.4%
    4
    9.3%
    6
    13.3%
    11
    25%
    3
    7%
    6
    13.3%
    8
    18.2%
    Week 5
    3
    7%
    2
    4.4%
    3
    7%
    10
    22.2%
    10
    22.7%
    3
    7%
    6
    13.3%
    6
    13.6%
    Week 6
    1
    2.3%
    6
    13.3%
    3
    7%
    11
    24.4%
    13
    29.5%
    3
    7%
    5
    11.1%
    12
    27.3%
    Week 7
    1
    2.3%
    5
    11.1%
    5
    11.6%
    13
    28.9%
    11
    25%
    6
    14%
    6
    13.3%
    14
    31.8%
    Week 8
    2
    4.7%
    7
    15.6%
    7
    16.3%
    15
    33.3%
    12
    27.3%
    5
    11.6%
    6
    13.3%
    14
    31.8%
    Week 9
    3
    7%
    7
    15.6%
    11
    25.6%
    12
    26.7%
    15
    34.1%
    3
    7%
    7
    15.6%
    12
    27.3%
    Week 10
    4
    9.3%
    7
    15.6%
    6
    14%
    9
    20%
    16
    36.4%
    3
    7%
    8
    17.8%
    15
    34.1%
    Week 11
    3
    7%
    7
    15.6%
    7
    16.3%
    13
    28.9%
    17
    38.6%
    7
    16.3%
    8
    17.8%
    13
    29.5%
    Week 12
    8
    18.6%
    7
    15.6%
    10
    23.3%
    11
    24.4%
    14
    31.8%
    5
    11.6%
    12
    26.7%
    10
    22.7%
    Week 13
    0
    0%
    0
    0%
    0
    0%
    1
    2.2%
    0
    0%
    0
    0%
    0
    0%
    1
    2.3%
    Week 14
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 15
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7899
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.67
    Confidence Interval (2-Sided) 95%
    0.04 to 12.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9186
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.86
    Confidence Interval (2-Sided) 95%
    0.05 to 14.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5303
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.19
    Confidence Interval (2-Sided) 95%
    0.19 to 25.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1149
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.85
    Confidence Interval (2-Sided) 95%
    0.65 to 52.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0442
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.07
    Confidence Interval (2-Sided) 95%
    1.06 to 77.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2851
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.53
    Confidence Interval (2-Sided) 95%
    0.35 to 35.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2073
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.22
    Confidence Interval (2-Sided) 95%
    0.45 to 39.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2700
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.68
    Confidence Interval (2-Sided) 95%
    0.36 to 37.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2982
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.41
    Confidence Interval (2-Sided) 95%
    0.34 to 34.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0204
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.30
    Confidence Interval (2-Sided) 95%
    1.47 to 102.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0270
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.10
    Confidence Interval (2-Sided) 95%
    1.31 to 93.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5224
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.19 to 25.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1635
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.92
    Confidence Interval (2-Sided) 95%
    0.52 to 46.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0266
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.97
    Confidence Interval (2-Sided) 95%
    1.32 to 91.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4299
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.69
    Confidence Interval (2-Sided) 95%
    0.23 to 31.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1667
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.87
    Confidence Interval (2-Sided) 95%
    0.52 to 45.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0592
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.11
    Confidence Interval (2-Sided) 95%
    0.92 to 71.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 18.28
    Confidence Interval (2-Sided) 95%
    2.21 to 151.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2594
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.79
    Confidence Interval (2-Sided) 95%
    0.37 to 38.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0589
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.14
    Confidence Interval (2-Sided) 95%
    0.92 to 71.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0338
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.08
    Confidence Interval (2-Sided) 95%
    1.19 to 85.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7756
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.76
    Confidence Interval (2-Sided) 95%
    0.12 to 4.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9246
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.20 to 5.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0177
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.42
    Confidence Interval (2-Sided) 95%
    1.34 to 21.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0178
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.38
    Confidence Interval (2-Sided) 95%
    1.34 to 21.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8564
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.17
    Confidence Interval (2-Sided) 95%
    0.22 to 6.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2202
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.52
    Confidence Interval (2-Sided) 95%
    0.58 to 11.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2498
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.55 to 10.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0576
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.22
    Confidence Interval (2-Sided) 95%
    0.93 to 72.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3065
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.34
    Confidence Interval (2-Sided) 95%
    0.33 to 33.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0056
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 19.90
    Confidence Interval (2-Sided) 95%
    2.40 to 165.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 25.05
    Confidence Interval (2-Sided) 95%
    3.05 to 205.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2762
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.61
    Confidence Interval (2-Sided) 95%
    0.36 to 36.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0851
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.93
    Confidence Interval (2-Sided) 95%
    0.77 to 62.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0081
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 17.02
    Confidence Interval (2-Sided) 95%
    2.09 to 138.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0995
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.37
    Confidence Interval (2-Sided) 95%
    0.70 to 57.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1184
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.76
    Confidence Interval (2-Sided) 95%
    0.64 to 51.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 26.54
    Confidence Interval (2-Sided) 95%
    3.23 to 218.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0062
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 19.09
    Confidence Interval (2-Sided) 95%
    2.31 to 157.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0695
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.49
    Confidence Interval (2-Sided) 95%
    0.85 to 65.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0520
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.64
    Confidence Interval (2-Sided) 95%
    0.98 to 75.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0036
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 22.30
    Confidence Interval (2-Sided) 95%
    2.75 to 180.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0676
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.66
    Confidence Interval (2-Sided) 95%
    0.89 to 24.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0903
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.14
    Confidence Interval (2-Sided) 95%
    0.80 to 21.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 15.46
    Confidence Interval (2-Sided) 95%
    3.18 to 75.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.94
    Confidence Interval (2-Sided) 95%
    2.22 to 53.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.04
    Confidence Interval (2-Sided) 95%
    0.55 to 16.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0972
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.13
    Confidence Interval (2-Sided) 95%
    0.77 to 22.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.04
    Confidence Interval (2-Sided) 95%
    2.30 to 53.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1306
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.06
    Confidence Interval (2-Sided) 95%
    0.72 to 13.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0248
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.83
    Confidence Interval (2-Sided) 95%
    1.22 to 19.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.14
    Confidence Interval (2-Sided) 95%
    1.79 to 28.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.01
    Confidence Interval (2-Sided) 95%
    2.55 to 39.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8271
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.23 to 6.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1089
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.27
    Confidence Interval (2-Sided) 95%
    0.77 to 13.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0138
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.58
    Confidence Interval (2-Sided) 95%
    1.42 to 21.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1987
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.40
    Confidence Interval (2-Sided) 95%
    0.63 to 9.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3984
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.80
    Confidence Interval (2-Sided) 95%
    0.46 to 7.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0402
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    1.06 to 14.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.05
    Confidence Interval (2-Sided) 95%
    2.32 to 27.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8287
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.84
    Confidence Interval (2-Sided) 95%
    0.17 to 4.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1083
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.93
    Confidence Interval (2-Sided) 95%
    0.79 to 10.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.03
    Confidence Interval (2-Sided) 95%
    1.76 to 20.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1126
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.23
    Confidence Interval (2-Sided) 95%
    0.76 to 13.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1479
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.90
    Confidence Interval (2-Sided) 95%
    0.69 to 12.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.49
    Confidence Interval (2-Sided) 95%
    2.59 to 42.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.01
    Confidence Interval (2-Sided) 95%
    3.31 to 51.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1483
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.91
    Confidence Interval (2-Sided) 95%
    0.68 to 12.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0557
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.03
    Confidence Interval (2-Sided) 95%
    0.97 to 16.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0072
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.47
    Confidence Interval (2-Sided) 95%
    1.66 to 25.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9715
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.32 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4720
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.49
    Confidence Interval (2-Sided) 95%
    0.50 to 4.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1262
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.35
    Confidence Interval (2-Sided) 95%
    0.79 to 7.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0396
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.07
    Confidence Interval (2-Sided) 95%
    1.05 to 8.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5137
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.66
    Confidence Interval (2-Sided) 95%
    0.19 to 2.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1370
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.25
    Confidence Interval (2-Sided) 95%
    0.77 to 6.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5526
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.39
    Confidence Interval (2-Sided) 95%
    0.47 to 4.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    6
    14%
    21
    46.7%
    25
    58.1%
    27
    60%
    28
    63.6%
    14
    32.6%
    23
    51.1%
    25
    56.8%
    Week 2
    15
    34.9%
    31
    68.9%
    31
    72.1%
    32
    71.1%
    32
    72.7%
    25
    58.1%
    29
    64.4%
    27
    61.4%
    Week 3
    18
    41.9%
    31
    68.9%
    31
    72.1%
    33
    73.3%
    33
    75%
    30
    69.8%
    33
    73.3%
    29
    65.9%
    Week 4
    23
    53.5%
    29
    64.4%
    31
    72.1%
    32
    71.1%
    32
    72.7%
    29
    67.4%
    32
    71.1%
    31
    70.5%
    Week 5
    23
    53.5%
    30
    66.7%
    34
    79.1%
    29
    64.4%
    31
    70.5%
    32
    74.4%
    35
    77.8%
    30
    68.2%
    Week 6
    25
    58.1%
    29
    64.4%
    31
    72.1%
    31
    68.9%
    30
    68.2%
    28
    65.1%
    34
    75.6%
    32
    72.7%
    Week 7
    26
    60.5%
    29
    64.4%
    33
    76.7%
    30
    66.7%
    30
    68.2%
    31
    72.1%
    32
    71.1%
    29
    65.9%
    Week 8
    28
    65.1%
    31
    68.9%
    33
    76.7%
    32
    71.1%
    28
    63.6%
    30
    69.8%
    33
    73.3%
    32
    72.7%
    Week 9
    27
    62.8%
    30
    66.7%
    33
    76.7%
    32
    71.1%
    31
    70.5%
    28
    65.1%
    32
    71.1%
    29
    65.9%
    Week 10
    25
    58.1%
    31
    68.9%
    29
    67.4%
    26
    57.8%
    31
    70.5%
    29
    67.4%
    35
    77.8%
    31
    70.5%
    Week 11
    25
    58.1%
    31
    68.9%
    31
    72.1%
    25
    55.6%
    30
    68.2%
    31
    72.1%
    34
    75.6%
    31
    70.5%
    Week 12
    22
    51.2%
    31
    68.9%
    29
    67.4%
    27
    60%
    29
    65.9%
    26
    60.5%
    32
    71.1%
    31
    70.5%
    Week 13
    12
    27.9%
    22
    48.9%
    18
    41.9%
    14
    31.1%
    18
    40.9%
    19
    44.2%
    16
    35.6%
    16
    36.4%
    Week 14
    11
    25.6%
    19
    42.2%
    16
    37.2%
    9
    20%
    14
    31.8%
    18
    41.9%
    14
    31.1%
    18
    40.9%
    Week 15
    13
    30.2%
    12
    26.7%
    12
    27.9%
    8
    17.8%
    12
    27.3%
    14
    32.6%
    12
    26.7%
    13
    29.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.75
    Confidence Interval (2-Sided) 95%
    1.99 to 16.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.86
    Confidence Interval (2-Sided) 95%
    3.06 to 25.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.55
    Confidence Interval (2-Sided) 95%
    3.94 to 33.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.55
    Confidence Interval (2-Sided) 95%
    4.55 to 40.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0555
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.90
    Confidence Interval (2-Sided) 95%
    0.98 to 8.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.98
    Confidence Interval (2-Sided) 95%
    2.75 to 23.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.07
    Confidence Interval (2-Sided) 95%
    2.81 to 23.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.55
    Confidence Interval (2-Sided) 95%
    1.82 to 11.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.25
    Confidence Interval (2-Sided) 95%
    2.06 to 13.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.62
    Confidence Interval (2-Sided) 95%
    2.20 to 14.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.42
    Confidence Interval (2-Sided) 95%
    2.99 to 23.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0277
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.74
    Confidence Interval (2-Sided) 95%
    1.12 to 6.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.15
    Confidence Interval (2-Sided) 95%
    1.66 to 10.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0314
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.06
    Confidence Interval (2-Sided) 95%
    1.26 to 7.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0041
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    1.54 to 9.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.19
    Confidence Interval (2-Sided) 95%
    1.64 to 10.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.96
    Confidence Interval (2-Sided) 95%
    1.90 to 12.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.79
    Confidence Interval (2-Sided) 95%
    2.86 to 26.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0036
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.09
    Confidence Interval (2-Sided) 95%
    1.59 to 10.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.52
    Confidence Interval (2-Sided) 95%
    1.75 to 11.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0243
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.76
    Confidence Interval (2-Sided) 95%
    1.14 to 6.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0770
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.33
    Confidence Interval (2-Sided) 95%
    0.91 to 5.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0451
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.61
    Confidence Interval (2-Sided) 95%
    1.02 to 6.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0165
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.36
    Confidence Interval (2-Sided) 95%
    1.25 to 9.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.72 to 16.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0812
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.90 to 5.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0577
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.46
    Confidence Interval (2-Sided) 95%
    0.97 to 6.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0706
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.33
    Confidence Interval (2-Sided) 95%
    0.93 to 5.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0404
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    1.04 to 7.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.30
    Confidence Interval (2-Sided) 95%
    1.54 to 11.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0186
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.37
    Confidence Interval (2-Sided) 95%
    1.22 to 9.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.58
    Confidence Interval (2-Sided) 95%
    1.96 to 22.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0118
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.63
    Confidence Interval (2-Sided) 95%
    1.33 to 9.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.57
    Confidence Interval (2-Sided) 95%
    1.88 to 16.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0430
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.71
    Confidence Interval (2-Sided) 95%
    1.03 to 7.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2197
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.81
    Confidence Interval (2-Sided) 95%
    0.70 to 4.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1341
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.80 to 5.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0196
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.69
    Confidence Interval (2-Sided) 95%
    1.23 to 11.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0121
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.79
    Confidence Interval (2-Sided) 95%
    1.41 to 16.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1511
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.77 to 5.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0068
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.94
    Confidence Interval (2-Sided) 95%
    1.55 to 15.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0741
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.49
    Confidence Interval (2-Sided) 95%
    0.91 to 6.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2772
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.70
    Confidence Interval (2-Sided) 95%
    0.65 to 4.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0705
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.92 to 7.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0220
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.88
    Confidence Interval (2-Sided) 95%
    1.22 to 12.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0196
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.33
    Confidence Interval (2-Sided) 95%
    1.27 to 14.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0433
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.09
    Confidence Interval (2-Sided) 95%
    1.03 to 9.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0355
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.15
    Confidence Interval (2-Sided) 95%
    1.08 to 9.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3238
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.62 to 4.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3208
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.68
    Confidence Interval (2-Sided) 95%
    0.60 to 4.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2281
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    0.67 to 5.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0566
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.18
    Confidence Interval (2-Sided) 95%
    0.97 to 10.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1491
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.39
    Confidence Interval (2-Sided) 95%
    0.73 to 7.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1477
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.32
    Confidence Interval (2-Sided) 95%
    0.74 to 7.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0532
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.24
    Confidence Interval (2-Sided) 95%
    0.98 to 10.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1616
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.73 to 6.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4320
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.50
    Confidence Interval (2-Sided) 95%
    0.55 to 4.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2231
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    0.68 to 5.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0347
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.88
    Confidence Interval (2-Sided) 95%
    1.10 to 13.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0291
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.59
    Confidence Interval (2-Sided) 95%
    1.17 to 18.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2805
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.82
    Confidence Interval (2-Sided) 95%
    0.61 to 5.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0602
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.10
    Confidence Interval (2-Sided) 95%
    0.95 to 10.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5087
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.41
    Confidence Interval (2-Sided) 95%
    0.51 to 3.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1224
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.80 to 6.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2280
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.85
    Confidence Interval (2-Sided) 95%
    0.68 to 5.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1835
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.07
    Confidence Interval (2-Sided) 95%
    0.71 to 6.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0107
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.85
    Confidence Interval (2-Sided) 95%
    1.51 to 22.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0576
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.94
    Confidence Interval (2-Sided) 95%
    0.97 to 8.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0047
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.68
    Confidence Interval (2-Sided) 95%
    2.00 to 46.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0569
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.89
    Confidence Interval (2-Sided) 95%
    0.97 to 8.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1078
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.35
    Confidence Interval (2-Sided) 95%
    0.83 to 6.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0772
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    0.90 to 7.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1311
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.36
    Confidence Interval (2-Sided) 95%
    0.77 to 7.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.01255
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.64
    Confidence Interval (2-Sided) 95%
    1.45 to 21.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0128
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.97
    Confidence Interval (2-Sided) 95%
    1.41 to 17.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0079
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.32
    Confidence Interval (2-Sided) 95%
    1.62 to 24.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0572
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.90
    Confidence Interval (2-Sided) 95%
    0.97 to 8.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0284
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.33
    Confidence Interval (2-Sided) 95%
    1.14 to 9.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0705
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.58
    Confidence Interval (2-Sided) 95%
    0.92 to 7.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0136
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.81
    Confidence Interval (2-Sided) 95%
    1.38 to 16.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.96
    Confidence Interval (2-Sided) 95%
    2.06 to 48.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0760
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.66
    Confidence Interval (2-Sided) 95%
    0.90 to 7.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.75
    Confidence Interval (2-Sided) 95%
    1.65 to 20.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0143
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.22
    Confidence Interval (2-Sided) 95%
    1.33 to 13.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2779
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.82
    Confidence Interval (2-Sided) 95%
    0.62 to 5.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7559
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    0.41 to 3.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9050
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    0.35 to 3.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2163
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.05
    Confidence Interval (2-Sided) 95%
    0.66 to 6.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1713
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.24
    Confidence Interval (2-Sided) 95%
    0.70 to 7.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3981
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.52 to 5.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9692
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.35 to 2.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2978
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.77
    Confidence Interval (2-Sided) 95%
    0.60 to 5.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8525
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.38 to 3.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5028
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.67
    Confidence Interval (2-Sided) 95%
    0.21 to 2.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4594
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.53
    Confidence Interval (2-Sided) 95%
    0.50 to 4.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1124
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.56
    Confidence Interval (2-Sided) 95%
    0.80 to 8.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3415
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    0.55 to 5.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3635
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.65
    Confidence Interval (2-Sided) 95%
    0.56 to 4.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5716
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.73
    Confidence Interval (2-Sided) 95%
    0.24 to 2.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5028
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.69
    Confidence Interval (2-Sided) 95%
    0.23 to 2.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3982
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.60
    Confidence Interval (2-Sided) 95%
    0.18 to 1.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.93
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.93
    Confidence Interval (2-Sided) 95%
    0.30 to 2.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2364
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.12
    Confidence Interval (2-Sided) 95%
    0.61 to 7.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7095
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    0.39 to 4.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.26 to 2.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    2
    4.7%
    11
    24.4%
    14
    32.6%
    21
    46.7%
    22
    50%
    6
    14%
    11
    24.4%
    17
    38.6%
    Week 2
    9
    20.9%
    18
    40%
    25
    58.1%
    27
    60%
    25
    56.8%
    15
    34.9%
    20
    44.4%
    22
    50%
    Week 3
    11
    25.6%
    22
    48.9%
    27
    62.8%
    28
    62.2%
    28
    63.6%
    21
    48.8%
    24
    53.3%
    25
    56.8%
    Week 4
    13
    30.2%
    20
    44.4%
    29
    67.4%
    25
    55.6%
    30
    68.2%
    25
    58.1%
    28
    62.2%
    25
    56.8%
    Week 5
    16
    37.2%
    20
    44.4%
    30
    69.8%
    25
    55.6%
    29
    65.9%
    25
    58.1%
    28
    62.2%
    26
    59.1%
    Week 6
    18
    41.9%
    21
    46.7%
    29
    67.4%
    27
    60%
    28
    63.6%
    23
    53.5%
    30
    66.7%
    26
    59.1%
    Week 7
    18
    41.9%
    23
    51.1%
    32
    74.4%
    25
    55.6%
    28
    63.6%
    25
    58.1%
    28
    62.2%
    25
    56.8%
    Week 8
    19
    44.2%
    26
    57.8%
    31
    72.1%
    26
    57.8%
    28
    63.6%
    21
    48.8%
    26
    57.8%
    26
    59.1%
    Week 9
    21
    48.8%
    26
    57.8%
    29
    67.4%
    27
    60%
    29
    65.9%
    25
    58.1%
    28
    62.2%
    26
    59.1%
    Week 10
    18
    41.9%
    26
    57.8%
    28
    65.1%
    23
    51.1%
    29
    65.9%
    23
    53.5%
    29
    64.4%
    25
    56.8%
    Week 11
    21
    48.8%
    27
    60%
    30
    69.8%
    24
    53.3%
    28
    63.6%
    26
    60.5%
    30
    66.7%
    28
    63.6%
    Week 12
    20
    46.5%
    24
    53.3%
    27
    62.8%
    24
    53.3%
    27
    61.4%
    25
    58.1%
    28
    62.2%
    26
    59.1%
    Week 13
    5
    11.6%
    17
    37.8%
    9
    20.9%
    11
    24.4%
    8
    18.2%
    15
    34.9%
    7
    15.6%
    12
    27.3%
    Week 14
    9
    20.9%
    10
    22.2%
    8
    18.6%
    7
    15.6%
    3
    6.8%
    10
    23.3%
    7
    15.6%
    10
    22.7%
    Week 15
    7
    16.3%
    9
    20%
    8
    18.6%
    4
    8.9%
    1
    2.3%
    8
    18.6%
    7
    15.6%
    8
    18.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0181
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.78
    Confidence Interval (2-Sided) 95%
    1.39 to 33.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0039
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.97
    Confidence Interval (2-Sided) 95%
    2.10 to 47.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 21.20
    Confidence Interval (2-Sided) 95%
    4.51 to 99.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 23.97
    Confidence Interval (2-Sided) 95%
    5.09 to 112.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1766
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.17
    Confidence Interval (2-Sided) 95%
    0.59 to 16.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0116
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.68
    Confidence Interval (2-Sided) 95%
    1.58 to 37.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.74
    Confidence Interval (2-Sided) 95%
    2.71 to 59.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0359
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    1.07 to 7.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.80
    Confidence Interval (2-Sided) 95%
    2.20 to 15.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.13
    Confidence Interval (2-Sided) 95%
    2.68 to 18.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.84
    Confidence Interval (2-Sided) 95%
    2.53 to 18.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1540
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.04
    Confidence Interval (2-Sided) 95%
    0.76 to 5.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0065
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.84
    Confidence Interval (2-Sided) 95%
    1.46 to 10.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0052
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.90
    Confidence Interval (2-Sided) 95%
    1.50 to 10.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.68
    Confidence Interval (2-Sided) 95%
    1.44 to 9.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.86
    Confidence Interval (2-Sided) 95%
    2.26 to 15.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.42
    Confidence Interval (2-Sided) 95%
    2.47 to 16.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.21
    Confidence Interval (2-Sided) 95%
    3.01 to 22.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0171
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.12
    Confidence Interval (2-Sided) 95%
    1.22 to 7.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.38
    Confidence Interval (2-Sided) 95%
    1.71 to 11.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.97
    Confidence Interval (2-Sided) 95%
    1.58 to 9.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0399
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.63
    Confidence Interval (2-Sided) 95%
    1.05 to 6.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.76
    Confidence Interval (2-Sided) 95%
    2.23 to 14.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.05
    Confidence Interval (2-Sided) 95%
    1.60 to 10.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.82
    Confidence Interval (2-Sided) 95%
    3.41 to 28.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0036
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.96
    Confidence Interval (2-Sided) 95%
    1.57 to 10.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.79
    Confidence Interval (2-Sided) 95%
    1.89 to 12.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0091
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.33
    Confidence Interval (2-Sided) 95%
    1.35 to 8.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2043
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.78
    Confidence Interval (2-Sided) 95%
    0.73 to 4.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.70
    Confidence Interval (2-Sided) 95%
    1.84 to 12.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.77
    Confidence Interval (2-Sided) 95%
    1.47 to 9.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.07
    Confidence Interval (2-Sided) 95%
    2.73 to 23.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0221
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.88
    Confidence Interval (2-Sided) 95%
    1.16 to 7.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.00
    Confidence Interval (2-Sided) 95%
    1.58 to 10.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0123
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.22
    Confidence Interval (2-Sided) 95%
    1.29 to 8.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3291
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.56
    Confidence Interval (2-Sided) 95%
    0.64 to 3.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0118
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.27
    Confidence Interval (2-Sided) 95%
    1.30 to 8.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.93
    Confidence Interval (2-Sided) 95%
    1.49 to 10.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.98
    Confidence Interval (2-Sided) 95%
    2.03 to 17.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1043
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.13
    Confidence Interval (2-Sided) 95%
    0.85 to 5.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.01
    Confidence Interval (2-Sided) 95%
    1.85 to 13.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0658
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.33
    Confidence Interval (2-Sided) 95%
    0.95 to 5.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1253
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.02
    Confidence Interval (2-Sided) 95%
    0.82 to 4.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.01
    Confidence Interval (2-Sided) 95%
    1.88 to 13.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0096
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.66
    Confidence Interval (2-Sided) 95%
    1.37 to 9.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.06
    Confidence Interval (2-Sided) 95%
    2.04 to 17.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0344
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.75
    Confidence Interval (2-Sided) 95%
    1.08 to 7.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.07
    Confidence Interval (2-Sided) 95%
    1.55 to 10.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0810
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.24
    Confidence Interval (2-Sided) 95%
    0.91 to 5.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0761
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.92 to 5.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0078
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.66
    Confidence Interval (2-Sided) 95%
    1.41 to 9.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0253
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.99
    Confidence Interval (2-Sided) 95%
    1.15 to 7.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.23
    Confidence Interval (2-Sided) 95%
    1.99 to 19.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3512
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.55
    Confidence Interval (2-Sided) 95%
    0.62 to 3.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0352
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.77
    Confidence Interval (2-Sided) 95%
    1.07 to 7.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0704
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.36
    Confidence Interval (2-Sided) 95%
    0.93 to 5.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1651
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.94
    Confidence Interval (2-Sided) 95%
    0.76 to 4.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0964
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.21
    Confidence Interval (2-Sided) 95%
    0.87 to 5.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0276
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.12
    Confidence Interval (2-Sided) 95%
    1.13 to 8.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.99
    Confidence Interval (2-Sided) 95%
    1.58 to 15.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1556
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.76 to 5.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0202
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.33
    Confidence Interval (2-Sided) 95%
    1.21 to 9.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2063
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.72 to 4.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0383
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    1.06 to 6.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0118
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.46
    Confidence Interval (2-Sided) 95%
    1.32 to 9.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0314
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.96
    Confidence Interval (2-Sided) 95%
    1.10 to 7.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.80
    Confidence Interval (2-Sided) 95%
    2.17 to 21.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0956
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.24
    Confidence Interval (2-Sided) 95%
    0.87 to 5.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.80
    Confidence Interval (2-Sided) 95%
    1.72 to 13.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0660
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.94 to 6.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0853
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.32
    Confidence Interval (2-Sided) 95%
    0.89 to 6.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0159
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.49
    Confidence Interval (2-Sided) 95%
    1.26 to 9.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0303
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.27
    Confidence Interval (2-Sided) 95%
    1.12 to 9.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0071
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.84
    Confidence Interval (2-Sided) 95%
    1.54 to 15.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0621
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    0.95 to 7.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0081
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.20
    Confidence Interval (2-Sided) 95%
    1.45 to 12.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0533
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    0.99 to 7.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2666
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.66 to 4.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0754
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.44
    Confidence Interval (2-Sided) 95%
    0.91 to 6.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0313
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.27
    Confidence Interval (2-Sided) 95%
    1.11 to 9.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0056
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.76
    Confidence Interval (2-Sided) 95%
    1.67 to 19.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0736
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.58
    Confidence Interval (2-Sided) 95%
    0.91 to 7.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0184
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.51
    Confidence Interval (2-Sided) 95%
    1.24 to 10.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1187
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.18
    Confidence Interval (2-Sided) 95%
    0.82 to 5.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0299
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.80
    Confidence Interval (2-Sided) 95%
    1.14 to 12.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5989
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.40
    Confidence Interval (2-Sided) 95%
    0.40 to 4.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1337
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.61
    Confidence Interval (2-Sided) 95%
    0.74 to 9.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4605
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.62
    Confidence Interval (2-Sided) 95%
    0.45 to 5.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0188
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.48
    Confidence Interval (2-Sided) 95%
    1.28 to 15.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5854
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.44
    Confidence Interval (2-Sided) 95%
    0.39 to 5.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1768
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.32
    Confidence Interval (2-Sided) 95%
    0.68 to 7.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8426
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.89
    Confidence Interval (2-Sided) 95%
    0.29 to 2.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3017
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.54
    Confidence Interval (2-Sided) 95%
    0.17 to 1.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5958
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.72
    Confidence Interval (2-Sided) 95%
    0.21 to 2.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0515
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.23
    Confidence Interval (2-Sided) 95%
    0.05 to 1.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9734
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 95%
    0.31 to 3.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7969
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.85
    Confidence Interval (2-Sided) 95%
    0.25 to 2.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6637
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.25 to 2.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4921
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.53
    Confidence Interval (2-Sided) 95%
    0.45 to 5.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8910
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.33 to 3.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5881
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.68
    Confidence Interval (2-Sided) 95%
    0.16 to 2.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0523
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.11
    Confidence Interval (2-Sided) 95%
    0.01 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4646
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.60
    Confidence Interval (2-Sided) 95%
    0.46 to 5.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5806
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.43
    Confidence Interval (2-Sided) 95%
    0.40 to 5.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9220
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.28 to 3.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    1
    2.3%
    4
    8.9%
    5
    11.6%
    10
    22.2%
    12
    27.3%
    2
    4.7%
    4
    8.9%
    6
    13.6%
    Week 2
    3
    7%
    8
    17.8%
    13
    30.2%
    18
    40%
    21
    47.7%
    7
    16.3%
    7
    15.6%
    14
    31.8%
    Week 3
    5
    11.6%
    12
    26.7%
    15
    34.9%
    23
    51.1%
    23
    52.3%
    9
    20.9%
    14
    31.1%
    18
    40.9%
    Week 4
    8
    18.6%
    12
    26.7%
    18
    41.9%
    23
    51.1%
    22
    50%
    12
    27.9%
    14
    31.1%
    18
    40.9%
    Week 5
    8
    18.6%
    12
    26.7%
    18
    41.9%
    20
    44.4%
    24
    54.5%
    13
    30.2%
    13
    28.9%
    19
    43.2%
    Week 6
    10
    23.3%
    13
    28.9%
    21
    48.8%
    22
    48.9%
    25
    56.8%
    12
    27.9%
    14
    31.1%
    21
    47.7%
    Week 7
    9
    20.9%
    12
    26.7%
    22
    51.2%
    21
    46.7%
    26
    59.1%
    12
    27.9%
    17
    37.8%
    21
    47.7%
    Week 8
    14
    32.6%
    17
    37.8%
    22
    51.2%
    22
    48.9%
    27
    61.4%
    12
    27.9%
    19
    42.2%
    22
    50%
    Week 9
    16
    37.2%
    17
    37.8%
    22
    51.2%
    24
    53.3%
    27
    61.4%
    12
    27.9%
    20
    44.4%
    21
    47.7%
    Week 10
    14
    32.6%
    18
    40%
    19
    44.2%
    20
    44.4%
    28
    63.6%
    16
    37.2%
    18
    40%
    22
    50%
    Week 11
    15
    34.9%
    18
    40%
    20
    46.5%
    20
    44.4%
    26
    59.1%
    16
    37.2%
    21
    46.7%
    21
    47.7%
    Week 12
    14
    32.6%
    18
    40%
    19
    44.2%
    18
    40%
    24
    54.5%
    16
    37.2%
    19
    42.2%
    22
    50%
    Week 13
    1
    2.3%
    5
    11.1%
    3
    7%
    9
    20%
    2
    4.5%
    8
    18.6%
    3
    6.7%
    2
    4.5%
    Week 14
    1
    2.3%
    4
    8.9%
    3
    7%
    4
    8.9%
    1
    2.3%
    5
    11.6%
    3
    6.7%
    1
    2.3%
    Week 15
    0
    0%
    2
    4.4%
    3
    7%
    3
    6.7%
    0
    0%
    1
    2.3%
    4
    8.9%
    1
    2.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1933
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.45
    Confidence Interval (2-Sided) 95%
    0.47 to 42.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1240
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.61
    Confidence Interval (2-Sided) 95%
    0.62 to 50.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0140
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.16
    Confidence Interval (2-Sided) 95%
    1.71 to 117.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 17.50
    Confidence Interval (2-Sided) 95%
    2.15 to 142.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5853
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.98
    Confidence Interval (2-Sided) 95%
    0.17 to 22.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1596
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.00
    Confidence Interval (2-Sided) 95%
    0.53 to 47.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0908
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.48
    Confidence Interval (2-Sided) 95%
    0.74 to 56.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1318
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.97
    Confidence Interval (2-Sided) 95%
    0.72 to 12.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0093
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.99
    Confidence Interval (2-Sided) 95%
    1.56 to 23.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.13
    Confidence Interval (2-Sided) 95%
    2.69 to 38.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 15.63
    Confidence Interval (2-Sided) 95%
    4.11 to 59.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2054
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    0.60 to 10.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1592
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.80
    Confidence Interval (2-Sided) 95%
    0.67 to 11.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.31
    Confidence Interval (2-Sided) 95%
    1.66 to 24.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0392
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.39
    Confidence Interval (2-Sided) 95%
    1.06 to 10.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0096
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.49
    Confidence Interval (2-Sided) 95%
    1.44 to 13.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.11
    Confidence Interval (2-Sided) 95%
    3.28 to 31.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.76
    Confidence Interval (2-Sided) 95%
    3.75 to 36.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2217
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.11
    Confidence Interval (2-Sided) 95%
    0.64 to 7.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0131
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.26
    Confidence Interval (2-Sided) 95%
    1.36 to 13.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.39
    Confidence Interval (2-Sided) 95%
    1.76 to 16.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1485
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.15
    Confidence Interval (2-Sided) 95%
    0.76 to 6.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0128
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.54
    Confidence Interval (2-Sided) 95%
    1.31 to 9.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.50
    Confidence Interval (2-Sided) 95%
    2.37 to 17.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.42
    Confidence Interval (2-Sided) 95%
    2.32 to 17.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2354
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.87
    Confidence Interval (2-Sided) 95%
    0.67 to 5.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0894
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.87 to 6.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0201
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.23
    Confidence Interval (2-Sided) 95%
    1.20 to 8.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1614
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.10
    Confidence Interval (2-Sided) 95%
    0.74 to 5.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0123
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.57
    Confidence Interval (2-Sided) 95%
    1.32 to 9.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.08
    Confidence Interval (2-Sided) 95%
    2.17 to 17.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.82
    Confidence Interval (2-Sided) 95%
    3.40 to 28.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1609
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.75 to 5.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0930
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.42
    Confidence Interval (2-Sided) 95%
    0.86 to 6.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.02
    Confidence Interval (2-Sided) 95%
    1.48 to 10.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2621
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.76
    Confidence Interval (2-Sided) 95%
    0.65 to 4.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0092
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.55
    Confidence Interval (2-Sided) 95%
    1.37 to 9.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.69
    Confidence Interval (2-Sided) 95%
    2.09 to 15.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.85
    Confidence Interval (2-Sided) 95%
    3.08 to 25.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4259
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.50
    Confidence Interval (2-Sided) 95%
    0.55 to 4.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1334
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.13
    Confidence Interval (2-Sided) 95%
    0.79 to 5.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0120
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.39
    Confidence Interval (2-Sided) 95%
    1.31 to 8.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2443
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.84
    Confidence Interval (2-Sided) 95%
    0.66 to 5.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.60
    Confidence Interval (2-Sided) 95%
    1.73 to 12.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.60
    Confidence Interval (2-Sided) 95%
    2.35 to 18.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.17
    Confidence Interval (2-Sided) 95%
    4.05 to 36.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3101
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.70
    Confidence Interval (2-Sided) 95%
    0.61 to 4.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0116
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.65
    Confidence Interval (2-Sided) 95%
    1.34 to 10.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.15
    Confidence Interval (2-Sided) 95%
    1.56 to 11.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3505
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.55
    Confidence Interval (2-Sided) 95%
    0.62 to 3.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0739
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.28
    Confidence Interval (2-Sided) 95%
    0.92 to 5.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0163
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.19
    Confidence Interval (2-Sided) 95%
    1.24 to 8.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.49
    Confidence Interval (2-Sided) 95%
    2.81 to 25.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8358
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.35 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.18
    Confidence Interval (2-Sided) 95%
    0.86 to 5.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0484
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    1.01 to 6.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6492
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.24
    Confidence Interval (2-Sided) 95%
    0.50 to 3.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2230
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.71 to 4.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0126
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.43
    Confidence Interval (2-Sided) 95%
    1.30 to 9.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.56
    Confidence Interval (2-Sided) 95%
    1.94 to 15.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4713
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.70
    Confidence Interval (2-Sided) 95%
    0.27 to 1.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1397
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.02
    Confidence Interval (2-Sided) 95%
    0.79 to 5.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2272
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    0.71 to 4.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2024
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.72 to 4.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1716
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    0.76 to 4.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.20
    Confidence Interval (2-Sided) 95%
    1.20 to 8.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.45
    Confidence Interval (2-Sided) 95%
    2.80 to 25.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4243
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.57 to 3.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1507
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.99
    Confidence Interval (2-Sided) 95%
    0.78 to 5.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0449
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    1.02 to 6.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2759
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.68
    Confidence Interval (2-Sided) 95%
    0.66 to 4.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1700
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    0.76 to 4.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0153
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.47
    Confidence Interval (2-Sided) 95%
    1.27 to 9.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.04
    Confidence Interval (2-Sided) 95%
    2.08 to 17.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6228
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.27
    Confidence Interval (2-Sided) 95%
    0.50 to 3.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0460
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    1.02 to 6.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1215
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.07
    Confidence Interval (2-Sided) 95%
    0.82 to 5.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2470
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    0.68 to 4.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2072
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.72 to 4.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0621
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.57
    Confidence Interval (2-Sided) 95%
    0.95 to 6.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.67
    Confidence Interval (2-Sided) 95%
    1.93 to 16.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4372
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.56 to 3.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1100
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.18
    Confidence Interval (2-Sided) 95%
    0.84 to 5.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0533
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.99 to 6.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1769
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.68
    Confidence Interval (2-Sided) 95%
    0.50 to 44.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4942
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.22 to 23.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0214
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.82
    Confidence Interval (2-Sided) 95%
    1.46 to 112.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6013
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.93
    Confidence Interval (2-Sided) 95%
    0.16 to 22.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0537
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.60
    Confidence Interval (2-Sided) 95%
    0.97 to 76.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2662
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.80
    Confidence Interval (2-Sided) 95%
    0.36 to 39.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7431
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.51
    Confidence Interval (2-Sided) 95%
    0.13 to 17.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2829
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.53
    Confidence Interval (2-Sided) 95%
    0.35 to 35.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5311
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.12
    Confidence Interval (2-Sided) 95%
    0.20 to 22.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1857
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.71
    Confidence Interval (2-Sided) 95%
    0.47 to 46.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9879
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.06 to 17.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1853
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.57
    Confidence Interval (2-Sided) 95%
    0.48 to 43.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2170
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.43
    Confidence Interval (2-Sided) 95%
    0.42 to 46.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8354
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.04 to 12.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    20. Secondary Outcome
    Title Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    1
    2.3%
    1
    2.2%
    0
    0%
    3
    6.7%
    3
    6.8%
    0
    0%
    1
    2.2%
    0
    0%
    Week 2
    1
    2.3%
    2
    4.4%
    3
    7%
    7
    15.6%
    10
    22.7%
    0
    0%
    4
    8.9%
    6
    13.6%
    Week 3
    1
    2.3%
    5
    11.1%
    6
    14%
    9
    20%
    12
    27.3%
    4
    9.3%
    6
    13.3%
    12
    27.3%
    Week 4
    1
    2.3%
    3
    6.7%
    8
    18.6%
    10
    22.2%
    14
    31.8%
    4
    9.3%
    8
    17.8%
    9
    20.5%
    Week 5
    4
    9.3%
    5
    11.1%
    8
    18.6%
    10
    22.2%
    15
    34.1%
    6
    14%
    7
    15.6%
    8
    18.2%
    Week 6
    1
    2.3%
    8
    17.8%
    10
    23.3%
    12
    26.7%
    16
    36.4%
    5
    11.6%
    6
    13.3%
    15
    34.1%
    Week 7
    1
    2.3%
    7
    15.6%
    10
    23.3%
    14
    31.1%
    16
    36.4%
    9
    20.9%
    10
    22.2%
    15
    34.1%
    Week 8
    4
    9.3%
    9
    20%
    12
    27.9%
    16
    35.6%
    16
    36.4%
    6
    14%
    9
    20%
    15
    34.1%
    Week 9
    5
    11.6%
    9
    20%
    12
    27.9%
    15
    33.3%
    18
    40.9%
    5
    11.6%
    12
    26.7%
    15
    34.1%
    Week 10
    7
    16.3%
    9
    20%
    11
    25.6%
    16
    35.6%
    19
    43.2%
    6
    14%
    9
    20%
    17
    38.6%
    Week 11
    5
    11.6%
    9
    20%
    11
    25.6%
    15
    33.3%
    19
    43.2%
    10
    23.3%
    9
    20%
    15
    34.1%
    Week 12
    9
    20.9%
    8
    17.8%
    12
    27.9%
    14
    31.1%
    16
    36.4%
    9
    20.9%
    14
    31.1%
    13
    29.5%
    Week 13
    0
    0%
    1
    2.2%
    2
    4.7%
    6
    13.3%
    1
    2.3%
    3
    7%
    1
    2.2%
    1
    2.3%
    Week 14
    1
    2.3%
    1
    2.2%
    2
    4.7%
    2
    4.4%
    0
    0%
    2
    4.7%
    1
    2.2%
    0
    0%
    Week 15
    0
    0%
    1
    2.2%
    2
    4.7%
    3
    6.7%
    0
    0%
    1
    2.3%
    1
    2.2%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9671
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.06 to 16.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3289
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.16
    Confidence Interval (2-Sided) 95%
    0.31 to 31.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3157
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.26
    Confidence Interval (2-Sided) 95%
    0.32 to 32.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.991
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.06 to 16.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5139
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.20 to 26.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3079
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    0.33 to 33.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0469
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.83
    Confidence Interval (2-Sided) 95%
    1.03 to 75.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0134
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.39
    Confidence Interval (2-Sided) 95%
    1.74 to 119.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1606
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.98
    Confidence Interval (2-Sided) 95%
    0.53 to 46.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0854
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.69
    Confidence Interval (2-Sided) 95%
    0.77 to 58.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1082
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.07
    Confidence Interval (2-Sided) 95%
    0.67 to 54.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0737
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.22
    Confidence Interval (2-Sided) 95%
    0.83 to 63.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0217
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.98
    Confidence Interval (2-Sided) 95%
    1.44 to 99.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 19.24
    Confidence Interval (2-Sided) 95%
    2.36 to 157.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1924
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.44
    Confidence Interval (2-Sided) 95%
    0.47 to 41.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0680
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.54
    Confidence Interval (2-Sided) 95%
    0.86 to 66.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0095
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 15.95
    Confidence Interval (2-Sided) 95%
    1.97 to 129.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2690
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.68
    Confidence Interval (2-Sided) 95%
    0.36 to 37.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0321
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.28
    Confidence Interval (2-Sided) 95%
    1.22 to 86.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0131
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.48
    Confidence Interval (2-Sided) 95%
    1.75 to 119.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 25.22
    Confidence Interval (2-Sided) 95%
    3.11 to 204.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1788
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.65
    Confidence Interval (2-Sided) 95%
    0.49 to 43.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0320
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.33
    Confidence Interval (2-Sided) 95%
    1.22 to 87.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0251
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.24
    Confidence Interval (2-Sided) 95%
    1.35 to 93.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6154
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.43
    Confidence Interval (2-Sided) 95%
    0.35 to 5.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1906
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.65 to 8.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0450
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.67
    Confidence Interval (2-Sided) 95%
    1.03 to 13.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.19
    Confidence Interval (2-Sided) 95%
    2.10 to 24.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3939
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.80
    Confidence Interval (2-Sided) 95%
    0.47 to 6.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2869
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.55 to 7.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1817
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.66 to 8.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0256
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.41
    Confidence Interval (2-Sided) 95%
    1.35 to 96.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0153
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.65
    Confidence Interval (2-Sided) 95%
    1.65 to 112.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 21.76
    Confidence Interval (2-Sided) 95%
    2.64 to 179.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 35.75
    Confidence Interval (2-Sided) 95%
    4.39 to 291.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0967
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.45
    Confidence Interval (2-Sided) 95%
    0.71 to 58.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0564
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.30
    Confidence Interval (2-Sided) 95%
    0.94 to 72.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0030
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 23.63
    Confidence Interval (2-Sided) 95%
    2.93 to 190.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0384
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.72
    Confidence Interval (2-Sided) 95%
    1.13 to 83.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0153
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.65
    Confidence Interval (2-Sided) 95%
    1.65 to 112.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 30.55
    Confidence Interval (2-Sided) 95%
    3.72 to 250.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 35.99
    Confidence Interval (2-Sided) 95%
    4.41 to 293.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0192
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.67
    Confidence Interval (2-Sided) 95%
    1.51 to 106.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0089
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 16.92
    Confidence Interval (2-Sided) 95%
    2.03 to 141.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 24.96
    Confidence Interval (2-Sided) 95%
    3.09 to 201.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0910
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.03
    Confidence Interval (2-Sided) 95%
    0.84 to 10.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0296
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.96
    Confidence Interval (2-Sided) 95%
    1.15 to 13.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.23
    Confidence Interval (2-Sided) 95%
    2.38 to 28.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.54
    Confidence Interval (2-Sided) 95%
    2.46 to 29.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4152
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.76
    Confidence Interval (2-Sided) 95%
    0.45 to 6.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0700
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.29
    Confidence Interval (2-Sided) 95%
    0.91 to 11.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.83
    Confidence Interval (2-Sided) 95%
    1.71 to 19.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1497
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.44
    Confidence Interval (2-Sided) 95%
    0.72 to 8.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0608
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.05
    Confidence Interval (2-Sided) 95%
    0.95 to 9.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.99
    Confidence Interval (2-Sided) 95%
    1.85 to 19.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.84
    Confidence Interval (2-Sided) 95%
    2.45 to 25.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8393
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.30 to 4.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0215
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.01
    Confidence Interval (2-Sided) 95%
    1.23 to 13.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0112
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.42
    Confidence Interval (2-Sided) 95%
    1.40 to 13.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3498
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.55 to 5.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1981
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.05
    Confidence Interval (2-Sided) 95%
    0.69 to 6.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.76 to 15.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.95
    Confidence Interval (2-Sided) 95%
    2.03 to 17.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9511
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.29 to 3.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3241
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.76
    Confidence Interval (2-Sided) 95%
    0.57 to 5.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0111
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.90
    Confidence Interval (2-Sided) 95%
    1.36 to 11.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1375
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.51
    Confidence Interval (2-Sided) 95%
    0.74 to 8.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0670
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.02
    Confidence Interval (2-Sided) 95%
    0.93 to 9.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.57
    Confidence Interval (2-Sided) 95%
    2.29 to 25.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.42
    Confidence Interval (2-Sided) 95%
    2.91 to 30.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0982
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.75
    Confidence Interval (2-Sided) 95%
    0.83 to 9.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1233
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    0.77 to 8.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0091
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.63
    Confidence Interval (2-Sided) 95%
    1.46 to 14.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9620
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.34 to 3.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3527
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.58 to 4.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0394
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.04
    Confidence Interval (2-Sided) 95%
    1.06 to 8.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0224
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.36
    Confidence Interval (2-Sided) 95%
    1.19 to 9.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7891
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.16
    Confidence Interval (2-Sided) 95%
    0.39 to 3.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0851
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.48
    Confidence Interval (2-Sided) 95%
    0.88 to 6.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2885
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.63 to 4.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8611
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.05 to 13.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7549
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.48
    Confidence Interval (2-Sided) 95%
    0.13 to 17.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5658
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.07
    Confidence Interval (2-Sided) 95%
    0.17 to 24.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6319
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.15 to 21.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9526
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.06 to 18.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    20
    46.5%
    27
    60%
    32
    74.4%
    35
    77.8%
    33
    75%
    23
    53.5%
    34
    75.6%
    32
    72.7%
    Week 2
    28
    65.1%
    34
    75.6%
    32
    74.4%
    38
    84.4%
    33
    75%
    32
    74.4%
    36
    80%
    33
    75%
    Week 3
    29
    67.4%
    33
    73.3%
    35
    81.4%
    37
    82.2%
    35
    79.5%
    34
    79.1%
    35
    77.8%
    39
    88.6%
    Week 4
    30
    69.8%
    31
    68.9%
    34
    79.1%
    35
    77.8%
    35
    79.5%
    33
    76.7%
    40
    88.9%
    39
    88.6%
    Week 5
    33
    76.7%
    34
    75.6%
    38
    88.4%
    33
    73.3%
    34
    77.3%
    36
    83.7%
    38
    84.4%
    36
    81.8%
    Week 6
    33
    76.7%
    36
    80%
    37
    86%
    33
    73.3%
    33
    75%
    33
    76.7%
    37
    82.2%
    39
    88.6%
    Week 7
    32
    74.4%
    34
    75.6%
    36
    83.7%
    32
    71.1%
    33
    75%
    32
    74.4%
    37
    82.2%
    38
    86.4%
    Week 8
    34
    79.1%
    35
    77.8%
    36
    83.7%
    34
    75.6%
    32
    72.7%
    33
    76.7%
    37
    82.2%
    37
    84.1%
    Week 9
    33
    76.7%
    34
    75.6%
    37
    86%
    33
    73.3%
    33
    75%
    32
    74.4%
    37
    82.2%
    37
    84.1%
    Week 10
    34
    79.1%
    34
    75.6%
    32
    74.4%
    29
    64.4%
    33
    75%
    33
    76.7%
    36
    80%
    36
    81.8%
    Week 11
    34
    79.1%
    33
    73.3%
    34
    79.1%
    27
    60%
    31
    70.5%
    33
    76.7%
    36
    80%
    36
    81.8%
    Week 12
    31
    72.1%
    34
    75.6%
    31
    72.1%
    28
    62.2%
    31
    70.5%
    31
    72.1%
    35
    77.8%
    35
    79.5%
    Week 13
    17
    39.5%
    30
    66.7%
    26
    60.5%
    22
    48.9%
    22
    50%
    21
    48.8%
    25
    55.6%
    28
    63.6%
    Week 14
    17
    39.5%
    22
    48.9%
    26
    60.5%
    16
    35.6%
    21
    47.7%
    20
    46.5%
    21
    46.7%
    25
    56.8%
    Week 15
    18
    41.9%
    18
    40%
    20
    46.5%
    12
    26.7%
    20
    45.5%
    12
    27.9%
    16
    35.6%
    22
    50%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2251
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.71 to 4.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0084
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.57
    Confidence Interval (2-Sided) 95%
    1.39 to 9.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.71
    Confidence Interval (2-Sided) 95%
    2.09 to 15.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.11
    Confidence Interval (2-Sided) 95%
    1.87 to 14.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6976
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.20
    Confidence Interval (2-Sided) 95%
    0.48 to 2.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.57
    Confidence Interval (2-Sided) 95%
    1.73 to 12.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0171
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.06
    Confidence Interval (2-Sided) 95%
    1.22 to 7.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2224
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.86
    Confidence Interval (2-Sided) 95%
    0.69 to 5.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2716
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.65 to 4.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0112
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.49
    Confidence Interval (2-Sided) 95%
    1.41 to 14.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0461
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.08
    Confidence Interval (2-Sided) 95%
    1.02 to 9.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3463
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.59 to 4.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0419
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.05
    Confidence Interval (2-Sided) 95%
    1.04 to 8.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2977
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.68
    Confidence Interval (2-Sided) 95%
    0.63 to 4.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2300
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.87
    Confidence Interval (2-Sided) 95%
    0.67 to 5.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0655
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.83
    Confidence Interval (2-Sided) 95%
    0.94 to 8.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0245
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.79
    Confidence Interval (2-Sided) 95%
    1.19 to 12.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0129
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.62
    Confidence Interval (2-Sided) 95%
    1.44 to 21.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1259
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.79 to 7.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.40
    Confidence Interval (2-Sided) 95%
    0.84 to 6.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0167
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.48
    Confidence Interval (2-Sided) 95%
    1.31 to 15.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5232
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.40
    Confidence Interval (2-Sided) 95%
    0.50 to 3.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2055
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.00
    Confidence Interval (2-Sided) 95%
    0.68 to 5.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0658
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.00
    Confidence Interval (2-Sided) 95%
    0.93 to 9.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0136
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.34
    Confidence Interval (2-Sided) 95%
    1.51 to 35.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3238
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.59 to 5.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0118
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.86
    Confidence Interval (2-Sided) 95%
    1.48 to 23.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0163
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.29
    Confidence Interval (2-Sided) 95%
    1.36 to 20.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6363
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    0.42 to 4.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0722
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.68
    Confidence Interval (2-Sided) 95%
    0.89 to 15.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.35
    Confidence Interval (2-Sided) 95%
    0.63 to 8.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0337
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.15
    Confidence Interval (2-Sided) 95%
    1.20 to 86.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2207
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.25
    Confidence Interval (2-Sided) 95%
    0.61 to 8.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0849
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.50
    Confidence Interval (2-Sided) 95%
    0.84 to 14.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0844
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.47
    Confidence Interval (2-Sided) 95%
    0.84 to 14.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2383
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.15
    Confidence Interval (2-Sided) 95%
    0.60 to 7.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1653
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.68 to 9.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1836
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.48
    Confidence Interval (2-Sided) 95%
    0.65 to 9.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0529
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.30
    Confidence Interval (2-Sided) 95%
    0.97 to 70.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3197
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.52 to 7.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0376
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.88
    Confidence Interval (2-Sided) 95%
    1.11 to 31.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0343
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.08
    Confidence Interval (2-Sided) 95%
    1.19 to 85.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4435
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.58
    Confidence Interval (2-Sided) 95%
    0.49 to 5.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1805
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.34
    Confidence Interval (2-Sided) 95%
    0.67 to 8.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0857
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.54
    Confidence Interval (2-Sided) 95%
    0.84 to 14.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0316
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.50
    Confidence Interval (2-Sided) 95%
    1.23 to 89.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3471
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.81
    Confidence Interval (2-Sided) 95%
    0.52 to 6.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0313
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.15
    Confidence Interval (2-Sided) 95%
    1.18 to 32.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0208
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.49
    Confidence Interval (2-Sided) 95%
    1.47 to 106.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8669
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.31 to 3.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6592
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.34
    Confidence Interval (2-Sided) 95%
    0.37 to 4.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2923
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.23
    Confidence Interval (2-Sided) 95%
    0.50 to 9.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1145
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.78
    Confidence Interval (2-Sided) 95%
    0.65 to 51.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4470
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.77
    Confidence Interval (2-Sided) 95%
    0.40 to 7.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0753
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.31
    Confidence Interval (2-Sided) 95%
    0.82 to 65.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0829
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.85
    Confidence Interval (2-Sided) 95%
    0.78 to 60.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9978
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.28 to 3.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4571
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.68
    Confidence Interval (2-Sided) 95%
    0.43 to 6.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3681
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.99
    Confidence Interval (2-Sided) 95%
    0.44 to 8.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1038
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.12
    Confidence Interval (2-Sided) 95%
    0.69 to 54.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4639
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.39 to 7.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0770
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.15
    Confidence Interval (2-Sided) 95%
    0.81 to 63.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9838
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.01
    Confidence Interval (2-Sided) 95%
    0.26 to 4.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6995
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.77
    Confidence Interval (2-Sided) 95%
    0.21 to 2.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8808
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.12
    Confidence Interval (2-Sided) 95%
    0.26 to 4.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1570
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.94
    Confidence Interval (2-Sided) 95%
    0.54 to 45.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3742
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.19
    Confidence Interval (2-Sided) 95%
    0.39 to 12.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1436
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.24
    Confidence Interval (2-Sided) 95%
    0.57 to 48.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1277
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.57
    Confidence Interval (2-Sided) 95%
    0.61 to 50.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6689
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.20 to 2.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.20
    Confidence Interval (2-Sided) 95%
    0.29 to 4.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9591
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.23 to 4.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3364
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.33
    Confidence Interval (2-Sided) 95%
    0.42 to 13.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3698
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    0.39 to 12.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1587
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.92
    Confidence Interval (2-Sided) 95%
    0.54 to 45.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1300
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.50
    Confidence Interval (2-Sided) 95%
    0.61 to 50.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4152
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.81
    Confidence Interval (2-Sided) 95%
    0.43 to 7.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9645
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.97
    Confidence Interval (2-Sided) 95%
    0.27 to 3.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3884
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.43 to 8.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2670
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.62
    Confidence Interval (2-Sided) 95%
    0.48 to 14.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0861
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.91
    Confidence Interval (2-Sided) 95%
    0.76 to 62.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0774
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.21
    Confidence Interval (2-Sided) 95%
    0.80 to 64.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0389
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.73
    Confidence Interval (2-Sided) 95%
    1.08 to 20.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3695
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.81
    Confidence Interval (2-Sided) 95%
    0.50 to 6.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3501
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.48 to 7.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2021
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.49
    Confidence Interval (2-Sided) 95%
    0.61 to 10.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6201
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.42
    Confidence Interval (2-Sided) 95%
    0.36 to 5.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0235
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.71
    Confidence Interval (2-Sided) 95%
    1.42 to 132.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0929
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.43
    Confidence Interval (2-Sided) 95%
    0.81 to 14.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9820
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.99
    Confidence Interval (2-Sided) 95%
    0.29 to 3.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4956
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.55
    Confidence Interval (2-Sided) 95%
    0.44 to 5.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5708
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.70
    Confidence Interval (2-Sided) 95%
    0.20 to 2.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1985
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.61 to 10.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8368
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.31 to 4.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1397
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.18
    Confidence Interval (2-Sided) 95%
    0.68 to 14.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0366
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.88
    Confidence Interval (2-Sided) 95%
    0.52 to 6.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7968
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.84
    Confidence Interval (2-Sided) 95%
    0.23 to 3.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9074
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.30 to 3.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1987
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.41
    Confidence Interval (2-Sided) 95%
    0.10 to 1.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2040
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.58
    Confidence Interval (2-Sided) 95%
    0.60 to 11.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3318
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.51
    Confidence Interval (2-Sided) 95%
    0.13 to 1.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7437
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.26
    Confidence Interval (2-Sided) 95%
    0.31 to 5.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6848
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.30
    Confidence Interval (2-Sided) 95%
    0.36 to 4.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    14
    32.6%
    23
    51.1%
    29
    67.4%
    32
    71.1%
    28
    63.6%
    18
    41.9%
    31
    68.9%
    29
    65.9%
    Week 2
    19
    44.2%
    30
    66.7%
    30
    69.8%
    36
    80%
    32
    72.7%
    28
    65.1%
    33
    73.3%
    31
    70.5%
    Week 3
    24
    55.8%
    31
    68.9%
    30
    69.8%
    36
    80%
    34
    77.3%
    29
    67.4%
    34
    75.6%
    32
    72.7%
    Week 4
    26
    60.5%
    30
    66.7%
    32
    74.4%
    34
    75.6%
    34
    77.3%
    29
    67.4%
    35
    77.8%
    34
    77.3%
    Week 5
    29
    67.4%
    31
    68.9%
    36
    83.7%
    33
    73.3%
    33
    75%
    34
    79.1%
    35
    77.8%
    33
    75%
    Week 6
    28
    65.1%
    29
    64.4%
    33
    76.7%
    31
    68.9%
    32
    72.7%
    30
    69.8%
    36
    80%
    38
    86.4%
    Week 7
    30
    69.8%
    31
    68.9%
    34
    79.1%
    30
    66.7%
    32
    72.7%
    31
    72.1%
    37
    82.2%
    38
    86.4%
    Week 8
    31
    72.1%
    32
    71.1%
    34
    79.1%
    32
    71.1%
    29
    65.9%
    31
    72.1%
    37
    82.2%
    34
    77.3%
    Week 9
    30
    69.8%
    32
    71.1%
    33
    76.7%
    32
    71.1%
    32
    72.7%
    31
    72.1%
    36
    80%
    34
    77.3%
    Week 10
    29
    67.4%
    32
    71.1%
    29
    67.4%
    29
    64.4%
    31
    70.5%
    31
    72.1%
    36
    80%
    34
    77.3%
    Week 11
    30
    69.8%
    31
    68.9%
    30
    69.8%
    27
    60%
    30
    68.2%
    32
    74.4%
    36
    80%
    34
    77.3%
    Week 12
    28
    65.1%
    31
    68.9%
    31
    72.1%
    27
    60%
    28
    63.6%
    30
    69.8%
    34
    75.6%
    33
    75%
    Week 13
    16
    37.2%
    24
    53.3%
    20
    46.5%
    21
    46.7%
    18
    40.9%
    20
    46.5%
    19
    42.2%
    26
    59.1%
    Week 14
    15
    34.9%
    18
    40%
    21
    48.8%
    15
    33.3%
    17
    38.6%
    17
    39.5%
    18
    40%
    23
    52.3%
    Week 15
    17
    39.5%
    15
    33.3%
    18
    41.9%
    12
    26.7%
    13
    29.5%
    11
    25.6%
    14
    31.1%
    17
    38.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1114
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.12
    Confidence Interval (2-Sided) 95%
    0.84 to 5.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.69
    Confidence Interval (2-Sided) 95%
    1.83 to 12.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.01
    Confidence Interval (2-Sided) 95%
    2.65 to 18.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.96
    Confidence Interval (2-Sided) 95%
    1.91 to 12.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6384
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    0.49 to 3.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.77
    Confidence Interval (2-Sided) 95%
    2.23 to 14.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.15
    Confidence Interval (2-Sided) 95%
    1.65 to 10.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0279
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    1.12 to 7.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0114
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.36
    Confidence Interval (2-Sided) 95%
    1.31 to 8.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.55
    Confidence Interval (2-Sided) 95%
    2.66 to 21.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.41
    Confidence Interval (2-Sided) 95%
    2.25 to 18.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0695
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.93 to 6.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.83
    Confidence Interval (2-Sided) 95%
    1.83 to 12.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0120
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.28
    Confidence Interval (2-Sided) 95%
    1.30 to 8.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.662
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.49
    Confidence Interval (2-Sided) 95%
    0.94 to 6.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.85 to 5.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.44
    Confidence Interval (2-Sided) 95%
    1.83 to 16.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.33
    Confidence Interval (2-Sided) 95%
    2.15 to 25.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2380
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.78
    Confidence Interval (2-Sided) 95%
    0.68 to 4.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0120
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.61
    Confidence Interval (2-Sided) 95%
    1.33 to 9.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0910
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.25
    Confidence Interval (2-Sided) 95%
    0.88 to 5.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1926
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.93
    Confidence Interval (2-Sided) 95%
    0.72 to 5.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1017
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.85 to 6.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0153
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.85
    Confidence Interval (2-Sided) 95%
    1.29 to 11.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.52
    Confidence Interval (2-Sided) 95%
    1.95 to 28.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4539
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.44
    Confidence Interval (2-Sided) 95%
    0.55 to 3.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0327
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.03
    Confidence Interval (2-Sided) 95%
    1.10 to 8.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0555
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.67
    Confidence Interval (2-Sided) 95%
    0.98 to 7.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3505
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.64
    Confidence Interval (2-Sided) 95%
    0.58 to 4.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0265
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    1.17 to 13.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0174
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.77
    Confidence Interval (2-Sided) 95%
    1.32 to 17.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.95
    Confidence Interval (2-Sided) 95%
    1.80 to 44.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1228
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.46
    Confidence Interval (2-Sided) 95%
    0.78 to 7.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0431
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.28
    Confidence Interval (2-Sided) 95%
    1.04 to 10.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0851
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    0.87 to 8.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4726
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.45
    Confidence Interval (2-Sided) 95%
    0.53 to 3.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1289
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.79 to 6.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0400
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.39
    Confidence Interval (2-Sided) 95%
    1.06 to 10.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0097
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.22
    Confidence Interval (2-Sided) 95%
    1.67 to 40.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2260
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.97
    Confidence Interval (2-Sided) 95%
    0.66 to 5.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.63
    Confidence Interval (2-Sided) 95%
    2.07 to 35.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.16
    Confidence Interval (2-Sided) 95%
    2.07 to 49.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5571
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.38
    Confidence Interval (2-Sided) 95%
    0.47 to 4.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1911
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.13
    Confidence Interval (2-Sided) 95%
    0.69 to 6.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1101
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.74
    Confidence Interval (2-Sided) 95%
    0.80 to 9.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.86
    Confidence Interval (2-Sided) 95%
    1.36 to 34.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2600
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.96
    Confidence Interval (2-Sided) 95%
    0.61 to 6.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0090
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.93
    Confidence Interval (2-Sided) 95%
    1.73 to 46.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0089
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 17.22
    Confidence Interval (2-Sided) 95%
    2.04 to 145.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8966
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    0.36 to 3.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.48 to 4.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2603
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.59 to 6.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2447
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.16
    Confidence Interval (2-Sided) 95%
    0.59 to 7.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4239
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.64
    Confidence Interval (2-Sided) 95%
    0.49 to 5.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0240
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.72
    Confidence Interval (2-Sided) 95%
    1.38 to 99.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1457
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    0.72 to 9.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9000
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.34 to 3.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7644
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    0.39 to 3.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2245
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.60 to 8.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0475
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.02 to 27.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2569
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.15
    Confidence Interval (2-Sided) 95%
    0.57 to 8.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0412
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.32
    Confidence Interval (2-Sided) 95%
    1.09 to 79.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1201
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.84
    Confidence Interval (2-Sided) 95%
    0.76 to 10.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3814
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.67
    Confidence Interval (2-Sided) 95%
    0.53 to 5.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8549
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.38 to 3.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1274
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.77
    Confidence Interval (2-Sided) 95%
    0.75 to 10.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0703
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.67
    Confidence Interval (2-Sided) 95%
    0.90 to 15.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1821
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.66 to 8.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0187
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.96
    Confidence Interval (2-Sided) 95%
    1.53 to 109.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0458
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.18
    Confidence Interval (2-Sided) 95%
    1.03 to 17.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6806
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.27
    Confidence Interval (2-Sided) 95%
    0.41 to 3.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8090
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.38 to 3.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2352
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.60 to 8.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1231
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.04
    Confidence Interval (2-Sided) 95%
    0.74 to 12.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1445
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.86
    Confidence Interval (2-Sided) 95%
    0.70 to 11.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0230
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.03
    Confidence Interval (2-Sided) 95%
    1.41 to 102.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0801
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.51
    Confidence Interval (2-Sided) 95%
    0.86 to 14.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4152
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.50 to 5.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3845
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.70
    Confidence Interval (2-Sided) 95%
    0.51 to 5.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1864
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.46
    Confidence Interval (2-Sided) 95%
    0.65 to 9.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.01268
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.06
    Confidence Interval (2-Sided) 95%
    0.73 to 12.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1600
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.80
    Confidence Interval (2-Sided) 95%
    0.67 to 11.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0317
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.13
    Confidence Interval (2-Sided) 95%
    1.17 to 32.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0709
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.73
    Confidence Interval (2-Sided) 95%
    0.89 to 15.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4533
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.60
    Confidence Interval (2-Sided) 95%
    0.47 to 5.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7053
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.80
    Confidence Interval (2-Sided) 95%
    0.24 to 2.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3677
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.84
    Confidence Interval (2-Sided) 95%
    0.49 to 6.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7350
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.24
    Confidence Interval (2-Sided) 95%
    0.35 to 4.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6443
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.37
    Confidence Interval (2-Sided) 95%
    0.36 to 5.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4865
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.58
    Confidence Interval (2-Sided) 95%
    0.43 to 5.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1628
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.52
    Confidence Interval (2-Sided) 95%
    0.69 to 9.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6935
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    0.24 to 2.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9753
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.32 to 3.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7407
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.81
    Confidence Interval (2-Sided) 95%
    0.23 to 2.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4929
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.55
    Confidence Interval (2-Sided) 95%
    0.44 to 5.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8496
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95%
    0.25 to 3.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3248
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.92
    Confidence Interval (2-Sided) 95%
    0.52 to 7.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2589
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.59 to 6.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3318
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.54
    Confidence Interval (2-Sided) 95%
    0.16 to 1.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8536
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.89
    Confidence Interval (2-Sided) 95%
    0.26 to 3.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2817
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.48
    Confidence Interval (2-Sided) 95%
    0.12 to 1.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4091
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.59
    Confidence Interval (2-Sided) 95%
    0.17 to 2.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3147
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.50
    Confidence Interval (2-Sided) 95%
    0.13 to 1.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8547
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.89
    Confidence Interval (2-Sided) 95%
    0.24 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5023
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.66
    Confidence Interval (2-Sided) 95%
    0.20 to 2.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    8
    18.6%
    21
    46.7%
    21
    48.8%
    26
    57.8%
    24
    54.5%
    16
    37.2%
    22
    48.9%
    29
    65.9%
    Week 2
    16
    37.2%
    27
    60%
    29
    67.4%
    33
    73.3%
    28
    63.6%
    25
    58.1%
    27
    60%
    26
    59.1%
    Week 3
    18
    41.9%
    28
    62.2%
    27
    62.8%
    33
    73.3%
    31
    70.5%
    26
    60.5%
    33
    73.3%
    31
    70.5%
    Week 4
    22
    51.2%
    27
    60%
    28
    65.1%
    31
    68.9%
    30
    68.2%
    26
    60.5%
    32
    71.1%
    31
    70.5%
    Week 5
    24
    55.8%
    28
    62.2%
    31
    72.1%
    30
    66.7%
    33
    75%
    28
    65.1%
    34
    75.6%
    31
    70.5%
    Week 6
    27
    62.8%
    28
    62.2%
    27
    62.8%
    31
    68.9%
    30
    68.2%
    26
    60.5%
    34
    75.6%
    33
    75%
    Week 7
    27
    62.8%
    27
    60%
    32
    74.4%
    30
    66.7%
    30
    68.2%
    26
    60.5%
    33
    73.3%
    32
    72.7%
    Week 8
    28
    65.1%
    29
    64.4%
    32
    74.4%
    31
    68.9%
    29
    65.9%
    28
    65.1%
    34
    75.6%
    30
    68.2%
    Week 9
    28
    65.1%
    30
    66.7%
    31
    72.1%
    32
    71.1%
    31
    70.5%
    28
    65.1%
    35
    77.8%
    32
    72.7%
    Week 10
    27
    62.8%
    29
    64.4%
    27
    62.8%
    28
    62.2%
    30
    68.2%
    30
    69.8%
    34
    75.6%
    31
    70.5%
    Week 11
    27
    62.8%
    28
    62.2%
    28
    65.1%
    26
    57.8%
    30
    68.2%
    30
    69.8%
    35
    77.8%
    31
    70.5%
    Week 12
    25
    58.1%
    26
    57.8%
    28
    65.1%
    27
    60%
    27
    61.4%
    27
    62.8%
    33
    73.3%
    32
    72.7%
    Week 13
    12
    27.9%
    20
    44.4%
    16
    37.2%
    18
    40%
    17
    38.6%
    18
    41.9%
    17
    37.8%
    23
    52.3%
    Week 14
    14
    32.6%
    16
    35.6%
    17
    39.5%
    12
    26.7%
    13
    29.5%
    16
    37.2%
    15
    33.3%
    18
    40.9%
    Week 15
    15
    34.9%
    14
    31.1%
    13
    30.2%
    9
    20%
    12
    27.3%
    10
    23.3%
    12
    26.7%
    13
    29.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0093
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.99
    Confidence Interval (2-Sided) 95%
    1.41 to 11.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.66
    Confidence Interval (2-Sided) 95%
    1.66 to 13.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.48
    Confidence Interval (2-Sided) 95%
    3.01 to 23.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.57
    Confidence Interval (2-Sided) 95%
    2.65 to 21.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1664
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.13
    Confidence Interval (2-Sided) 95%
    0.73 to 6.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.39
    Confidence Interval (2-Sided) 95%
    1.94 to 14.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.85
    Confidence Interval (2-Sided) 95%
    3.49 to 27.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0334
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.73
    Confidence Interval (2-Sided) 95%
    1.08 to 6.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.12
    Confidence Interval (2-Sided) 95%
    1.60 to 10.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.55
    Confidence Interval (2-Sided) 95%
    2.45 to 17.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.90
    Confidence Interval (2-Sided) 95%
    1.85 to 12.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0872
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.89 to 5.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0131
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.19
    Confidence Interval (2-Sided) 95%
    1.28 to 7.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0386
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    1.05 to 6.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0191
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.11
    Confidence Interval (2-Sided) 95%
    1.20 to 8.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0291
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.84
    Confidence Interval (2-Sided) 95%
    1.11 to 7.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.09
    Confidence Interval (2-Sided) 95%
    2.23 to 16.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.24
    Confidence Interval (2-Sided) 95%
    2.49 to 21.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0992
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.86 to 5.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.66
    Confidence Interval (2-Sided) 95%
    2.11 to 15.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.74
    Confidence Interval (2-Sided) 95%
    1.46 to 9.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1472
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.01
    Confidence Interval (2-Sided) 95%
    0.78 to 5.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1284
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.05
    Confidence Interval (2-Sided) 95%
    0.81 to 5.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0117
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.55
    Confidence Interval (2-Sided) 95%
    1.32 to 9.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0067
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.24
    Confidence Interval (2-Sided) 95%
    1.49 to 12.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4088
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.59 to 3.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0194
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.09
    Confidence Interval (2-Sided) 95%
    1.20 to 7.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0423
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    1.03 to 6.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2151
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.86
    Confidence Interval (2-Sided) 95%
    0.70 to 4.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0531
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.71
    Confidence Interval (2-Sided) 95%
    0.99 to 7.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0118
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.11
    Confidence Interval (2-Sided) 95%
    1.37 to 12.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 16.28
    Confidence Interval (2-Sided) 95%
    3.29 to 80.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3698
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.57
    Confidence Interval (2-Sided) 95%
    0.59 to 4.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.58
    Confidence Interval (2-Sided) 95%
    1.55 to 13.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0241
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    1.17 to 9.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5308
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.38
    Confidence Interval (2-Sided) 95%
    0.50 to 3.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8603
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.41 to 2.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0264
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.73
    Confidence Interval (2-Sided) 95%
    1.17 to 11.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0188
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.60
    Confidence Interval (2-Sided) 95%
    1.29 to 16.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7642
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.17
    Confidence Interval (2-Sided) 95%
    0.42 to 3.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0101
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.91
    Confidence Interval (2-Sided) 95%
    1.46 to 16.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0572
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.88
    Confidence Interval (2-Sided) 95%
    0.97 to 8.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7348
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    0.44 to 3.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1397
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    0.77 to 6.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0231
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.07
    Confidence Interval (2-Sided) 95%
    1.21 to 13.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0196
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.54
    Confidence Interval (2-Sided) 95%
    1.27 to 16.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7703
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.16
    Confidence Interval (2-Sided) 95%
    0.42 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0222
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.83
    Confidence Interval (2-Sided) 95%
    1.21 to 12.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0668
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.77
    Confidence Interval (2-Sided) 95%
    0.93 to 8.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7533
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    0.43 to 3.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3325
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.67
    Confidence Interval (2-Sided) 95%
    0.59 to 4.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0899
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.71
    Confidence Interval (2-Sided) 95%
    0.86 to 8.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0642
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.31
    Confidence Interval (2-Sided) 95%
    0.93 to 11.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5964
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.34
    Confidence Interval (2-Sided) 95%
    0.46 to 3.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0224
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.43
    Confidence Interval (2-Sided) 95%
    1.23 to 15.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3139
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.72
    Confidence Interval (2-Sided) 95%
    0.60 to 4.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6343
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.30
    Confidence Interval (2-Sided) 95%
    0.45 to 3.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6557
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.27
    Confidence Interval (2-Sided) 95%
    0.45 to 3.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0516
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.66
    Confidence Interval (2-Sided) 95%
    0.99 to 13.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0400
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.38
    Confidence Interval (2-Sided) 95%
    1.07 to 17.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5825
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.37
    Confidence Interval (2-Sided) 95%
    0.44 to 4.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0152
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.46
    Confidence Interval (2-Sided) 95%
    1.47 to 37.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1565
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.30
    Confidence Interval (2-Sided) 95%
    0.73 to 7.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4932
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.45
    Confidence Interval (2-Sided) 95%
    0.50 to 4.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8504
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.39 to 3.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0759
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.07
    Confidence Interval (2-Sided) 95%
    0.89 to 10.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0477
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.69
    Confidence Interval (2-Sided) 95%
    1.01 to 13.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1448
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.47
    Confidence Interval (2-Sided) 95%
    0.73 to 8.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0173
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.54
    Confidence Interval (2-Sided) 95%
    1.35 to 22.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1101
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.57
    Confidence Interval (2-Sided) 95%
    0.81 to 8.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6022
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    0.46 to 3.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6128
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.46 to 3.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    0.82 to 9.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0255
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.95
    Confidence Interval (2-Sided) 95%
    1.22 to 20.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1521
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.42
    Confidence Interval (2-Sided) 95%
    0.72 to 8.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0071
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.37
    Confidence Interval (2-Sided) 95%
    1.84 to 47.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1150
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.52
    Confidence Interval (2-Sided) 95%
    0.80 to 7.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8101
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.14
    Confidence Interval (2-Sided) 95%
    0.40 to 3.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4663
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.49
    Confidence Interval (2-Sided) 95%
    0.51 to 4.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0453
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.80
    Confidence Interval (2-Sided) 95%
    1.03 to 14.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0659
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.36
    Confidence Interval (2-Sided) 95%
    0.92 to 12.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3117
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.57 to 5.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0129
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.02
    Confidence Interval (2-Sided) 95%
    1.46 to 24.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0303
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.12
    Confidence Interval (2-Sided) 95%
    1.14 to 14.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2772
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.94
    Confidence Interval (2-Sided) 95%
    0.59 to 6.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9432
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.29 to 3.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2577
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.59 to 7.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1496
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.71 to 9.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2874
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.05
    Confidence Interval (2-Sided) 95%
    0.55 to 7.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1981
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.65 to 7.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0531
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.35
    Confidence Interval (2-Sided) 95%
    0.98 to 11.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5858
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.72
    Confidence Interval (2-Sided) 95%
    0.22 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5122
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.68
    Confidence Interval (2-Sided) 95%
    0.21 to 2.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3415
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.55
    Confidence Interval (2-Sided) 95%
    0.16 to 1.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8263
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.87
    Confidence Interval (2-Sided) 95%
    0.25 to 2.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8085
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.86
    Confidence Interval (2-Sided) 95%
    0.24 to 3.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6745
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.30
    Confidence Interval (2-Sided) 95%
    0.38 to 4.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.34 to 3.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4425
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.18 to 2.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3106
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.54
    Confidence Interval (2-Sided) 95%
    0.17 to 1.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0912
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.32
    Confidence Interval (2-Sided) 95%
    0.08 to 1.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5681
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.70
    Confidence Interval (2-Sided) 95%
    0.20 to 2.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4261
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.58
    Confidence Interval (2-Sided) 95%
    0.15 to 2.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7514
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    0.24 to 2.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2712
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.52
    Confidence Interval (2-Sided) 95%
    0.16 to 1.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    24. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    5
    11.6%
    17
    37.8%
    19
    44.2%
    22
    48.9%
    21
    47.7%
    13
    30.2%
    18
    40%
    20
    45.5%
    Week 2
    14
    32.6%
    25
    55.6%
    24
    55.8%
    27
    60%
    24
    54.5%
    21
    48.8%
    23
    51.1%
    26
    59.1%
    Week 3
    16
    37.2%
    25
    55.6%
    25
    58.1%
    29
    64.4%
    27
    61.4%
    25
    58.1%
    29
    64.4%
    27
    61.4%
    Week 4
    17
    39.5%
    24
    53.3%
    26
    60.5%
    25
    55.6%
    28
    63.6%
    24
    55.8%
    31
    68.9%
    27
    61.4%
    Week 5
    20
    46.5%
    24
    53.3%
    26
    60.5%
    26
    57.8%
    28
    63.6%
    26
    60.5%
    32
    71.1%
    28
    63.6%
    Week 6
    22
    51.2%
    24
    53.3%
    25
    58.1%
    30
    66.7%
    27
    61.4%
    25
    58.1%
    30
    66.7%
    30
    68.2%
    Week 7
    22
    51.2%
    27
    60%
    27
    62.8%
    27
    60%
    28
    63.6%
    24
    55.8%
    28
    62.2%
    30
    68.2%
    Week 8
    22
    51.2%
    26
    57.8%
    26
    60.5%
    28
    62.2%
    26
    59.1%
    23
    53.5%
    31
    68.9%
    30
    68.2%
    Week 9
    26
    60.5%
    25
    55.6%
    26
    60.5%
    28
    62.2%
    28
    63.6%
    23
    53.5%
    32
    71.1%
    30
    68.2%
    Week 10
    22
    51.2%
    26
    57.8%
    23
    53.5%
    25
    55.6%
    29
    65.9%
    25
    58.1%
    32
    71.1%
    30
    68.2%
    Week 11
    24
    55.8%
    27
    60%
    25
    58.1%
    24
    53.3%
    27
    61.4%
    27
    62.8%
    33
    73.3%
    30
    68.2%
    Week 12
    23
    53.5%
    23
    51.1%
    26
    60.5%
    22
    48.9%
    26
    59.1%
    24
    55.8%
    31
    68.9%
    29
    65.9%
    Week 13
    9
    20.9%
    18
    40%
    13
    30.2%
    14
    31.1%
    14
    31.8%
    17
    39.5%
    13
    28.9%
    17
    38.6%
    Week 14
    10
    23.3%
    15
    33.3%
    12
    27.9%
    10
    22.2%
    9
    20.5%
    16
    37.2%
    13
    28.9%
    14
    31.8%
    Week 15
    11
    25.6%
    11
    24.4%
    9
    20.9%
    8
    17.8%
    7
    15.9%
    9
    20.9%
    11
    24.4%
    12
    27.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0103
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.89
    Confidence Interval (2-Sided) 95%
    1.46 to 16.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.19
    Confidence Interval (2-Sided) 95%
    2.20 to 23.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.06
    Confidence Interval (2-Sided) 95%
    3.41 to 35.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.48
    Confidence Interval (2-Sided) 95%
    3.18 to 34.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1571
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.46
    Confidence Interval (2-Sided) 95%
    0.71 to 8.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.14
    Confidence Interval (2-Sided) 95%
    2.21 to 23.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.35
    Confidence Interval (2-Sided) 95%
    2.29 to 23.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0342
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.78
    Confidence Interval (2-Sided) 95%
    1.08 to 7.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0231
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.98
    Confidence Interval (2-Sided) 95%
    1.16 to 7.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.12
    Confidence Interval (2-Sided) 95%
    1.60 to 10.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.89
    Confidence Interval (2-Sided) 95%
    1.48 to 10.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2471
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.76
    Confidence Interval (2-Sided) 95%
    0.68 to 4.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0381
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.66
    Confidence Interval (2-Sided) 95%
    1.05 to 6.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0113
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.34
    Confidence Interval (2-Sided) 95%
    1.31 to 8.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0486
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.56
    Confidence Interval (2-Sided) 95%
    1.01 to 6.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0350
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.71
    Confidence Interval (2-Sided) 95%
    1.07 to 6.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.24
    Confidence Interval (2-Sided) 95%
    1.65 to 10.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.68
    Confidence Interval (2-Sided) 95%
    1.76 to 12.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0686
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.94 to 6.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.02
    Confidence Interval (2-Sided) 95%
    1.58 to 10.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0222
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.90
    Confidence Interval (2-Sided) 95%
    1.16 to 7.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0876
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.28
    Confidence Interval (2-Sided) 95%
    0.89 to 5.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0345
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.72
    Confidence Interval (2-Sided) 95%
    1.08 to 6.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0319
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.76
    Confidence Interval (2-Sided) 95%
    1.09 to 6.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.27
    Confidence Interval (2-Sided) 95%
    1.92 to 14.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1751
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.91
    Confidence Interval (2-Sided) 95%
    0.75 to 4.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.46
    Confidence Interval (2-Sided) 95%
    1.73 to 11.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0284
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.79
    Confidence Interval (2-Sided) 95%
    1.11 to 6.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2650
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.72
    Confidence Interval (2-Sided) 95%
    0.66 to 4.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1238
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.10
    Confidence Interval (2-Sided) 95%
    0.82 to 5.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0219
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.22
    Confidence Interval (2-Sided) 95%
    1.18 to 8.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.46
    Confidence Interval (2-Sided) 95%
    1.84 to 16.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2230
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.82
    Confidence Interval (2-Sided) 95%
    0.69 to 4.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.05
    Confidence Interval (2-Sided) 95%
    1.83 to 13.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0205
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.17
    Confidence Interval (2-Sided) 95%
    1.19 to 8.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4628
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.44
    Confidence Interval (2-Sided) 95%
    0.54 to 3.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.51
    Confidence Interval (2-Sided) 95%
    0.58 to 3.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.39
    Confidence Interval (2-Sided) 95%
    1.76 to 16.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0115
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.15
    Confidence Interval (2-Sided) 95%
    1.38 to 12.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2513
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.81
    Confidence Interval (2-Sided) 95%
    0.66 to 4.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0099
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.94
    Confidence Interval (2-Sided) 95%
    1.39 to 11.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0242
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.19
    Confidence Interval (2-Sided) 95%
    1.16 to 8.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1518
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.07
    Confidence Interval (2-Sided) 95%
    0.77 to 5.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1811
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.73 to 5.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0150
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.88
    Confidence Interval (2-Sided) 95%
    1.30 to 11.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.67 to 16.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3788
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.58
    Confidence Interval (2-Sided) 95%
    0.57 to 4.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0424
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    1.04 to 7.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0139
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.69
    Confidence Interval (2-Sided) 95%
    1.30 to 10.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3057
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.67
    Confidence Interval (2-Sided) 95%
    0.63 to 4.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3717
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.55
    Confidence Interval (2-Sided) 95%
    0.59 to 4.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0252
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    1.16 to 9.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0235
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.56
    Confidence Interval (2-Sided) 95%
    1.19 to 10.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6580
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    0.46 to 3.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.58
    Confidence Interval (2-Sided) 95%
    1.54 to 13.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0149
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.70
    Confidence Interval (2-Sided) 95%
    1.29 to 10.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9282
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.95
    Confidence Interval (2-Sided) 95%
    0.35 to 2.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7902
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.87
    Confidence Interval (2-Sided) 95%
    0.33 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1603
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.73 to 6.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1144
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.80 to 8.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5903
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.26 to 2.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0290
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.89
    Confidence Interval (2-Sided) 95%
    1.15 to 13.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1721
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.12
    Confidence Interval (2-Sided) 95%
    0.72 to 6.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2439
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.66 to 5.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7402
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    0.44 to 3.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0422
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.17
    Confidence Interval (2-Sided) 95%
    1.04 to 9.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.44
    Confidence Interval (2-Sided) 95%
    1.62 to 18.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3191
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.59 to 4.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.91
    Confidence Interval (2-Sided) 95%
    1.78 to 19.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0139
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.02
    Confidence Interval (2-Sided) 95%
    1.33 to 12.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3757
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.59
    Confidence Interval (2-Sided) 95%
    0.57 to 4.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7087
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.45 to 3.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1083
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    0.81 to 7.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0473
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.21
    Confidence Interval (2-Sided) 95%
    1.01 to 10.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2481
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.89
    Confidence Interval (2-Sided) 95%
    0.64 to 5.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0066
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.84
    Confidence Interval (2-Sided) 95%
    1.64 to 20.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0466
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.06
    Confidence Interval (2-Sided) 95%
    1.02 to 9.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8769
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) 95%
    0.34 to 2.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5448
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.37
    Confidence Interval (2-Sided) 95%
    0.49 to 3.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4125
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.57
    Confidence Interval (2-Sided) 95%
    0.53 to 4.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0500
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.36
    Confidence Interval (2-Sided) 95%
    1.00 to 11.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6167
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    0.45 to 3.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0233
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.00
    Confidence Interval (2-Sided) 95%
    1.21 to 13.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0803
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.68
    Confidence Interval (2-Sided) 95%
    0.89 to 8.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1274
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    0.76 to 9.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9445
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.05
    Confidence Interval (2-Sided) 95%
    0.29 to 3.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4204
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.69
    Confidence Interval (2-Sided) 95%
    0.47 to 6.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1315
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.78
    Confidence Interval (2-Sided) 95%
    0.74 to 10.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0944
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.24
    Confidence Interval (2-Sided) 95%
    0.82 to 12.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2801
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.99
    Confidence Interval (2-Sided) 95%
    0.57 to 6.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1524
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.44
    Confidence Interval (2-Sided) 95%
    0.72 to 8.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6129
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.38
    Confidence Interval (2-Sided) 95%
    0.40 to 4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4617
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.63
    Confidence Interval (2-Sided) 95%
    0.18 to 2.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6519
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.20 to 2.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8011
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.84
    Confidence Interval (2-Sided) 95%
    0.22 to 3.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3254
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.51 to 7.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2730
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.00
    Confidence Interval (2-Sided) 95%
    0.58 to 6.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6601
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.39 to 4.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6588
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.20 to 2.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3257
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.52
    Confidence Interval (2-Sided) 95%
    0.14 to 1.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2229
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.42
    Confidence Interval (2-Sided) 95%
    0.10 to 1.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2425
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.43
    Confidence Interval (2-Sided) 95%
    0.10 to 1.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9672
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.97
    Confidence Interval (2-Sided) 95%
    0.23 to 4.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5838
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.43
    Confidence Interval (2-Sided) 95%
    0.40 to 5.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9361
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.95
    Confidence Interval (2-Sided) 95%
    0.28 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    25. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    22
    51.2%
    33
    73.3%
    32
    74.4%
    35
    77.8%
    36
    81.8%
    28
    65.1%
    34
    75.6%
    32
    72.7%
    Week 2
    30
    69.8%
    36
    80%
    33
    76.7%
    37
    82.2%
    36
    81.8%
    36
    83.7%
    38
    84.4%
    33
    75%
    Week 3
    31
    72.1%
    33
    73.3%
    36
    83.7%
    36
    80%
    36
    81.8%
    37
    86%
    37
    82.2%
    39
    88.6%
    Week 4
    31
    72.1%
    34
    75.6%
    34
    79.1%
    34
    75.6%
    36
    81.8%
    36
    83.7%
    40
    88.9%
    39
    88.6%
    Week 5
    32
    74.4%
    34
    75.6%
    39
    90.7%
    32
    71.1%
    35
    79.5%
    37
    86%
    39
    86.7%
    35
    79.5%
    Week 6
    33
    76.7%
    36
    80%
    37
    86%
    32
    71.1%
    33
    75%
    34
    79.1%
    37
    82.2%
    38
    86.4%
    Week 7
    33
    76.7%
    35
    77.8%
    36
    83.7%
    31
    68.9%
    34
    77.3%
    34
    79.1%
    37
    82.2%
    38
    86.4%
    Week 8
    35
    81.4%
    36
    80%
    36
    83.7%
    32
    71.1%
    33
    75%
    35
    81.4%
    37
    82.2%
    37
    84.1%
    Week 9
    33
    76.7%
    35
    77.8%
    37
    86%
    31
    68.9%
    33
    75%
    34
    79.1%
    37
    82.2%
    37
    84.1%
    Week 10
    34
    79.1%
    35
    77.8%
    32
    74.4%
    28
    62.2%
    33
    75%
    34
    79.1%
    36
    80%
    35
    79.5%
    Week 11
    34
    79.1%
    35
    77.8%
    34
    79.1%
    26
    57.8%
    32
    72.7%
    34
    79.1%
    36
    80%
    36
    81.8%
    Week 12
    31
    72.1%
    35
    77.8%
    31
    72.1%
    27
    60%
    31
    70.5%
    32
    74.4%
    35
    77.8%
    35
    79.5%
    Week 13
    17
    39.5%
    29
    64.4%
    27
    62.8%
    21
    46.7%
    24
    54.5%
    24
    55.8%
    22
    48.9%
    27
    61.4%
    Week 14
    17
    39.5%
    23
    51.1%
    26
    60.5%
    17
    37.8%
    20
    45.5%
    23
    53.5%
    22
    48.9%
    25
    56.8%
    Week 15
    18
    41.9%
    19
    42.2%
    22
    51.2%
    14
    31.1%
    19
    43.2%
    14
    32.6%
    17
    37.8%
    21
    47.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0429
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    1.03 to 6.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0296
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.81
    Confidence Interval (2-Sided) 95%
    1.11 to 7.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.48
    Confidence Interval (2-Sided) 95%
    1.65 to 12.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.11
    Confidence Interval (2-Sided) 95%
    2.31 to 21.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2073
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.80
    Confidence Interval (2-Sided) 95%
    0.72 to 4.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0096
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.54
    Confidence Interval (2-Sided) 95%
    1.36 to 9.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0462
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.52
    Confidence Interval (2-Sided) 95%
    1.02 to 6.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1387
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.77 to 6.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3130
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.60 to 4.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0392
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    1.06 to 10.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0135
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.70
    Confidence Interval (2-Sided) 95%
    1.43 to 22.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0840
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.85
    Confidence Interval (2-Sided) 95%
    0.87 to 9.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0163
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.47
    Confidence Interval (2-Sided) 95%
    1.32 to 15.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5056
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.41
    Confidence Interval (2-Sided) 95%
    0.52 to 3.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3358
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.69
    Confidence Interval (2-Sided) 95%
    0.58 to 4.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0696
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.05
    Confidence Interval (2-Sided) 95%
    0.91 to 10.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0794
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.80
    Confidence Interval (2-Sided) 95%
    0.89 to 8.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0149
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.32
    Confidence Interval (2-Sided) 95%
    1.48 to 36.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0377
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.37
    Confidence Interval (2-Sided) 95%
    1.09 to 17.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0454
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.32
    Confidence Interval (2-Sided) 95%
    1.03 to 10.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0390
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.77
    Confidence Interval (2-Sided) 95%
    1.07 to 13.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1947
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.12
    Confidence Interval (2-Sided) 95%
    0.68 to 6.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2913
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.79
    Confidence Interval (2-Sided) 95%
    0.61 to 5.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1665
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.21
    Confidence Interval (2-Sided) 95%
    0.72 to 6.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0157
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.41
    Confidence Interval (2-Sided) 95%
    1.63 to 110.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0846
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.01
    Confidence Interval (2-Sided) 95%
    0.86 to 10.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0171
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.42
    Confidence Interval (2-Sided) 95%
    1.35 to 21.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0262
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.71
    Confidence Interval (2-Sided) 95%
    1.20 to 18.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2858
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.88
    Confidence Interval (2-Sided) 95%
    0.59 to 5.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0155
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.65
    Confidence Interval (2-Sided) 95%
    1.47 to 39.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1249
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.66
    Confidence Interval (2-Sided) 95%
    0.76 to 9.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0616
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.85
    Confidence Interval (2-Sided) 95%
    0.94 to 15.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0126
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.32
    Confidence Interval (2-Sided) 95%
    1.58 to 43.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0853
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.10
    Confidence Interval (2-Sided) 95%
    0.85 to 11.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1562
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.56
    Confidence Interval (2-Sided) 95%
    0.70 to 9.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1297
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.83
    Confidence Interval (2-Sided) 95%
    0.74 to 10.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.34
    Confidence Interval (2-Sided) 95%
    0.64 to 8.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0495
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.60
    Confidence Interval (2-Sided) 95%
    1.00 to 73.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1553
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.86
    Confidence Interval (2-Sided) 95%
    0.67 to 12.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.67
    Confidence Interval (2-Sided) 95%
    1.38 to 42.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0472
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.28
    Confidence Interval (2-Sided) 95%
    1.02 to 27.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3736
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    0.51 to 5.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2628
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.58 to 7.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1998
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.43
    Confidence Interval (2-Sided) 95%
    0.63 to 9.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1507
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.89
    Confidence Interval (2-Sided) 95%
    0.68 to 12.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0385
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.92
    Confidence Interval (2-Sided) 95%
    1.10 to 31.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0299
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.85
    Confidence Interval (2-Sided) 95%
    1.26 to 93.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    0.30 to 4.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8532
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.14
    Confidence Interval (2-Sided) 95%
    0.29 to 4.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8823
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.28 to 4.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1651
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.79
    Confidence Interval (2-Sided) 95%
    0.52 to 43.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1048
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.36
    Confidence Interval (2-Sided) 95%
    0.68 to 59.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1168
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.87
    Confidence Interval (2-Sided) 95%
    0.64 to 53.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6936
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.35 to 4.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4315
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.74
    Confidence Interval (2-Sided) 95%
    0.44 to 6.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7936
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    0.31 to 4.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0990
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.30
    Confidence Interval (2-Sided) 95%
    0.71 to 56.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1128
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.86
    Confidence Interval (2-Sided) 95%
    0.66 to 52.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0732
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.36
    Confidence Interval (2-Sided) 95%
    0.83 to 65.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6559
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.39
    Confidence Interval (2-Sided) 95%
    0.33 to 5.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7333
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.80
    Confidence Interval (2-Sided) 95%
    0.21 to 2.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9266
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.24 to 3.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1518
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.04
    Confidence Interval (2-Sided) 95%
    0.55 to 46.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1714
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.69
    Confidence Interval (2-Sided) 95%
    0.51 to 42.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1299
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.60
    Confidence Interval (2-Sided) 95%
    0.60 to 51.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2495
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.75
    Confidence Interval (2-Sided) 95%
    0.49 to 15.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7065
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    0.31 to 5.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7504
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.26
    Confidence Interval (2-Sided) 95%
    0.30 to 5.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7862
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.21 to 3.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1550
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.98
    Confidence Interval (2-Sided) 95%
    0.54 to 45.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1706
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.70
    Confidence Interval (2-Sided) 95%
    0.51 to 42.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1415
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.31
    Confidence Interval (2-Sided) 95%
    0.57 to 49.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1241
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.67
    Confidence Interval (2-Sided) 95%
    0.62 to 51.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2169
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    0.57 to 12.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9982
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.28 to 3.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5364
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.57
    Confidence Interval (2-Sided) 95%
    0.38 to 6.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1210
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.68
    Confidence Interval (2-Sided) 95%
    0.63 to 51.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0726
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.65
    Confidence Interval (2-Sided) 95%
    0.83 to 70.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0749
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.34
    Confidence Interval (2-Sided) 95%
    0.82 to 65.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0530
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.01
    Confidence Interval (2-Sided) 95%
    0.98 to 16.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2134
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.32
    Confidence Interval (2-Sided) 95%
    0.62 to 8.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3688
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.88
    Confidence Interval (2-Sided) 95%
    0.48 to 7.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0563
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.61
    Confidence Interval (2-Sided) 95%
    0.96 to 22.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0935
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.94
    Confidence Interval (2-Sided) 95%
    0.79 to 19.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0901
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.71
    Confidence Interval (2-Sided) 95%
    0.81 to 16.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1366
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.84
    Confidence Interval (2-Sided) 95%
    0.72 to 11.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7876
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    0.34 to 4.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4658
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.59
    Confidence Interval (2-Sided) 95%
    0.45 to 5.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8707
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.25 to 3.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3584
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.89
    Confidence Interval (2-Sided) 95%
    0.49 to 7.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1455
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.13
    Confidence Interval (2-Sided) 95%
    0.67 to 14.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0661
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.07
    Confidence Interval (2-Sided) 95%
    0.90 to 28.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3034
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.97
    Confidence Interval (2-Sided) 95%
    0.54 to 7.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9901
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.01
    Confidence Interval (2-Sided) 95%
    0.28 to 3.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5070
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.55
    Confidence Interval (2-Sided) 95%
    0.42 to 5.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7927
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.21 to 3.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4426
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.44 to 6.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8925
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.23 to 3.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4285
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.79
    Confidence Interval (2-Sided) 95%
    0.42 to 7.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9000
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.31 to 3.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    26. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    15
    34.9%
    25
    55.6%
    30
    69.8%
    30
    66.7%
    33
    75%
    23
    53.5%
    33
    73.3%
    28
    63.6%
    Week 2
    22
    51.2%
    33
    73.3%
    32
    74.4%
    35
    77.8%
    34
    77.3%
    32
    74.4%
    35
    77.8%
    30
    68.2%
    Week 3
    25
    58.1%
    32
    71.1%
    31
    72.1%
    34
    75.6%
    35
    79.5%
    33
    76.7%
    37
    82.2%
    33
    75%
    Week 4
    26
    60.5%
    32
    71.1%
    32
    74.4%
    33
    73.3%
    35
    79.5%
    33
    76.7%
    37
    82.2%
    34
    77.3%
    Week 5
    31
    72.1%
    34
    75.6%
    36
    83.7%
    31
    68.9%
    34
    77.3%
    36
    83.7%
    37
    82.2%
    33
    75%
    Week 6
    30
    69.8%
    33
    73.3%
    33
    76.7%
    30
    66.7%
    33
    75%
    33
    76.7%
    36
    80%
    37
    84.1%
    Week 7
    31
    72.1%
    32
    71.1%
    33
    76.7%
    29
    64.4%
    33
    75%
    32
    74.4%
    34
    75.6%
    37
    84.1%
    Week 8
    32
    74.4%
    33
    73.3%
    33
    76.7%
    31
    68.9%
    31
    70.5%
    33
    76.7%
    35
    77.8%
    32
    72.7%
    Week 9
    30
    69.8%
    32
    71.1%
    33
    76.7%
    31
    68.9%
    33
    75%
    33
    76.7%
    34
    75.6%
    34
    77.3%
    Week 10
    28
    65.1%
    33
    73.3%
    30
    69.8%
    28
    62.2%
    33
    75%
    34
    79.1%
    36
    80%
    34
    77.3%
    Week 11
    30
    69.8%
    32
    71.1%
    31
    72.1%
    26
    57.8%
    32
    72.7%
    34
    79.1%
    36
    80%
    33
    75%
    Week 12
    28
    65.1%
    32
    71.1%
    31
    72.1%
    26
    57.8%
    31
    70.5%
    31
    72.1%
    34
    75.6%
    33
    75%
    Week 13
    16
    37.2%
    25
    55.6%
    22
    51.2%
    20
    44.4%
    21
    47.7%
    22
    51.2%
    21
    46.7%
    26
    59.1%
    Week 14
    15
    34.9%
    21
    46.7%
    21
    48.8%
    14
    31.1%
    18
    40.9%
    19
    44.2%
    19
    42.2%
    22
    50%
    Week 15
    18
    41.9%
    17
    37.8%
    18
    41.9%
    12
    26.7%
    15
    34.1%
    13
    30.2%
    16
    35.6%
    17
    38.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0602
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.96 to 6.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.88
    Confidence Interval (2-Sided) 95%
    1.89 to 12.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.24
    Confidence Interval (2-Sided) 95%
    2.03 to 13.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.07
    Confidence Interval (2-Sided) 95%
    3.23 to 25.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1259
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    0.82 to 5.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.05
    Confidence Interval (2-Sided) 95%
    2.65 to 18.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0070
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.51
    Confidence Interval (2-Sided) 95%
    1.41 to 8.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0193
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.15
    Confidence Interval (2-Sided) 95%
    1.20 to 8.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0148
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.34
    Confidence Interval (2-Sided) 95%
    1.27 to 8.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.05
    Confidence Interval (2-Sided) 95%
    1.83 to 13.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.27
    Confidence Interval (2-Sided) 95%
    2.32 to 22.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0246
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.11
    Confidence Interval (2-Sided) 95%
    1.16 to 8.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.22
    Confidence Interval (2-Sided) 95%
    1.87 to 14.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0825
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.25
    Confidence Interval (2-Sided) 95%
    0.90 to 5.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0542
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.66
    Confidence Interval (2-Sided) 95%
    0.98 to 7.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0837
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.38
    Confidence Interval (2-Sided) 95%
    0.89 to 6.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0131
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.67
    Confidence Interval (2-Sided) 95%
    1.31 to 10.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.34
    Confidence Interval (2-Sided) 95%
    2.41 to 36.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0359
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.10
    Confidence Interval (2-Sided) 95%
    1.08 to 8.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.86
    Confidence Interval (2-Sided) 95%
    1.91 to 17.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0715
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.43
    Confidence Interval (2-Sided) 95%
    0.93 to 6.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0465
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.89
    Confidence Interval (2-Sided) 95%
    1.02 to 8.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0839
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.89 to 6.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0191
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.56
    Confidence Interval (2-Sided) 95%
    1.23 to 10.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.11
    Confidence Interval (2-Sided) 95%
    2.52 to 58.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0593
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.76
    Confidence Interval (2-Sided) 95%
    0.96 to 7.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.95
    Confidence Interval (2-Sided) 95%
    1.63 to 15.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0494
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.75
    Confidence Interval (2-Sided) 95%
    1.00 to 7.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1887
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.15
    Confidence Interval (2-Sided) 95%
    0.69 to 6.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0717
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.06
    Confidence Interval (2-Sided) 95%
    0.91 to 10.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1419
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.43
    Confidence Interval (2-Sided) 95%
    0.74 to 7.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments 0.0141
    Statistical Test of Hypothesis p-Value 0.0141
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.37
    Confidence Interval (2-Sided) 95%
    1.71 to 120.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0775
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.19
    Confidence Interval (2-Sided) 95%
    0.88 to 11.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0283
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.35
    Confidence Interval (2-Sided) 95%
    1.17 to 16.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1767
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.21
    Confidence Interval (2-Sided) 95%
    0.70 to 6.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1675
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    0.72 to 6.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2717
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.84
    Confidence Interval (2-Sided) 95%
    0.62 to 5.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1367
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.40
    Confidence Interval (2-Sided) 95%
    0.76 to 7.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0162
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.53
    Confidence Interval (2-Sided) 95%
    1.62 to 113.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0765
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.23
    Confidence Interval (2-Sided) 95%
    0.88 to 11.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0061
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.80
    Confidence Interval (2-Sided) 95%
    1.79 to 33.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0181
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.40
    Confidence Interval (2-Sided) 95%
    1.33 to 21.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3925
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.53 to 4.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3740
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.66
    Confidence Interval (2-Sided) 95%
    0.54 to 5.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1753
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.33
    Confidence Interval (2-Sided) 95%
    0.69 to 7.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0195
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 12.85
    Confidence Interval (2-Sided) 95%
    1.51 to 109.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1932
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.66 to 8.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0537
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.55
    Confidence Interval (2-Sided) 95%
    0.98 to 12.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0144
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.72
    Confidence Interval (2-Sided) 95%
    1.50 to 39.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6660
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.29
    Confidence Interval (2-Sided) 95%
    0.41 to 4.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7923
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.16
    Confidence Interval (2-Sided) 95%
    0.37 to 3.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3796
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.73
    Confidence Interval (2-Sided) 95%
    0.51 to 5.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0874
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.20
    Confidence Interval (2-Sided) 95%
    0.81 to 21.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1925
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    0.62 to 10.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0651
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.99
    Confidence Interval (2-Sided) 95%
    0.92 to 17.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5361
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.46
    Confidence Interval (2-Sided) 95%
    0.44 to 4.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6258
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.33
    Confidence Interval (2-Sided) 95%
    0.42 to 4.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6275
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    0.43 to 4.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2212
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.21
    Confidence Interval (2-Sided) 95%
    0.62 to 7.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0280
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 11.13
    Confidence Interval (2-Sided) 95%
    1.30 to 95.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0589
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.88
    Confidence Interval (2-Sided) 95%
    0.94 to 25.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0799
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.63
    Confidence Interval (2-Sided) 95%
    0.86 to 15.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1112
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.91
    Confidence Interval (2-Sided) 95%
    0.78 to 10.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0959
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.76
    Confidence Interval (2-Sided) 95%
    0.84 to 9.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3886
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.62
    Confidence Interval (2-Sided) 95%
    0.54 to 4.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0864
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.00
    Confidence Interval (2-Sided) 95%
    0.85 to 10.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0145
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.22
    Confidence Interval (2-Sided) 95%
    1.69 to 119.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0180
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.08
    Confidence Interval (2-Sided) 95%
    1.56 to 110.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0080
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 18.53
    Confidence Interval (2-Sided) 95%
    2.14 to 160.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0236
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.07
    Confidence Interval (2-Sided) 95%
    1.24 to 20.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4303
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.59
    Confidence Interval (2-Sided) 0.4303%
    0.50 to 5.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5529
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.41
    Confidence Interval (2-Sided) 95%
    0.45 to 4.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3268
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.87
    Confidence Interval (2-Sided) 95%
    0.53 to 6.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0343
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.02
    Confidence Interval (2-Sided) 95%
    1.19 to 84.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0391
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.45
    Confidence Interval (2-Sided) 95%
    1.12 to 79.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0187
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 13.31
    Confidence Interval (2-Sided) 95%
    1.54 to 115.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1475
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.60
    Confidence Interval (2-Sided) 95%
    0.71 to 9.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2161
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.19
    Confidence Interval (2-Sided) 95%
    0.63 to 7.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3478
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.79
    Confidence Interval (2-Sided) 95%
    0.53 to 6.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2269
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.22
    Confidence Interval (2-Sided) 95%
    0.61 to 8.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0683
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.66
    Confidence Interval (2-Sided) 95%
    0.89 to 24.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0228
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.11
    Confidence Interval (2-Sided) 95%
    1.31 to 38.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0620
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.95
    Confidence Interval (2-Sided) 95%
    0.93 to 16.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2251
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.18
    Confidence Interval (2-Sided) 95%
    0.62 to 7.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7908
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    0.35 to 3.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3735
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.84
    Confidence Interval (2-Sided) 95%
    0.48 to 7.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1856
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.49
    Confidence Interval (2-Sided) 95%
    0.64 to 9.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.01798
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.67
    Confidence Interval (2-Sided) 95%
    0.64 to 11.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1101
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.19
    Confidence Interval (2-Sided) 95%
    0.77 to 13.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.99
    Confidence Interval (2-Sided) 95%
    0.79 to 11.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5258
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.45 to 4.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8746
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    0.34 to 3.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7434
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    0.24 to 2.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3211
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    0.53 to 6.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5330
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.51
    Confidence Interval (2-Sided) 95%
    0.41 to 5.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1119
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.00
    Confidence Interval (2-Sided) 95%
    0.77 to 11.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3540
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.76
    Confidence Interval (2-Sided) 95%
    0.53 to 5.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5076
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.65
    Confidence Interval (2-Sided) 95%
    0.19 to 2.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5801
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.71
    Confidence Interval (2-Sided) 95%
    0.21 to 2.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2785
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.48
    Confidence Interval (2-Sided) 95%
    0.13 to 1.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5656
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.69
    Confidence Interval (2-Sided) 95%
    0.19 to 2.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6445
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.73
    Confidence Interval (2-Sided) 95%
    0.19 to 2.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7363
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.27
    Confidence Interval (2-Sided) 95%
    0.32 to 4.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3455
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.56
    Confidence Interval (2-Sided) 95%
    0.17 to 1.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    27. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    11
    25.6%
    25
    55.6%
    23
    53.5%
    26
    57.8%
    26
    59.1%
    19
    44.2%
    26
    57.8%
    27
    61.4%
    Week 2
    16
    37.2%
    30
    66.7%
    29
    67.4%
    32
    71.1%
    32
    72.7%
    26
    60.5%
    29
    64.4%
    26
    59.1%
    Week 3
    20
    46.5%
    31
    68.9%
    29
    67.4%
    31
    68.9%
    33
    75%
    28
    65.1%
    36
    80%
    31
    70.5%
    Week 4
    23
    53.5%
    28
    62.2%
    29
    67.4%
    29
    64.4%
    31
    70.5%
    31
    72.1%
    33
    73.3%
    30
    68.2%
    Week 5
    27
    62.8%
    29
    64.4%
    31
    72.1%
    28
    62.2%
    34
    77.3%
    33
    76.7%
    35
    77.8%
    31
    70.5%
    Week 6
    28
    65.1%
    31
    68.9%
    29
    67.4%
    29
    64.4%
    31
    70.5%
    30
    69.8%
    34
    75.6%
    32
    72.7%
    Week 7
    28
    65.1%
    31
    68.9%
    32
    74.4%
    28
    62.2%
    32
    72.7%
    30
    69.8%
    32
    71.1%
    31
    70.5%
    Week 8
    29
    67.4%
    33
    73.3%
    32
    74.4%
    30
    66.7%
    30
    68.2%
    31
    72.1%
    34
    75.6%
    30
    68.2%
    Week 9
    28
    65.1%
    31
    68.9%
    30
    69.8%
    31
    68.9%
    33
    75%
    31
    72.1%
    34
    75.6%
    32
    72.7%
    Week 10
    27
    62.8%
    31
    68.9%
    27
    62.8%
    26
    57.8%
    31
    70.5%
    32
    74.4%
    35
    77.8%
    31
    70.5%
    Week 11
    27
    62.8%
    31
    68.9%
    28
    65.1%
    24
    53.3%
    31
    70.5%
    33
    76.7%
    35
    77.8%
    30
    68.2%
    Week 12
    25
    58.1%
    29
    64.4%
    28
    65.1%
    25
    55.6%
    29
    65.9%
    29
    67.4%
    31
    68.9%
    31
    70.5%
    Week 13
    13
    30.2%
    23
    51.1%
    18
    41.9%
    17
    37.8%
    19
    43.2%
    20
    46.5%
    18
    40%
    21
    47.7%
    Week 14
    14
    32.6%
    19
    42.2%
    16
    37.2%
    11
    24.4%
    16
    36.4%
    18
    41.9%
    15
    33.3%
    17
    38.6%
    Week 15
    15
    34.9%
    15
    33.3%
    12
    27.9%
    10
    22.2%
    14
    31.8%
    13
    30.2%
    11
    24.4%
    13
    29.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.30
    Confidence Interval (2-Sided) 95%
    1.60 to 11.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0057
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.95
    Confidence Interval (2-Sided) 95%
    1.49 to 10.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.03
    Confidence Interval (2-Sided) 95%
    2.26 to 16.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.42
    Confidence Interval (2-Sided) 95%
    2.37 to 17.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1410
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.11
    Confidence Interval (2-Sided) 95%
    0.78 to 5.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.85
    Confidence Interval (2-Sided) 95%
    2.20 to 15.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.50
    Confidence Interval (2-Sided) 95%
    2.08 to 14.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.09
    Confidence Interval (2-Sided) 95%
    1.58 to 10.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.31
    Confidence Interval (2-Sided) 95%
    1.67 to 11.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.26
    Confidence Interval (2-Sided) 95%
    2.63 to 16.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.40
    Confidence Interval (2-Sided) 95%
    3.23 to 27.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0431
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    1.03 to 6.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.40
    Confidence Interval (2-Sided) 95%
    1.72 to 11.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0291
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.76
    Confidence Interval (2-Sided) 95%
    1.11 to 6.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.96
    Confidence Interval (2-Sided) 95%
    1.48 to 10.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0202
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.11
    Confidence Interval (2-Sided) 95%
    1.19 to 8.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.10
    Confidence Interval (2-Sided) 95%
    1.55 to 10.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.21
    Confidence Interval (2-Sided) 95%
    2.89 to 29.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0706
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.43
    Confidence Interval (2-Sided) 95%
    0.93 to 6.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.20
    Confidence Interval (2-Sided) 95%
    2.79 to 24.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0146
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.24
    Confidence Interval (2-Sided) 95%
    1.26 to 8.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0816
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.90 to 6.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0930
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.25
    Confidence Interval (2-Sided) 95%
    0.87 to 5.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.365
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.81
    Confidence Interval (2-Sided) 95%
    1.07 to 7.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.93
    Confidence Interval (2-Sided) 95%
    1.65 to 14.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0488
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.73
    Confidence Interval (2-Sided) 95%
    1.01 to 7.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.85
    Confidence Interval (2-Sided) 95%
    1.43 to 10.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0984
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    0.86 to 5.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2226
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.89
    Confidence Interval (2-Sided) 95%
    0.68 to 5.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1467
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.16
    Confidence Interval (2-Sided) 95%
    0.76 to 6.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0705
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.74
    Confidence Interval (2-Sided) 95%
    0.92 to 8.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 26.62
    Confidence Interval (2-Sided) 95%
    3.16 to 223.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0757
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.75
    Confidence Interval (2-Sided) 95%
    0.90 to 8.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.66
    Confidence Interval (2-Sided) 95%
    1.71 to 18.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0771
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.63
    Confidence Interval (2-Sided) 95%
    0.90 to 7.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1856
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.71 to 5.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5973
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.48 to 3.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0935
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.57
    Confidence Interval (2-Sided) 95%
    0.85 to 7.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0157
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.52
    Confidence Interval (2-Sided) 95%
    1.38 to 22.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1963
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.68 to 6.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0085
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.31
    Confidence Interval (2-Sided) 95%
    1.53 to 18.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1433
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.21
    Confidence Interval (2-Sided) 95%
    0.76 to 6.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1577
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.17
    Confidence Interval (2-Sided) 95%
    0.74 to 6.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1608
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.16
    Confidence Interval (2-Sided) 95%
    0.74 to 6.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0693
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.96
    Confidence Interval (2-Sided) 95%
    0.92 to 9.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.57
    Confidence Interval (2-Sided) 95%
    1.89 to 48.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1637
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.25
    Confidence Interval (2-Sided) 95%
    0.72 to 7.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0326
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.57
    Confidence Interval (2-Sided) 95%
    1.11 to 11.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1455
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.24
    Confidence Interval (2-Sided) 95%
    0.76 to 6.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1951
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.69 to 6.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4097
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.56
    Confidence Interval (2-Sided) 95%
    0.54 to 4.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1554
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    0.73 to 7.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0440
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.22
    Confidence Interval (2-Sided) 95%
    1.04 to 17.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1928
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.23
    Confidence Interval (2-Sided) 95%
    0.67 to 7.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0222
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.67
    Confidence Interval (2-Sided) 95%
    1.25 to 17.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4075
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.58
    Confidence Interval (2-Sided) 95%
    0.54 to 4.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3659
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.65
    Confidence Interval (2-Sided) 95%
    0.56 to 4.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7878
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.41 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0635
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.26
    Confidence Interval (2-Sided) 95%
    0.94 to 11.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0137
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.62
    Confidence Interval (2-Sided) 95%
    1.73 to 123.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1069
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.91
    Confidence Interval (2-Sided) 95%
    0.79 to 10.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0186
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.60
    Confidence Interval (2-Sided) 95%
    1.33 to 23.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1434
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.75 to 7.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1670
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    0.72 to 6.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7810
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.16
    Confidence Interval (2-Sided) 95%
    0.41 to 3.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1682
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.27
    Confidence Interval (2-Sided) 95%
    0.71 to 7.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0215
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.22
    Confidence Interval (2-Sided) 95%
    1.28 to 21.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0306
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.75
    Confidence Interval (2-Sided) 95%
    1.16 to 19.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.10
    Confidence Interval (2-Sided) 95%
    1.92 to 52.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1004
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    0.83 to 8.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1837
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.11
    Confidence Interval (2-Sided) 95%
    0.70 to 6.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5929
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.33
    Confidence Interval (2-Sided) 95%
    0.47 to 3.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2588
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.93
    Confidence Interval (2-Sided) 95%
    0.62 to 6.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0129
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.69
    Confidence Interval (2-Sided) 95%
    1.54 to 38.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0168
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.12
    Confidence Interval (2-Sided) 95%
    1.42 to 35.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 9.95
    Confidence Interval (2-Sided) 95%
    1.94 to 50.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1934
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.08
    Confidence Interval (2-Sided) 95%
    0.69 to 6.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2181
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.01
    Confidence Interval (2-Sided) 95%
    0.66 to 6.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4116
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.58
    Confidence Interval (2-Sided) 95%
    0.53 to 4.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0938
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.84
    Confidence Interval (2-Sided) 95%
    0.84 to 9.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0125
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.02
    Confidence Interval (2-Sided) 95%
    1.57 to 41.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0761
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.29
    Confidence Interval (2-Sided) 95%
    0.88 to 12.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0305
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.02
    Confidence Interval (2-Sided) 95%
    1.14 to 14.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0501
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.42
    Confidence Interval (2-Sided) 95%
    1.00 to 11.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1212
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.61
    Confidence Interval (2-Sided) 95%
    0.78 to 8.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8332
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.13
    Confidence Interval (2-Sided) 95%
    0.35 to 3.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4285
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.66
    Confidence Interval (2-Sided) 95%
    0.48 to 5.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0954
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.98
    Confidence Interval (2-Sided) 95%
    0.83 to 10.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1110
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.98
    Confidence Interval (2-Sided) 95%
    0.78 to 11.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1642
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.44
    Confidence Interval (2-Sided) 95%
    0.69 to 8.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1976
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.19
    Confidence Interval (2-Sided) 95%
    0.66 to 7.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5761
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.40
    Confidence Interval (2-Sided) 95%
    0.43 to 4.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4540
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.64
    Confidence Interval (2-Sided) 95%
    0.20 to 2.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3732
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.57
    Confidence Interval (2-Sided) 95%
    0.17 to 1.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4665
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.59
    Confidence Interval (2-Sided) 95%
    0.46 to 5.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5634
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.46
    Confidence Interval (2-Sided) 95%
    0.41 to 5.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4297
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.65
    Confidence Interval (2-Sided) 95%
    0.48 to 5.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9789
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 95%
    0.31 to 3.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7357
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.81
    Confidence Interval (2-Sided) 95%
    0.24 to 2.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1977
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.46
    Confidence Interval (2-Sided) 95%
    0.14 to 1.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3203
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.52
    Confidence Interval (2-Sided) 95%
    0.14 to 1.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9739
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.30 to 3.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6714
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.33
    Confidence Interval (2-Sided) 95%
    0.36 to 4.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6375
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.22 to 2.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2980
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.54
    Confidence Interval (2-Sided) 95%
    0.17 to 1.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    28. Secondary Outcome
    Title Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
    Description The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
    Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 45 43 43 41 41 44 44
    Week 1
    6
    14%
    19
    42.2%
    22
    51.2%
    23
    51.1%
    22
    50%
    14
    32.6%
    17
    37.8%
    22
    50%
    Week 2
    14
    32.6%
    25
    55.6%
    27
    62.8%
    27
    60%
    25
    56.8%
    24
    55.8%
    27
    60%
    24
    54.5%
    Week 3
    16
    37.2%
    25
    55.6%
    27
    62.8%
    28
    62.2%
    28
    63.6%
    25
    58.1%
    31
    68.9%
    25
    56.8%
    Week 4
    19
    44.2%
    24
    53.3%
    28
    65.1%
    26
    57.8%
    29
    65.9%
    25
    58.1%
    31
    68.9%
    26
    59.1%
    Week 5
    23
    53.5%
    25
    55.6%
    28
    65.1%
    26
    57.8%
    28
    63.6%
    29
    67.4%
    33
    73.3%
    27
    61.4%
    Week 6
    23
    53.5%
    26
    57.8%
    28
    65.1%
    27
    60%
    28
    63.6%
    27
    62.8%
    31
    68.9%
    29
    65.9%
    Week 7
    23
    53.5%
    29
    64.4%
    29
    67.4%
    25
    55.6%
    29
    65.9%
    27
    62.8%
    31
    68.9%
    29
    65.9%
    Week 8
    25
    58.1%
    26
    57.8%
    28
    65.1%
    26
    57.8%
    26
    59.1%
    27
    62.8%
    31
    68.9%
    29
    65.9%
    Week 9
    24
    55.8%
    27
    60%
    29
    67.4%
    26
    57.8%
    29
    65.9%
    27
    62.8%
    32
    71.1%
    29
    65.9%
    Week 10
    22
    51.2%
    27
    60%
    26
    60.5%
    24
    53.3%
    29
    65.9%
    29
    67.4%
    32
    71.1%
    29
    65.9%
    Week 11
    24
    55.8%
    29
    64.4%
    27
    62.8%
    23
    51.1%
    27
    61.4%
    30
    69.8%
    31
    68.9%
    30
    68.2%
    Week 12
    23
    53.5%
    25
    55.6%
    27
    62.8%
    21
    46.7%
    26
    59.1%
    27
    62.8%
    31
    68.9%
    28
    63.6%
    Week 13
    9
    20.9%
    20
    44.4%
    15
    34.9%
    13
    28.9%
    14
    31.8%
    20
    46.5%
    13
    28.9%
    16
    36.4%
    Week 14
    10
    23.3%
    17
    37.8%
    13
    30.2%
    9
    20%
    10
    22.7%
    17
    39.5%
    12
    26.7%
    13
    29.5%
    Week 15
    9
    20.9%
    12
    26.7%
    10
    23.3%
    8
    17.8%
    7
    15.9%
    11
    25.6%
    10
    22.2%
    12
    27.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.35
    Confidence Interval (2-Sided) 95%
    1.69 to 16.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.65
    Confidence Interval (2-Sided) 95%
    2.79 to 26.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.82
    Confidence Interval (2-Sided) 95%
    3.49 to 33.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.01
    Confidence Interval (2-Sided) 95%
    3.20 to 31.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1266
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.51
    Confidence Interval (2-Sided) 95%
    0.77 to 8.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0024
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.72
    Confidence Interval (2-Sided) 95%
    1.85 to 17.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.93
    Confidence Interval (2-Sided) 95%
    2.59 to 24.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0217
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.11
    Confidence Interval (2-Sided) 95%
    1.18 to 8.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.63
    Confidence Interval (2-Sided) 95%
    1.75 to 12.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.72
    Confidence Interval (2-Sided) 95%
    1.80 to 12.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.80
    Confidence Interval (2-Sided) 95%
    1.79 to 12.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0467
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.69
    Confidence Interval (2-Sided) 95%
    1.01 to 7.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.70
    Confidence Interval (2-Sided) 95%
    1.80 to 12.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0234
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.98
    Confidence Interval (2-Sided) 95%
    1.16 to 7.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0294
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.88
    Confidence Interval (2-Sided) 95%
    1.11 to 7.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0068
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.74
    Confidence Interval (2-Sided) 95%
    1.44 to 9.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.35
    Confidence Interval (2-Sided) 95%
    1.68 to 11.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.82
    Confidence Interval (2-Sided) 95%
    2.13 to 15.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0572
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    0.97 to 6.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.03
    Confidence Interval (2-Sided) 95%
    2.28 to 15.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0460
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    1.02 to 6.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1406
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.79 to 5.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0234
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.97
    Confidence Interval (2-Sided) 95%
    1.16 to 7.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0302
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    1.10 to 7.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.23
    Confidence Interval (2-Sided) 95%
    1.87 to 14.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2105
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.82
    Confidence Interval (2-Sided) 95%
    0.71 to 4.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0033
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.17
    Confidence Interval (2-Sided) 95%
    1.61 to 10.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1087
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.10
    Confidence Interval (2-Sided) 95%
    0.85 to 5.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3600
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.56
    Confidence Interval (2-Sided) 95%
    0.60 to 4.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1394
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.05
    Confidence Interval (2-Sided) 95%
    0.79 to 5.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0522
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    0.99 to 7.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0119
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.97
    Confidence Interval (2-Sided) 95%
    1.63 to 11.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1474
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.07
    Confidence Interval (2-Sided) 95%
    0.77 to 5.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.08
    Confidence Interval (2-Sided) 95%
    1.76 to 14.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1263
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.11
    Confidence Interval (2-Sided) 95%
    0.81 to 5.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2327
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 95%
    0.68 to 4.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1359
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.12
    Confidence Interval (2-Sided) 95%
    0.79 to 5.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0258
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.35
    Confidence Interval (2-Sided) 95%
    1.16 to 9.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0076
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.77
    Confidence Interval (2-Sided) 95%
    1.51 to 15.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1088
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.36
    Confidence Interval (2-Sided) 95%
    0.83 to 6.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.89
    Confidence Interval (2-Sided) 95%
    1.64 to 14.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0493
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.74
    Confidence Interval (2-Sided) 95%
    1.00 to 7.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0376
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.99
    Confidence Interval (2-Sided) 95%
    1.06 to 8.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0723
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    0.92 to 6.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0396
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.11
    Confidence Interval (2-Sided) 95%
    1.06 to 9.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.18
    Confidence Interval (2-Sided) 95%
    1.85 to 20.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1044
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.41
    Confidence Interval (2-Sided) 95%
    0.83 to 6.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.47
    Confidence Interval (2-Sided) 95%
    1.78 to 16.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 7
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0364
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.01
    Confidence Interval (2-Sided) 95%
    1.07 to 8.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6396
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.26
    Confidence Interval (2-Sided) 95%
    0.47 to 3.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4378
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.47
    Confidence Interval (2-Sided) 95%
    0.55 to 3.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2045
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.95
    Confidence Interval (2-Sided) 95%
    0.70 to 5.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0958
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.54
    Confidence Interval (2-Sided) 95%
    0.85 to 7.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3210
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.70
    Confidence Interval (2-Sided) 95%
    0.60 to 4.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.75
    Confidence Interval (2-Sided) 95%
    1.23 to 11.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1219
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    0.80 to 6.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2975
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.72
    Confidence Interval (2-Sided) 95%
    0.62 to 4.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2763
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    0.64 to 4.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1235
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.33
    Confidence Interval (2-Sided) 95%
    0.79 to 6.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0190
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.24
    Confidence Interval (2-Sided) 95%
    1.27 to 14.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2213
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.98
    Confidence Interval (2-Sided) 95%
    0.66 to 5.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0050
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.88
    Confidence Interval (2-Sided) 95%
    1.71 to 20.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 9
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1053
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.39
    Confidence Interval (2-Sided) 95%
    0.83 to 6.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0991
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.39
    Confidence Interval (2-Sided) 95%
    0.85 to 6.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2056
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.93
    Confidence Interval (2-Sided) 95%
    0.70 to 5.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0407
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.17
    Confidence Interval (2-Sided) 95%
    1.05 to 9.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.47
    Confidence Interval (2-Sided) 95%
    1.63 to 18.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0230
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.85
    Confidence Interval (2-Sided) 95%
    1.20 to 12.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.36
    Confidence Interval (2-Sided) 95%
    2.14 to 25.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 10
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0248
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.45
    Confidence Interval (2-Sided) 95%
    1.17 to 10.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1091
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    0.82 to 6.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3054
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.61 to 4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1129
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.48
    Confidence Interval (2-Sided) 95%
    0.81 to 7.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0432
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.28
    Confidence Interval (2-Sided) 95%
    1.04 to 10.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0315
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.77
    Confidence Interval (2-Sided) 95%
    1.13 to 12.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0147
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.26
    Confidence Interval (2-Sided) 95%
    1.33 to 13.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 11
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0405
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.18
    Confidence Interval (2-Sided) 95%
    1.05 to 9.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5238
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.40
    Confidence Interval (2-Sided) 95%
    0.50 to 3.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3060
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.73
    Confidence Interval (2-Sided) 95%
    0.60 to 4.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3747
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.64
    Confidence Interval (2-Sided) 95%
    0.55 to 4.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0443
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.49
    Confidence Interval (2-Sided) 95%
    1.03 to 11.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1269
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.49
    Confidence Interval (2-Sided) 95%
    0.77 to 8.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0095
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.15
    Confidence Interval (2-Sided) 95%
    1.49 to 17.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1254
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.34
    Confidence Interval (2-Sided) 95%
    0.79 to 6.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0402
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.66
    Confidence Interval (2-Sided) 95%
    1.06 to 12.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4547
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.59
    Confidence Interval (2-Sided) 95%
    0.47 to 5.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4008
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    0.49 to 5.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1535
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.55
    Confidence Interval (2-Sided) 95%
    0.71 to 9.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0055
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.19
    Confidence Interval (2-Sided) 95%
    1.79 to 28.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2116
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.19
    Confidence Interval (2-Sided) 95%
    0.64 to 7.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 13
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1668
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.34
    Confidence Interval (2-Sided) 95%
    0.70 to 7.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1824
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.32
    Confidence Interval (2-Sided) 95%
    0.67 to 7.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7970
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.85
    Confidence Interval (2-Sided) 95%
    0.25 to 2.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7065
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.21 to 2.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9126
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.29 to 3.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1282
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    0.74 to 10.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2661
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.03
    Confidence Interval (2-Sided) 95%
    0.58 to 7.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 14
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7457
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.22
    Confidence Interval (2-Sided) 95%
    0.36 to 4.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4095
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.73
    Confidence Interval (2-Sided) 95%
    0.47 to 6.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9571
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.04
    Confidence Interval (2-Sided) 95%
    0.28 to 3.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8827
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.23 to 3.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5944
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.69
    Confidence Interval (2-Sided) 95%
    0.17 to 2.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1647
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.74
    Confidence Interval (2-Sided) 95%
    0.66 to 11.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2684
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.07
    Confidence Interval (2-Sided) 95%
    0.57 to 7.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5338
    Comments Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.48
    Confidence Interval (2-Sided) 95%
    0.43 to 5.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    29. Secondary Outcome
    Title Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15
    Description The HFRDIS is a 10-item scale that measures a woman's perceptions of the degree to which VMS interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, and enjoying life); the tenth item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory, which assess the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which VMS had interfered with each item during the previous 2-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score is the average of individual item scores (sum of items/10).
    Time Frame Baseline and weeks 4, 8, 12, and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 42 41 41 38 39 43 40
    Week 4
    -2.2
    (0.34)
    -3.3
    (0.32)
    -3.6
    (0.33)
    -3.8
    (0.33)
    -3.7
    (0.35)
    -2.5
    (0.35)
    -3.4
    (0.32)
    -3.5
    (0.34)
    Week 8
    -2.7
    (0.34)
    -3.3
    (0.33)
    -3.6
    (0.34)
    -4.1
    (0.35)
    -4.2
    (0.36)
    -3.0
    (0.36)
    -3.3
    (0.33)
    -3.6
    (0.35)
    Week 12
    -2.9
    (0.33)
    -3.6
    (0.31)
    -3.8
    (0.33)
    -4.3
    (0.34)
    -4.2
    (0.35)
    -3.3
    (0.35)
    -3.5
    (0.32)
    -3.9
    (0.33)
    Week 15
    -2.4
    (0.39)
    -2.6
    (0.37)
    -2.2
    (0.39)
    -2.3
    (0.40)
    -1.9
    (0.41)
    -2.9
    (0.42)
    -2.4
    (0.38)
    -2.5
    (0.40)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0179
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method Mixed model repeated measures (MMRM)
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.95 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.25 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.50 to -0.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.43 to -0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5806
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.14 to 0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0105
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.03 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.16 to -0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1801
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.52 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0609
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.76 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.33 to -0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.40 to -0.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5519
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.19 to 0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1922
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.51 to 0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0463
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.82 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1288
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.53 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.44
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0577
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.72 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.44
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0027
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.26 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter -1.3
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.20 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4089
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.27 to 0.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2050
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.44 to 0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.44
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0265
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.84 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.44
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7617
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.20 to 0.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6061
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.77 to 1.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7997
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.93 to 1.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3391
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    -0.55 to 1.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.55
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3934
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.55 to 0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.55
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9750
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.00
    Confidence Interval (2-Sided) 95%
    -1.08 to 1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8830
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.13 to 0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    30. Secondary Outcome
    Title Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
    Description The LSEQ is a 10-item self-rated questionnaire that assesses a participants aspects of sleep and early morning behavior. The questions are grouped into 4 chronological areas: ease of getting to sleep, perceived quality of sleep, ease of awaking from sleep, and integrity of early morning behavior following wakefulness. The LSEQ is a visual analog scale that requires respondents to place marks on a group of 10 cm lines. Lines extend between extremes like "more difficult than usual" and "easier than usual." Responses are measured using a 100 mm scale and are averaged to a score for each domain. Higher scores indicates better sleep and better early morning behavior.
    Time Frame Weeks 4, 8, 12, and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 40 41 38 38 38 43 40
    Week 4: Ease of Getting to Sleep
    40.7
    (3.18)
    43.1
    (3.06)
    44.6
    (3.25)
    36.7
    (3.25)
    41.7
    (3.38)
    43.1
    (3.35)
    40.3
    (2.98)
    44.7
    (3.32)
    Week 4: Quality of Sleep
    38.7
    (3.75)
    40.4
    (3.64)
    36.1
    (3.81)
    32.8
    (3.84)
    42.0
    (4.00)
    36.7
    (3.98)
    38.6
    (3.53)
    42.4
    (3.95)
    Week 4: Ease of Awaking From Sleep
    43.6
    (3.31)
    47.1
    (3.18)
    43.9
    (3.36)
    37.8
    (3.38)
    41.7
    (3.53)
    41.8
    (3.51)
    37.5
    (3.10)
    43.3
    (3.48)
    Week 4: Integrity of Behavior Following Awaking
    41.2
    (3.40)
    42.0
    (3.23)
    41.5
    (3.44)
    32.4
    (3.44)
    38.0
    (3.61)
    43.3
    (3.58)
    41.8
    (3.16)
    41.3
    (3.56)
    Week 8:Ease of Getting to Sleep
    40.3
    (3.09)
    39.2
    (2.96)
    41.5
    (3.10)
    35.6
    (3.18)
    38.3
    (3.28)
    41.7
    (3.24)
    43.6
    (2.98)
    43.7
    (3.15)
    Week 8: Quality of Sleep
    41.1
    (3.63)
    36.3
    (3.52)
    39.5
    (3.62)
    33.6
    (3.75)
    38.6
    (3.86)
    36.9
    (3.83)
    37.7
    (3.54)
    38.2
    (3.71)
    Week 8:Ease of Awaking From Sleep
    40.3
    (3.35)
    38.8
    (3.22)
    37.5
    (3.34)
    36.4
    (3.46)
    41.2
    (3.56)
    37.7
    (3.53)
    44.3
    (3.27)
    41.2
    (3.43)
    Week 8: Integrity of Behavior Following Awake
    40.9
    (3.49)
    40.6
    (3.33)
    38.8
    (3.47)
    35.2
    (3.56)
    41.4
    (3.69)
    35.9
    (3.66)
    41.3
    (3.36)
    40.5
    (3.55)
    Wek 12: Ease of Getting Sleep
    32.0
    (3.30)
    37.2
    (3.04)
    38.9
    (3.41)
    37.7
    (3.44)
    39.6
    (3.69)
    39.4
    (3.78)
    41.6
    (3.19)
    38.4
    (3.39)
    Week 12: Quality of Sleep
    36.3
    (3.76)
    37.2
    (3.46)
    38.4
    (3.89)
    36.0
    (3.92)
    34.5
    (4.22)
    37.1
    (4.35)
    37.6
    (3.64)
    36.6
    (3.88)
    Week 12: Ease of Awaking From Sleep
    37.3
    (3.68)
    37.1
    (3.41)
    35.9
    (3.77)
    37.4
    (3.82)
    37.8
    (4.06)
    37.1
    (4.15)
    41.9
    (3.57)
    40.9
    (3.78)
    Week 12: Integrity of Behavior Following Awaking
    35.5
    (3.82)
    38.3
    (3.54)
    36.6
    (3.90)
    37.3
    (3.93)
    41.2
    (4.18)
    35.2
    (4.27)
    44.2
    (3.67)
    39.0
    (3.92)
    Wek 15:Ease of Getting Sleep
    39.8
    (3.62)
    39.2
    (3.29)
    42.8
    (3.51)
    41.5
    (3.59)
    49.4
    (3.91)
    38.8
    (3.85)
    44.8
    (3.45)
    44.0
    (3.64)
    Week 15: Quality of Sleep
    39.3
    (4.54)
    34.7
    (4.19)
    37.1
    (4.39)
    36.2
    (4.52)
    45.9
    (4.95)
    33.0
    (4.88)
    42.4
    (4.39)
    41.4
    (4.60)
    Week 15: Ease of Awaking From Sleep
    33.9
    (4.20)
    34.9
    (3.88)
    37.1
    (4.08)
    36.1
    (4.21)
    45.4
    (4.57)
    35.6
    (4.51)
    49.4
    (4.08)
    45.0
    (4.26)
    Week 15: Integrity of Behavior Following Awaking
    40.9
    (4.15)
    35.1
    (3.81)
    46.7
    (4.01)
    42.8
    (4.11)
    50.9
    (4.48)
    35.9
    (4.43)
    47.1
    (3.98)
    43.8
    (4.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5872
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    -6.09 to 10.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.27
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3779
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.8
    Confidence Interval (2-Sided) 95%
    -4.70 to 12.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.33
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3506
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.1
    Confidence Interval (2-Sided) 95%
    -12.61 to 4.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.34
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8236
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    -7.66 to 9.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.39
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5949
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    -6.24 to 10.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.35
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9237
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -8.65 to 7.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.19
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3599
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    -4.54 to 12.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.32
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7422
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    -8.33 to 11.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.08
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6030
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -12.67 to 7.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.09
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2478
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -16.07 to 4.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.14
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5295
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.3
    Confidence Interval (2-Sided) 95%
    -6.94 to 13.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.18
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6938
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -12.20 to 8.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.16
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9765
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -9.93 to 9.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.97
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4771
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.7
    Confidence Interval (2-Sided) 95%
    -6.45 to 13.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.13
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4256
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.5
    Confidence Interval (2-Sided) 95%
    -5.19 to 12.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.44
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9559
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -8.52 to 9.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.45
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2003
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -14.60 to 3.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.49
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6692
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -10.86 to 6.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.53
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6894
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -10.68 to 7.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.51
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1627
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.1
    Confidence Interval (2-Sided) 95%
    -14.66 to 2.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.35
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9371
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -9.18 to 8.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.48
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8521
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    -8.07 to 9.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.53
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9367
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -8.62 to 9.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.56
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0551
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -8.8
    Confidence Interval (2-Sided) 95%
    -17.82 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.57
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4936
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -3.2
    Confidence Interval (2-Sided) 95%
    -12.32 to 5.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.64
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6404
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.1
    Confidence Interval (2-Sided) 95%
    -6.89 to 11.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.59
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8955
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    -8.17 to 9.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.45
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Integrity of Behavior following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9776
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -8.91 to 9.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.59
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7852
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -9.27 to 7.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.14
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7812
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -7.02 to 9.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.15
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2648
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.7
    Confidence Interval (2-Sided) 95%
    -13.07 to 3.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.23
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6312
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -10.41 to 6.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.25
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7416
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    -6.89 to 9.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.20
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4254
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.3
    Confidence Interval (2-Sided) 95%
    -4.83 to 11.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.12
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4038
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.4
    Confidence Interval (2-Sided) 95%
    -4.66 to 11.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.11
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3270
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -14.49 to 4.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.91
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7333
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -11.21 to 7.90
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.85
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1319
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -7.5
    Confidence Interval (2-Sided) 95%
    -17.36 to 2.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.99
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6132
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -12.38 to 7.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.00
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4024
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -13.98 to 5.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.98
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4904
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.4
    Confidence Interval (2-Sided) 95%
    -12.97 to 6.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.88
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5521
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -12.48 to 6.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.87
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7370
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -10.38 to 7.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.50
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5269
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -11.62 to 5.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.46
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3937
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.9
    Confidence Interval (2-Sided) 95%
    -12.93 to 5.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.58
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8460
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    -8.15 to 9.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.59
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5673
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -11.62 to 6.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.57
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3791
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    -4.88 to 12.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.49
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8340
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    -7.86 to 9.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.47
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9457
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -9.51 to 8.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.67
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6570
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -11.22 to 7.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.65
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2310
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.7
    Confidence Interval (2-Sided) 95%
    -15.00 to 3.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.73
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9066
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    -8.84 to 9.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.77
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2914
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differnce
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -14.26 to 4.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.71
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9277
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -8.73 to 9.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.64
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9367
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -9.51 to 8.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.64
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2407
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 5.1
    Confidence Interval (2-Sided) 95%
    -3.46 to 13.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.35
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1305
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.9
    Confidence Interval (2-Sided) 95%
    -2.06 to 15.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.55
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2152
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 5.7
    Confidence Interval (2-Sided) 95%
    -3.34 to 14.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.59
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1099
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 7.6
    Confidence Interval (2-Sided) 95%
    -1.73 to 16.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.72
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1219
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 7.4
    Confidence Interval (2-Sided) 95%
    -1.99 to 16.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.75
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0316
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 9.6
    Confidence Interval (2-Sided) 95%
    0.85 to 18.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.44
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1557
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.4
    Confidence Interval (2-Sided) 95%
    -2.44 to 15.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.47
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8592
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    -8.91 to 10.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.97
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6891
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.1
    Confidence Interval (2-Sided) 95%
    -8.08 to 12.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.15
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9481
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -10.59 to 9.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.20
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7246
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -12.46 to 8.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.36
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8842
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    -9.94 to 11.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.45
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8103
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -8.74 to 11.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.05
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9631
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -9.81 to 10.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.10
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9788
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -9.73 to 9.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.87
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7875
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -11.26 to 8.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.02
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9746
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -9.85 to 10.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.08
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9092
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    -9.67 to 10.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.21
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9745
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -10.55 to 10.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.27
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3458
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 4.7
    Confidence Interval (2-Sided) 95%
    -5.08 to 14.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.95
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4657
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differnce
    Estimated Value 3.6
    Confidence Interval (2-Sided) 95%
    -6.17 to 13.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.98
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5838
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.8
    Confidence Interval (2-Sided) 95%
    -7.20 to 12.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.07
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8322
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.1
    Confidence Interval (2-Sided) 95%
    -9.18 to 11.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.22
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7366
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.8
    Confidence Interval (2-Sided) 95%
    -8.59 to 12.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.26
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2971
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 5.6
    Confidence Interval (2-Sided) 95%
    -4.99 to 16.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.40
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9562
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -10.96 to 10.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.41
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0926
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter 0.28
    Estimated Value 8.7
    Confidence Interval (2-Sided) 95%
    -1.44 to 18.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.13
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4996
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.5
    Confidence Interval (2-Sided) 95%
    -6.70 to 13.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.18
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8960
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -9.99 to 8.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.76
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5471
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.9
    Confidence Interval (2-Sided) 95%
    -6.68 to 12.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.89
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7380
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    -8.06 to 11.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.93
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0644
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 9.6
    Confidence Interval (2-Sided) 95%
    -0.58 to 19.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.14
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8475
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -10.90 to 8.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.04
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3044
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 5.0
    Confidence Interval (2-Sided) 95%
    -4.57 to 14.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.86
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Ease of Getting to Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3895
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 4.2
    Confidence Interval (2-Sided) 95%
    -5.42 to 13.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.89
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4551
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.5
    Confidence Interval (2-Sided) 95%
    -16.50 to 7.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.07
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7182
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -14.21 to 9.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.10
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6259
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -15.26 to 9.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.21
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3120
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.6
    Confidence Interval (2-Sided) 95%
    -6.22 to 19.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.50
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3297
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -6.3
    Confidence Interval (2-Sided) 95%
    -18.89 to 6.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.41
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6130
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.1
    Confidence Interval (2-Sided) 95%
    -9.02 to 15.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.16
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Quality of Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7292
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.2
    Confidence Interval (2-Sided) 95%
    -10.09 to 14.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.22
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8695
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    -1.11 to 11.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.60
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5800
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 3.1
    Confidence Interval (2-Sided) 95%
    -7.99 to 14.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.64
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7024
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.2
    Confidence Interval (2-Sided) 95%
    -9.11 to 13.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.74
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0572
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 11.4
    Confidence Interval (2-Sided) 95%
    -0.35 to 23.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.99
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7830
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    -10.04 to 13.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.93
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0074
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter 0.1
    Estimated Value 15.4
    Confidence Interval (2-Sided) 95%
    4.19 to 26.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.71
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Ease of Awaking From Sleep
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0551
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 11.0
    Confidence Interval (2-Sided) 95%
    -0.24 to 22.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.73
    Estimation Comments
    Statistical Analysis 106
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2959
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -16.63 to 5.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.51
    Estimation Comments
    Statistical Analysis 107
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2976
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 5.8
    Confidence Interval (2-Sided) 95%
    -5.14 to 16.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.55
    Estimation Comments
    Statistical Analysis 108
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7236
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -9.07 to 13.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.62
    Estimation Comments
    Statistical Analysis 109
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0884
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 10.1
    Confidence Interval (2-Sided) 95%
    -1.52 to 21.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.88
    Estimation Comments
    Statistical Analysis 110
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3887
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -16.35 to 6.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.77
    Estimation Comments
    Statistical Analysis 111
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2671
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 6.2
    Confidence Interval (2-Sided) 95%
    -4.80 to 17.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.59
    Estimation Comments
    Statistical Analysis 112
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Integrity of Behavior Following Awaking
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6076
    Comments LSM, SE, CI, & p-values come from an MMRM model with domain score as dependent variable & TG, visit & smoking status as factors & baseline measurement (BM) as a covariate, as well as interaction of treatment by week & an interaction of BM by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 2.9
    Confidence Interval (2-Sided) 95%
    -8.20 to 13.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.63
    Estimation Comments
    31. Secondary Outcome
    Title Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
    Description The GCS is a 21-item scale that provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item is rated by the participant according to its severity using a 4-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into 3 main independent symptom measures by summing up the individual item scores: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and VMS (items 19 to 20; score 0 to 6). Item 21 is a probe for sexual dysfunction. The total score can range from 0 to 63. Higher scores indicate worse symptoms.
    Time Frame Baseline and weeks 4, 8, 12, and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 42 41 41 39 40 43 40
    Week 4: Psychological Symptoms
    -2.6
    (0.70)
    -3.8
    (0.66)
    -4.5
    (0.69)
    -5.0
    (0.68)
    -4.4
    (0.71)
    -3.7
    (0.70)
    -2.1
    (0.65)
    -4.9
    (0.71)
    Week 4: Physical Symptoms
    -1.1
    (0.38)
    -1.1
    (0.37)
    -1.6
    (0.38)
    -1.1
    (0.37)
    -1.2
    (0.39)
    -1.4
    (0.39)
    -0.8
    (0.36)
    -1.9
    (0.39)
    Week 4: VasomotorSymptoms Score
    -1.7
    (0.27)
    -2.1
    (0.25)
    -2.7
    (0.26)
    -3.3
    (0.26)
    -3.2
    (0.27)
    -2.2
    (0.27)
    -2.6
    (0.25)
    -2.9
    (0.27)
    Week 4: Sexual Dysfunction Score
    -0.4
    (0.13)
    -0.7
    (0.12)
    -0.7
    (0.13)
    -0.9
    (0.13)
    -0.7
    (0.13)
    -0.3
    (0.13)
    -0.4
    (0.12)
    -0.6
    (0.13)
    Week 4: Total Score
    -6.1
    (1.17)
    -7.8
    (1.10)
    -9.6
    (1.16)
    -10.4
    (1.15)
    -9.5
    (1.19)
    -7.6
    (1.19)
    -5.8
    (1.10)
    -10.3
    (1.19)
    Week 8: Psychological Symptoms
    -3.3
    (0.71)
    -5.0
    (0.69)
    -4.7
    (0.71)
    -4.9
    (0.73)
    -4.5
    (0.74)
    -3.3
    (0.73)
    -2.8
    (0.69)
    -4.6
    (0.73)
    Week 8: Physical Symptoms
    -1.1
    (0.40)
    -1.5
    (0.39)
    -1.3
    (0.40)
    -0.8
    (0.40)
    -1.6
    (0.41)
    -1.4
    (0.41)
    -0.9
    (0.39)
    -1.9
    (0.40)
    Week 8: VasomotorSymptoms Score
    -1.9
    (0.27)
    -2.5
    (0.26)
    -3.0
    (0.27)
    -3.4
    (0.28)
    -3.5
    (0.28)
    -2.2
    (0.28)
    -2.9
    (0.26)
    -3.0
    (0.28)
    Week 8: Sexual Dysfunction Score
    -0.4
    (0.14)
    -0.5
    (0.13)
    -0.8
    (0.14)
    -0.7
    (0.14)
    -0.6
    (0.14)
    -0.6
    (0.14)
    -0.3
    (0.13)
    -0.8
    (0.14)
    Week 8: Total Score
    -6.9
    (1.23)
    -9.4
    (1.18)
    -9.9
    (1.21)
    -9.9
    (1.25)
    -10.1
    (1.27)
    -7.6
    (1.26)
    -7.0
    (1.18)
    -10.2
    (1.24)
    Week 12: Psychological Symptoms
    -3.3
    (0.73)
    -5.0
    (0.68)
    -4.9
    (0.73)
    -4.8
    (0.75)
    -4.3
    (0.77)
    -4.4
    (0.77)
    -3.6
    (0.70)
    -4.9
    (0.74)
    Week 12: Physical Symptoms Score
    -1.5
    (0.38)
    -2.1
    (0.36)
    -1.0
    (0.39)
    -1.3
    (0.40)
    -1.6
    (0.41)
    -1.7
    (0.41)
    -0.9
    (0.37)
    -1.9
    (0.39)
    Week 12: Vasomotor Symptoms Score
    -2.1
    (0.26)
    -2.7
    (0.24)
    -3.1
    (0.26)
    -3.6
    (0.26)
    -3.6
    (0.27)
    -2.9
    (0.27)
    -2.8
    (0.25)
    -2.9
    (0.26)
    Week 12: Sexual Dysfunction Score
    -0.5
    (0.14)
    -0.7
    (0.13)
    -1.1
    (0.14)
    -0.9
    (0.15)
    -0.8
    (0.15)
    -0.5
    (0.15)
    -0.5
    (0.14)
    -0.6
    (0.14)
    Week 12: Total Score
    -7.6
    (1.23)
    -10.4
    (1.15)
    -10.1
    (1.23)
    -10.7
    (1.25)
    -10.3
    (1.29)
    -9.6
    (1.29)
    -7.8
    (1.18)
    -10.3
    (1.24)
    Week 15: Psychological Symptoms Score ;
    -2.7
    (0.82)
    -4.6
    (0.76)
    -4.3
    (0.79)
    -2.7
    (0.82)
    -2.3
    (0.83)
    -4.4
    (0.84)
    -2.6
    (0.79)
    -4.1
    (0.82)
    Week 15: Physical Symptoms Score
    -1.4
    (0.43)
    -1.7
    (0.40)
    -1.8
    (0.42)
    -1.0
    (0.42)
    -1.4
    (0.43)
    -1.4
    (0.44)
    -1.2
    (0.41)
    -2.1
    (0.43)
    Week 15: Vasomotor Symptoms Score
    -1.4
    (0.34)
    -2.1
    (0.32)
    -1.6
    (0.33)
    -1.7
    (0.34)
    -1.9
    (0.35)
    -1.9
    (0.35)
    -1.8
    (0.33)
    -1.5
    (0.34)
    Week 15: Sexual Dysfunction Score
    -0.5
    (0.15)
    -0.7
    (0.14)
    -0.6
    (0.15)
    -0.7
    (0.15)
    -0.5
    (0.15)
    -0.7
    (0.16)
    -0.6
    (0.15)
    -0.7
    (0.15)
    Week 15: Total Score
    -6.3
    (1.41)
    -9.1
    (1.31)
    -8.3
    (1.37)
    -6.3
    (1.41)
    -6.0
    (1.43)
    -8.6
    (1.44)
    -6.3
    (1.36)
    -8.3
    (1.41)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2159
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.93 to 0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.91
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0405
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.70 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.92
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0115
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -4.18 to -0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.93
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0553
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.62 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.93
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2753
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.82 to 0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.92
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5140
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    -1.20 to 2.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.91
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0178
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -4.03 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.93
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9675
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -1.02 to 0.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3122
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.52 to 0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9977
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.00 to 1.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9312
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -1.05 to 0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6005
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.27 to 0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5284
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.68 to 1.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1111
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.82 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1764
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.16 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Vasomotor Symptoms
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.73 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.30 to -0.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.21 to -0.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1444
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.21 to 0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0088
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.60 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -1.93 to -0.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0416
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.69 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0353
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.71 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0495
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.69 to -0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8665
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.31 to 0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9303
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.35 to 0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1039
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.62 to 0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.17
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2547
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -4.78 to 1.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.54
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0225
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.6
    Confidence Interval (2-Sided) 95%
    -6.60 to -0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.55
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -4.3
    Confidence Interval (2-Sided) 95%
    -7.38 to -1.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.55
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0301
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.4
    Confidence Interval (2-Sided) 95%
    -6.48 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.56
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3220
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -4.59 to 1.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.55
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8782
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -2.80 to 3.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.54
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0069
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -7.27 to -1.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.55
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0890
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.49 to 0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.95
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1444
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -3.25 to 0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.95
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1022
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.51 to 0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.97
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2342
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -3.07 to 0.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.97
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9906
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -1.89 to 1.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.96
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5770
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    -1.34 to 2.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.95
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1865
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -3.14 to 0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.95
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4575
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.45 to 0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6016
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.33 to 0.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7026
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.86 to 1.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2971
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.64 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5491
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.38 to 0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7142
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.86 to 1.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1157
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.89 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1114
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.30 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.83 to -0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Vasomotor Symptoms Scre
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.20 to -0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.37
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5093
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.96 to 0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.37
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.33 to -0.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.37
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0090
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.67 to -0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0024
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.84 to -0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.37
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5497
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.47 to 0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0276
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.76 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1274
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.65 to 0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1865
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method LSMean difference
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1857
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8631
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0304
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.75 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.18
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1246
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -5.71 to 0.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.63
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0680
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -6.19 to 0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.63
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0729
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -6.28 to 0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.67
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0541
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.2
    Confidence Interval (2-Sided) 95%
    -6.49 to 0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.66
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6960
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -3.87 to 2.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.64
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9725
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -3.27 to 3.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.63
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0419
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.3
    Confidence Interval (2-Sided) 95%
    -6.53 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.63
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0794
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.57 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.96
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1153
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -3.47 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.98
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1334
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter -1.5
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -3.47 to 0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.00
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3457
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.93 to 1.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.00
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2607
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -3.07 to 0.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.99
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7816
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -2.18 to 1.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.97
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0955
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -3.54 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.97
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2582
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.57 to 0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3448
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    -0.53 to 1.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.52
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6587
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.81 to 1.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8299
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.16 to 0.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8129
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.17 to 0.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2130
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    -0.37 to 1.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.52
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4131
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.42 to 0.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1273
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.20 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.34
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.69 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.19 to -0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.19 to -0.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0333
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.45 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0423
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.39 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0208
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.49 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3435
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.55 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.98 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0408
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.79 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0911
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.73 to 0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7891
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.44 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9973
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.38 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6377
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter -0.1
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.47 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0862
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -5.95 to 0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.61
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1305
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -5.74 to 0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.65
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0707
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -6.34 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.68
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1232
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -5.92 to 0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.68
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2530
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -5.18 to 1.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.66
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9133
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -3.40 to 3.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.64
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1078
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -5.85 to 0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.63
    Estimation Comments
    Statistical Analysis 106
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0719
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -4.07 to 0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.08
    Estimation Comments
    Statistical Analysis 107
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1298
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.80 to 0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.09
    Estimation Comments
    Statistical Analysis 108
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9532
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -2.26 to 2.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.11
    Estimation Comments
    Statistical Analysis 109
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7510
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -1.84 to 2.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.12
    Estimation Comments
    Statistical Analysis 110
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1120
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -3.95 to 0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.11
    Estimation Comments
    Statistical Analysis 111
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9781
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -2.13 to 2.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.10
    Estimation Comments
    Statistical Analysis 112
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Psychological Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2060
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -3.57 to 0.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.10
    Estimation Comments
    Statistical Analysis 113
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5332
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.46 to 0.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments
    Statistical Analysis 114
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4599
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.54 to 0.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.57
    Estimation Comments
    Statistical Analysis 115
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4752
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.72 to 1.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    Statistical Analysis 116
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9051
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.21 to 1.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    Statistical Analysis 117
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9937
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.14 to 1.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    Statistical Analysis 118
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6956
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.91 to 1.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.57
    Estimation Comments
    Statistical Analysis 119
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2302
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.81 to 0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.57
    Estimation Comments
    Statistical Analysis 120
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1544
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.55 to 0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 121
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6847
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.10 to 0.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.46
    Estimation Comments
    Statistical Analysis 122
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5520
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.20 to 0.64
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 123
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3632
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.36 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 124
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2828
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.43 to 0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 125
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4702
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.24 to 0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 126
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Vasomotor Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8262
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.02 to 0.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.47
    Estimation Comments
    Statistical Analysis 127
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3152
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.60 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 128
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4399
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.56 to 0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 129
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1898
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.67 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 130
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9791
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.40 to 0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 131
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3178
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.21
    Estimation Comments
    Statistical Analysis 132
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4174
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.57 to 0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 133
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Sexual Dysfunction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2490
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.63 to 0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.20
    Estimation Comments
    Statistical Analysis 134
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1233
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -6.57 to 0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.87
    Estimation Comments
    Statistical Analysis 135
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2858
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -5.76 to 1.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    Statistical Analysis 136
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9716
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -3.87 to 3.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 137
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9072
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -3.58 to 4.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 138
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2334
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -6.07 to 1.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.92
    Estimation Comments
    Statistical Analysis 139
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9859
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -3.79 to 3.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.91
    Estimation Comments
    Statistical Analysis 140
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Total Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2870
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable &TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & an interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -5.77 to 1.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.90
    Estimation Comments
    32. Secondary Outcome
    Title Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
    Description The MENQoL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of 1 of 4 domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1 to 8. Higher scores indicate that menopause symptoms are more bothersome.
    Time Frame Baseline and weeks 4, 8, 12, and 15

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 42 42 41 41 39 40 43 40
    Week 4: Vasomotor Mean Score
    -1.8
    (0.32)
    -2.4
    (0.30)
    -3.0
    (0.32)
    -3.4
    (0.31)
    -3.6
    (0.32)
    -1.9
    (0.32)
    -2.4
    (0.30)
    -2.8
    (0.32)
    Week 4:Psychological Mean Score
    -1.0
    (0.21)
    -1.2
    (0.20)
    -1.3
    (0.21)
    -1.3
    (0.20)
    -1.2
    (0.21)
    -0.8
    (0.21)
    -0.6
    (0.20)
    -1.0
    (0.21)
    Week 4: Physical Mean Score
    -0.8
    (0.18)
    -1.2
    (0.17)
    -1.4
    (0.18)
    -1.1
    (0.18)
    -1.3
    (0.19)
    -1.1
    (0.19)
    -0.8
    (0.17)
    -1.3
    (0.19)
    Week 4: Sexual Mean Score
    -0.7
    (0.27)
    -1.5
    (0.25)
    -1.8
    (0.27)
    -1.4
    (0.26)
    -1.2
    (0.27)
    -0.8
    (0.28)
    -0.7
    (0.25)
    -1.2
    (0.27)
    Week 4: Overall Mean Score
    -0.9
    (0.18)
    -1.3
    (0.17)
    -1.6
    (0.18)
    -1.4
    (0.17)
    -1.5
    (0.18)
    -1.1
    (0.18)
    -0.9
    (0.17)
    -1.3
    (0.18)
    Week 8: Vasomotor Mean Score
    -2.1
    (0.31)
    -2.6
    (0.30)
    -3.4
    (0.31)
    -3.8
    (0.31)
    -4.1
    (0.32)
    -2.5
    (0.32)
    -3.1
    (0.30)
    -3.4
    (0.32)
    Week 8: Psychological Mean Score
    -1.2
    (0.20)
    -1.2
    (0.19)
    -1.3
    (0.20)
    -1.4
    (0.20)
    -1.3
    (0.21)
    -1.0
    (0.20)
    -1.0
    (0.19)
    -1.1
    (0.20)
    Week 8: Physical Mean Score
    -1.0
    (0.19)
    -1.2
    (0.18)
    -1.5
    (0.19)
    -1.4
    (0.19)
    -1.5
    (0.19)
    -1.3
    (0.19)
    -1.0
    (0.18)
    -1.3
    (0.19)
    Week 8: Sexual Mean Score
    -0.9
    (0.26)
    -1.0
    (0.25)
    -1.7
    (0.26)
    -1.2
    (0.27)
    -1.2
    (0.27)
    -1.3
    (0.27)
    -0.8
    (0.25)
    -1.2
    (0.27)
    Week 8: Overall Mean Score
    -1.2
    (0.18)
    -1.3
    (0.17)
    -1.7
    (0.18)
    -1.6
    (0.18)
    -1.7
    (0.18)
    -1.4
    (0.18)
    -1.2
    (0.17)
    -1.5
    (0.18)
    Week 12: Vasomotor Mean Score
    -2.3
    (0.31)
    -3.2
    (0.29)
    -3.5
    (0.31)
    -3.8
    (0.31)
    -4.4
    (0.32)
    -2.9
    (0.32)
    -3.3
    (0.30)
    -3.6
    (0.31)
    Week 12: Psychological Mean Score
    -1.3
    (0.20)
    -1.3
    (0.19)
    -1.7
    (0.20)
    -1.5
    (0.21)
    -1.4
    (0.22)
    -1.0
    (0.22)
    -1.1
    (0.20)
    -1.2
    (0.21)
    Week 12: Physical Mean Score
    -1.3
    (0.19)
    -1.4
    (0.18)
    -1.6
    (0.19)
    -1.4
    (0.19)
    -1.5
    (0.20)
    -1.4
    (0.20)
    -1.0
    (0.18)
    -1.4
    (0.19)
    Week 12: Sexual Score
    -0.8
    (0.29)
    -0.9
    (0.27)
    -1.8
    (0.29)
    -1.4
    (0.29)
    -0.9
    (0.30)
    -1.4
    (0.31)
    -0.8
    (0.28)
    -1.3
    (0.29)
    Week 12: Overall Mean Score
    -1.3
    (0.18)
    -1.5
    (0.17)
    -1.8
    (0.18)
    -1.7
    (0.18)
    -1.7
    (0.19)
    -1.5
    (0.19)
    -1.3
    (0.17)
    -1.6
    (0.18)
    Week 15: Vasomotor Mean Score
    -1.8
    (0.36)
    -2.1
    (0.34)
    -1.7
    (0.36)
    -1.4
    (0.37)
    -1.7
    (0.37)
    -2.1
    (0.38)
    -2.2
    (0.35)
    -1.3
    (0.37)
    Week 15: Psychological Mean Score
    -1.0
    (0.23)
    -1.0
    (0.22)
    -1.3
    (0.23)
    -1.1
    (0.23)
    -0.9
    (0.24)
    -1.2
    (0.24)
    -0.9
    (0.22)
    -1.0
    (0.23)
    Week 15: Physical Mean Score
    -1.2
    (0.20)
    -1.3
    (0.18)
    -1.5
    (0.19)
    -0.9
    (0.20)
    -1.2
    (0.20)
    -1.4
    (0.20)
    -1.0
    (0.19)
    -1.2
    (0.20)
    Week 15: Sexual Mean Score
    -0.6
    (0.30)
    -0.9
    (0.28)
    -1.5
    (0.30)
    -1.4
    (0.30)
    -0.6
    (0.31)
    -1.3
    (0.32)
    -0.6
    (0.29)
    -1.2
    (0.30)
    Week 15: Overall Mean Score
    -1.1
    (0.19)
    -1.3
    (0.18)
    -1.5
    (0.19)
    -1.1
    (0.19)
    -1.2
    (0.20)
    -1.4
    (0.21)
    -1.0
    (0.19)
    -1.2
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1632
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.41 to 0.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.03 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.43 to -0.77
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -2.70 to -1.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8569
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.91 to 0.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1110
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.49 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0187
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.83 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4972
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.73 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2568
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.86 to 0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2609
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.86 to 0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4148
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.78 to 0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5575
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.38 to 0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1671
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.16 to 0.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9462
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.57 to 0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0699
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.91 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0056
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.15 to -0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1117
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.86 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0265
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.02 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1119
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.86 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7607
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.54 to 0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0437
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.97 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0211
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.51 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.82 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0598
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.37 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1573
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.21 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7257
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.83 to 0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9324
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.72 to 0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2172
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.14 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 4: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0742
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.88 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 4: Overall Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.16 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 4: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0266
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 4: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0124
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 4: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4367
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.65 to 0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 4: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9318
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.48 to 0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 4: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0714
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.89 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2027
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.35 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.16 to -0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -2.53 to -0.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -2.83 to -1.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3791
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.19 to 0.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0211
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.78 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.10 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Wek 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8890
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.55 to 0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5568
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.67 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3989
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.75 to 0.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6094
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.66 to 0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5229
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.35 to 0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4409
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.31 to 0.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8062
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.45 to 0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3663
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.71 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0424
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1597
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.85 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0595
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.97 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Physical Symptoms Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2162
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differnce
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9833
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.49 to 0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2034
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.81 to 0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9576
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.70 to 0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0410
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.40 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3961
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.00 to 0.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5012
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.94 to 0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.36
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2592
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.10 to 0.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6141
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.51 to 0.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4390
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.95 to 0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.35
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 8: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4521
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.64 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 8: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0257
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 8: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0564
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.93 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Wek 8: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0293
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 8: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3742
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.68 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 8: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9106
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.49 to 0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 8: Overall Mean SCore
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1844
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.78 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0287
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.69 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.05 to -0.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.32 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -2.87 to -1.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1826
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.38 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.42
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0178
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.79 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differnce
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.06 to -0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9163
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.55 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1597
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.92 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4871
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.74 to 0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5401
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.72 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3788
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.30 to 0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.28
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4541
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter 0.28
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9233
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.51 to 0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6043
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1781
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.82 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5221
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.66 to 0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4744
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.68 to 0.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5167
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.66 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3441
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.25 to 0.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5362
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.64 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.25
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9349
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.78 to 0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.38
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0084
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.78 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.39
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1212
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.38 to 0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.39
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7709
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.89 to 0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.39
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1667
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.33 to 0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9213
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.72 to 0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.38
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2315
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.21 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.38
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4731
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.63 to 0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0310
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.98 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1320
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.84 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1212
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.85 to 0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5689
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.62 to 0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7340
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter 0.1
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.39 to 0.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 12: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2704
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.73 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 106
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5610
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.24 to 0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.48
    Estimation Comments
    Statistical Analysis 107
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7966
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.83 to 1.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.49
    Estimation Comments
    Statistical Analysis 108
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3965
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.56 to 1.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    Statistical Analysis 109
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8189
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.87 to 1.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    Statistical Analysis 110
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 12: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5693
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.27 to 0.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    Statistical Analysis 111
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5217
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.29 to 0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.49
    Estimation Comments
    Statistical Analysis 112
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Vasomotor Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2988
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    -0.46 to 1.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.49
    Estimation Comments
    Statistical Analysis 113
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7957
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.69 to 0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.31
    Estimation Comments
    Statistical Analysis 114
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2540
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.97 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.31
    Estimation Comments
    Statistical Analysis 115
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6956
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.75 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.32
    Estimation Comments
    Statistical Analysis 116
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8694
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.57 to 0.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.32
    Estimation Comments
    Statistical Analysis 117
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5047
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.84 to 0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.32
    Estimation Comments
    Statistical Analysis 118
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7515
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.52 to 0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.31
    Estimation Comments
    Statistical Analysis 119
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Psychological Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7818
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.70 to 0.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.31
    Estimation Comments
    Statistical Analysis 120
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5770
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.65 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 121
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1893
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.85 to 0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 122
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2997
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.25 to 0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 123
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7529
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.60 to 0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 124
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4173
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.73 to 0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 125
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4944
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.34 to 0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 126
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Physical Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9231
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.54 to 0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 127
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5112
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean differencce
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.04 to 0.52
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments
    Statistical Analysis 128
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0300
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.66 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments
    Statistical Analysis 129
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0634
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.57 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 130
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9406
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.78 to 0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 131
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1168
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.46 to 0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    Statistical Analysis 132
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9937
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.79 to 0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments
    Statistical Analysis 133
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Sexual Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1858
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.32 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments
    Statistical Analysis 134
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 15 mg BID
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5765
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.65 to 0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 135
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg BID
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1848
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.86 to 0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 136
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg BID
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7299
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.43 to 0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 137
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 90 mg BID
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9415
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.54 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 138
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 30 mg QD
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2742
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.82 to 0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.27
    Estimation Comments
    Statistical Analysis 139
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 60 mg QD
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6946
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.41 to 0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    Statistical Analysis 140
    Statistical Analysis Overview Comparison Group Selection Placebo BID, Fezolinetant 120 mg QD
    Comments Week 15: Overall Mean Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9442
    Comments LSM, SE, CI, & p-values come from an MMRM model with CFB as dependent variable & TG, visit & smoking status as factors & baseline measurement as a covariate, as well as interaction of treatment by week & interaction of baseline measurement by week.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LSMean difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -0.53 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    33. Secondary Outcome
    Title Change Over Time From Baseline in Plasma Concentrations of Luteinizing Hormone (LH) at Week 12
    Description Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.
    Time Frame Baseline and week 12

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at baseline and specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 37 40 33 30 28 28 35 36
    Mean (Standard Deviation) [International unit per liter (IU/L)]
    -1.14
    (8.00)
    -1.28
    (8.53)
    -3.28
    (8.93)
    -7.30
    (15.49)
    -10.86
    (12.64)
    -3.69
    (11.21)
    -3.97
    (9.55)
    -8.62
    (11.95)
    34. Secondary Outcome
    Title Change Over Time From Baseline in Plasma Concentrations of Follicle-Stimulating Hormone (FSH) at Week 12
    Description Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.
    Time Frame Baseline and week 12

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at baseline and specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 37 40 33 30 28 28 35 36
    Mean (Standard Deviation) [IU/L]
    -0.91
    (9.79)
    -1.52
    (12.88)
    -1.00
    (13.51)
    -6.49
    (25.58)
    -9.43
    (17.40)
    -0.98
    (26.90)
    -0.07
    (8.97)
    -9.94
    (16.96)
    35. Secondary Outcome
    Title Change Over Time From Baseline in Plasma Concentrations of Estradiol (E2) at Week 12
    Description Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. The analysis value for Estradiol was imputed as 73.4/2 = 36.7 when result was < 73.4.
    Time Frame Baseline and week 12

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at baseline and specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 37 40 33 30 28 28 35 36
    Mean (Standard Deviation) [picomole per milliliter (pmol/L)]
    1.49
    (7.41)
    -1.29
    (53.58)
    20.47
    (93.37)
    10.15
    (96.52)
    -4.85
    (56.56)
    -15.99
    (213.04)
    -32.08
    (198.54)
    1.32
    (5.68)
    36. Secondary Outcome
    Title Change Over Time From Baseline in Plasma Concentrations of Sex Hormone-Binding Globulin (SHBG) at Week 12
    Description Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.
    Time Frame Baseline and week 12

    Outcome Measure Data

    Analysis Population Description
    FAS population with available data at baseline and specified time point.
    Arm/Group Title Placebo Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    Measure Participants 37 40 33 30 28 28 35 36
    Mean (Standard Deviation) [Nanomole per liter (nmol/L)]
    1.877
    (12.270)
    0.720
    (14.220)
    4.867
    (10.492)
    1.621
    (16.329)
    6.643
    (11.107)
    2.350
    (17.852)
    0.143
    (8.741)
    0.583
    (14.283)

    Adverse Events

    Time Frame From date of informed consent until end of the study (up to 15 weeks)
    Adverse Event Reporting Description
    Arm/Group Title Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Arm/Group Description Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
    All Cause Mortality
    Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/45 (0%) 0/43 (0%) 0/45 (0%) 0/44 (0%) 0/43 (0%) 0/45 (0%) 0/44 (0%)
    Serious Adverse Events
    Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/45 (0%) 0/43 (0%) 0/45 (0%) 0/44 (0%) 0/43 (0%) 1/45 (2.2%) 0/44 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin 0/43 (0%) 0 0/45 (0%) 0 0/43 (0%) 0 0/45 (0%) 0 0/44 (0%) 0 0/43 (0%) 0 1/45 (2.2%) 1 0/44 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo BID Fezolinetant 15 mg BID Fezolinetant 30 mg BID Fezolinetant 60 mg BID Fezolinetant 90 mg BID Fezolinetant 30 mg QD Fezolinetant 60 mg QD Fezolinetant 120 mg QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/43 (11.6%) 9/45 (20%) 7/43 (16.3%) 11/45 (24.4%) 11/44 (25%) 12/43 (27.9%) 14/45 (31.1%) 11/44 (25%)
    Gastrointestinal disorders
    Diarrhoea 1/43 (2.3%) 1 0/45 (0%) 0 1/43 (2.3%) 1 2/45 (4.4%) 2 2/44 (4.5%) 2 1/43 (2.3%) 1 3/45 (6.7%) 3 0/44 (0%) 0
    Nausea 1/43 (2.3%) 1 1/45 (2.2%) 1 3/43 (7%) 3 3/45 (6.7%) 3 1/44 (2.3%) 1 2/43 (4.7%) 2 3/45 (6.7%) 3 2/44 (4.5%) 2
    General disorders
    Fatigue 0/43 (0%) 0 1/45 (2.2%) 1 1/43 (2.3%) 1 1/45 (2.2%) 1 2/44 (4.5%) 2 0/43 (0%) 0 3/45 (6.7%) 3 1/44 (2.3%) 1
    Infections and infestations
    Sinusitis 0/43 (0%) 0 0/45 (0%) 0 0/43 (0%) 0 3/45 (6.7%) 3 0/44 (0%) 0 1/43 (2.3%) 1 2/45 (4.4%) 2 0/44 (0%) 0
    Upper respiratory tract infection 1/43 (2.3%) 1 2/45 (4.4%) 2 1/43 (2.3%) 1 1/45 (2.2%) 1 1/44 (2.3%) 1 3/43 (7%) 3 1/45 (2.2%) 1 1/44 (2.3%) 1
    Urinary tract infection 1/43 (2.3%) 1 2/45 (4.4%) 2 1/43 (2.3%) 1 2/45 (4.4%) 2 2/44 (4.5%) 2 2/43 (4.7%) 2 2/45 (4.4%) 2 3/44 (6.8%) 4
    Viral upper respiratory tract infection 0/43 (0%) 0 2/45 (4.4%) 3 1/43 (2.3%) 2 1/45 (2.2%) 1 3/44 (6.8%) 3 0/43 (0%) 0 0/45 (0%) 0 0/44 (0%) 0
    Nervous system disorders
    Headache 2/43 (4.7%) 2 3/45 (6.7%) 3 2/43 (4.7%) 2 2/45 (4.4%) 2 1/44 (2.3%) 1 6/43 (14%) 6 3/45 (6.7%) 3 4/44 (9.1%) 4
    Respiratory, thoracic and mediastinal disorders
    Cough 0/43 (0%) 0 1/45 (2.2%) 1 0/43 (0%) 0 1/45 (2.2%) 1 0/44 (0%) 0 0/43 (0%) 0 3/45 (6.7%) 3 0/44 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.

    Results Point of Contact

    Name/Title Clinical Trial Disclosure
    Organization Astellas Pharma Global Development, Inc.
    Phone 800-888-7704
    Email astellas.resultsdisclosure@astellas.com
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT03192176
    Other Study ID Numbers:
    • ESN364_HF_205
    First Posted:
    Jun 19, 2017
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Aug 1, 2021