COXIBUS: A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT01572675
Collaborator
(none)
547
33

Study Details

Study Description

Brief Summary

This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
547 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Group Arcoxia®

Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.

Drug: etorocoxib
Administered as 30 mg or 60 mg oral film-coated tablets
Other Names:
  • Arcoxia®
  • Group Celebrex®

    Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.

    Drug: celecoxib
    Administered as 100 mg or 200 mg oral hard capsules
    Other Names:
  • Celebrex®
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex® [Up to 12 months]

      Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

    2. Reasons for Misuse of Arcoxia® and Celebrex® [Up to 12 months]

      Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

    3. Indications for Which Arcoxia® and Celebrex® Were Prescribed [At study entry]

      The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.

    4. Dosage of Arcoxia® and Celebrex® at Initiation [At study entry]

      Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.

    5. Mean Dosage of Arcoxia® and Celebrex® During Treatment [Up to 12 months]

      The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.

    6. Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex® [Up to 12 months]

      Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.

    7. Duration of Prescription for Arcoxia® and Celebrex® at Enrollment [Up to 3 months prior to study entry]

      The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.

    8. Total Duration of Treatment With Arcoxia® and Celebrex® [Up to 12 months]

      The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.

    9. Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex® [Up to 12 months]

      Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.

    10. Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex® [Up to 12 months]

      The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.

    11. Type of Arcoxia® and Celebrex® Use [Up to 12 months]

      The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.

    12. Type of Arcoxia® and Celebrex® Use According to Duration of Treatment [Up to 12 months]

      Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.

    Secondary Outcome Measures

    1. Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry (baseline)]

      Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.

    2. Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry (baseline)]

      Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.

    3. Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry (baseline)]

      Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.

    4. Medical History of Participants Treated With Arcoxia® and Celebrex® [At study entry]

      Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.

    5. Co-morbidities in Participants Treated With Arcoxia® and Celebrex® [At study entry]

      Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease

    6. Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex® [At study entry]

      'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.

    7. Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry]

      Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.

    8. Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex® [Up to 12 months]

      Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.

    9. Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex® [Up to 3 months prior to study entry]

      Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.

    10. Number of Participants Switching to Another Treatment With the Same Reason for Prescription [Up to 12 months]

      Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.

    11. Number of Participants With Contraindications for Use of Arcoxia® [At study entry]

      Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.

    12. Number of Participants Who Experienced at Least One Adverse Event [Up to 12 months]

      An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

    13. Number of Participants Who Discontinued Study Drug Due to an Adverse Event [Up to 12 months]

      Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Treatment-naive, discontinued the previous treatment course of etoricoxib or celecoxib at least 3 months previously or currently receiving continuous treatment with oral etoricoxib or celecoxib

    • Consent to take part in the study

    • Included in his/her physician's client base for at least 1 year

    Exclusion Criteria:
    • Unable to receive follow-up over a year

    • Included in an interventional trial

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01572675
    Other Study ID Numbers:
    • 0663-148
    First Posted:
    Apr 6, 2012
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Organon and Co
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 621 total participants were screened; 71 participants were excluded for inclusion criteria violation and 3 were excluded for unavailability of informed consent.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Period Title: Overall Study
    STARTED 268 279
    COMPLETED 31 56
    NOT COMPLETED 237 223

    Baseline Characteristics

    Arm/Group Title Group Arcoxia® Group Celebrex® Total
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Total of all reporting groups
    Overall Participants 268 279 547
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    60.8
    (13.8)
    62.4
    (14.2)
    61.6
    (14.0)
    Sex: Female, Male (Count of Participants)
    Female
    166
    61.9%
    179
    64.2%
    345
    63.1%
    Male
    102
    38.1%
    100
    35.8%
    202
    36.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®
    Description Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 257 264
    Number [Participants]
    65
    24.3%
    118
    42.3%
    2. Primary Outcome
    Title Reasons for Misuse of Arcoxia® and Celebrex®
    Description Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse)
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 192 146
    Non-MA-Compliant Indication
    83
    31%
    114
    40.9%
    Non-MA-Compliant Starting Dose
    62
    23.1%
    19
    6.8%
    Non-MA-Compliant Starting Dose and Indication
    46
    17.2%
    13
    4.7%
    Non-MA-Compliant Indication & Dose (Starting &Max)
    1
    0.4%
    0
    0%
    3. Primary Outcome
    Title Indications for Which Arcoxia® and Celebrex® Were Prescribed
    Description The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication)
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 264 275
    Other pain (e.g., spinal pain, joint pain)
    113
    42.2%
    117
    41.9%
    Osteoarthritis
    105
    39.2%
    104
    37.3%
    Inflammatory rheumatism
    13
    4.9%
    18
    6.5%
    Neuralgia
    17
    6.3%
    24
    8.6%
    Non-joint rheumatism
    12
    4.5%
    12
    4.3%
    Unclassified arthropathy
    4
    1.5%
    0
    0%
    Missing data
    4
    1.5%
    4
    1.4%
    4. Primary Outcome
    Title Dosage of Arcoxia® and Celebrex® at Initiation
    Description Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation)
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 268 279
    30 mg
    151
    56.3%
    0
    0%
    60 mg
    107
    39.9%
    0
    0%
    > 60 mg; <100 mg
    1
    0.4%
    0
    0%
    100 mg
    0
    0%
    23
    8.2%
    >100 mg; < 200 mg
    1
    0.4%
    0
    0%
    200 mg
    0
    0%
    219
    78.5%
    400 mg
    0
    0%
    32
    11.5%
    > 400 mg
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Mean Dosage of Arcoxia® and Celebrex® During Treatment
    Description The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 246 252
    Mean (Standard Deviation) [mg/day]
    44.1
    (14.8)
    221.9
    (73.1)
    6. Primary Outcome
    Title Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
    Description Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 246 252
    Missing data
    1
    0.4%
    5
    1.8%
    Dose increase
    42
    15.7%
    33
    11.8%
    Dose decrease followed by increase
    1
    0.4%
    0
    0%
    Dose decrease
    2
    0.7%
    5
    1.8%
    Dose increase followed by decrease
    0
    0%
    3
    1.1%
    7. Primary Outcome
    Title Duration of Prescription for Arcoxia® and Celebrex® at Enrollment
    Description The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.
    Time Frame Up to 3 months prior to study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 119 157 268 276
    Mean (Standard Deviation) [Days]
    25.5
    (18.4)
    38.1
    (24.1)
    23.9
    (17.6)
    41.7
    (26.9)
    31.1
    (22.0)
    34.0
    (24.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for duration of prescription at enrollment
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method p-student
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group Celebrex® - Initiation, Group Celebrex® - Renewal
    Comments Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for duration of prescription at enrollment
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method p-student
    Comments
    8. Primary Outcome
    Title Total Duration of Treatment With Arcoxia® and Celebrex®
    Description The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 251 256
    DoT - End-of-study participants (n=215,196)
    85.2
    (127.1)
    117.8
    (307.6)
    DoT - End-of-protocol participants (n=31,56)
    472.9
    (90.7)
    595.2
    (456.7)
    DoT - Lost to follow-up participants (n=5,4)
    122.4
    (131.6)
    142.0
    (128.8)
    9. Primary Outcome
    Title Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®
    Description Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 137 109 109 143 246 252
    Mean (Standard Deviation) [mg/day]
    47.1
    (16.2)
    48.4
    (14.7)
    228.4
    (79.5)
    242.7
    (86.0)
    47.7
    (15.5)
    236.5
    (83.4)
    10. Primary Outcome
    Title Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
    Description The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 215 196
    End of prescribed treatment
    140
    52.2%
    118
    42.3%
    Recovery
    16
    6%
    23
    8.2%
    Lack of efficacy
    31
    11.6%
    31
    11.1%
    Intolerance
    6
    2.2%
    5
    1.8%
    Improved symptoms
    8
    3%
    2
    0.7%
    Surgical intervention
    3
    1.1%
    6
    2.2%
    Participant decision
    5
    1.9%
    1
    0.4%
    Physician decision
    2
    0.7%
    2
    0.7%
    Death unrelated to coxibs
    1
    0.4%
    1
    0.4%
    Other disease detected
    1
    0.4%
    1
    0.4%
    Other - unknown reason
    1
    0.4%
    1
    0.4%
    Rheumatologist new evaluation
    0
    0%
    1
    0.4%
    Missing data
    1
    0.4%
    4
    1.4%
    11. Primary Outcome
    Title Type of Arcoxia® and Celebrex® Use
    Description The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 215 194
    Missing data
    0
    0%
    2
    0.7%
    Intermittent
    44
    16.4%
    47
    16.8%
    Continuous
    171
    63.8%
    147
    52.7%
    12. Primary Outcome
    Title Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
    Description Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Up to Thirty Days From One to Three Months From Three Months to One Year More Than One Year
    Arm/Group Description Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year
    Measure Participants 206 112 75 18
    Missing data
    0
    (127.1) 0%
    1
    (307.6) 0.4%
    1
    0.2%
    0
    NaN
    Intermittent
    24
    (90.7) 9%
    38
    (456.7) 13.6%
    22
    4%
    7
    NaN
    Continuous
    182
    (131.6) 67.9%
    73
    (128.8) 26.2%
    52
    9.5%
    11
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex® - Renewal
    Comments Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared
    Comments
    13. Secondary Outcome
    Title Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
    Description Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.
    Time Frame At study entry (baseline)

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 147 119 120 158 266 278
    Mean (Standard Deviation) [kg/m^2]
    26.6
    (5.2)
    27.1
    (4.5)
    27.3
    (4.5)
    27.0
    (5.6)
    26.8
    (4.9)
    27.1
    (5.1)
    14. Secondary Outcome
    Title Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
    Description Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
    Time Frame At study entry (baseline)

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 146 118 116 158 264 274
    SBP
    127.4
    (10.7)
    130.9
    (9.9)
    127.9
    (9.5)
    128.4
    (8.2)
    129.0
    (10.4)
    128.2
    (8.8)
    DBP
    76.0
    (7.0)
    76.8
    (7.3)
    76.0
    (7.6)
    75.1
    (7.1)
    76.4
    (7.1)
    75.4
    (7.3)
    15. Secondary Outcome
    Title Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
    Description Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
    Time Frame At study entry (baseline)

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 121 158 268 279
    MIssing data
    3
    (10.7) 1.1%
    1
    (9.9) 0.4%
    5
    (9.5) 0.9%
    0
    (8.2) NaN
    4
    (10.4) NaN
    5
    (8.8) NaN
    <120/80 mmHg
    15
    (7.0) 5.6%
    5
    (7.3) 1.8%
    8
    (7.6) 1.5%
    6
    (7.1) NaN
    20
    (7.1) NaN
    14
    (7.3) NaN
    120 mmHg ≤SBP<140 mmHg and/or 80 mmHg ≤DBP<90 mmHg
    105
    39.2%
    80
    28.7%
    87
    15.9%
    127
    NaN
    185
    NaN
    214
    NaN
    140 mmHg ≤SBP<180 mmHg and/or 90 mmHg≤DBP<100 mmHg
    26
    9.7%
    33
    11.8%
    21
    3.8%
    25
    NaN
    59
    NaN
    46
    NaN
    SBP≥180 mmHg and/or DBP≥110 mmHg
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.104
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group Celebrex® - Initiation, Group Celebrex® - Renewal
    Comments Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.618
    Comments
    Method Chi-squared
    Comments
    16. Secondary Outcome
    Title Medical History of Participants Treated With Arcoxia® and Celebrex®
    Description Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 121 158 268 279
    Arterial hypertension (n=146,118,116,156,264,272)
    37
    13.8%
    47
    16.8%
    34
    6.2%
    58
    NaN
    84
    NaN
    92
    NaN
    Acute rhinitis (n=145,115,115,157,260,272)
    20
    7.5%
    15
    5.4%
    10
    1.8%
    12
    NaN
    35
    NaN
    22
    NaN
    Bronchospam (n=145,117,115,158,262,273)
    9
    3.4%
    6
    2.2%
    2
    0.4%
    6
    NaN
    15
    NaN
    8
    NaN
    Urticaria (n=146,116,115,156,262,271)
    5
    1.9%
    5
    1.8%
    0
    0%
    4
    NaN
    10
    NaN
    4
    NaN
    Peptic ulcer/bleeding (n=146,118,117,158,264,275)
    5
    1.9%
    0
    0%
    3
    0.5%
    4
    NaN
    5
    NaN
    7
    NaN
    Angioedema (n=145,117,114,157,262,271)
    2
    0.7%
    0
    0%
    1
    0.2%
    2
    NaN
    2
    NaN
    3
    NaN
    Nasal polyps (n=146,116,114,158,262,272)
    0
    0%
    1
    0.4%
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for medical history of arterial hypertension
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group Celebrex® - Initiation, Group Celebrex® - Renewal
    Comments Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for medical history of arterial hypertension
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.175
    Comments
    Method Chi-squared
    Comments
    17. Secondary Outcome
    Title Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
    Description Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 121 158 268 279
    At least one co-morbidity
    55
    20.5%
    44
    15.8%
    32
    5.9%
    62
    NaN
    99
    NaN
    94
    NaN
    Hyperlipidemia
    43
    16%
    34
    12.2%
    26
    4.8%
    46
    NaN
    77
    NaN
    72
    NaN
    Diabetes
    14
    5.2%
    11
    3.9%
    6
    1.1%
    22
    NaN
    25
    NaN
    28
    NaN
    Hepatic insufficiency
    4
    1.5%
    3
    1.1%
    0
    0%
    2
    NaN
    7
    NaN
    2
    NaN
    Inflammatory bowel disease
    2
    0.7%
    4
    1.4%
    3
    0.5%
    1
    NaN
    6
    NaN
    4
    NaN
    CHF/IHD/PAD
    1
    0.4%
    2
    0.7%
    3
    0.5%
    6
    NaN
    3
    NaN
    9
    NaN
    Active peptic ulceration/ GI bleeding
    1
    0.4%
    0
    0%
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    Missing data
    5
    1.9%
    2
    0.7%
    4
    0.7%
    0
    NaN
    7
    NaN
    4
    NaN
    18. Secondary Outcome
    Title Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
    Description 'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 121 158 268 279
    At least one treatment (n=146,118,117,158,264,275)
    102
    38.1%
    75
    26.9%
    67
    12.2%
    118
    NaN
    177
    NaN
    185
    NaN
    Proton-pump inhibitors (n=146,115,116,156,261,272)
    58
    21.6%
    43
    15.4%
    30
    5.5%
    65
    NaN
    101
    NaN
    95
    NaN
    Hypolipidemic agents (n=146,116,117,156,262,273)
    39
    14.6%
    32
    11.5%
    24
    4.4%
    45
    NaN
    71
    NaN
    69
    NaN
    ARBs (n=144,115,116,155,259,271)
    22
    8.2%
    29
    10.4%
    23
    4.2%
    37
    NaN
    51
    NaN
    60
    NaN
    Diuretics (N=146,117,117,156,263,273)
    16
    6%
    24
    8.6%
    10
    1.8%
    29
    NaN
    40
    NaN
    39
    NaN
    ACEIs (n=145,116,117,157,261,274)
    11
    4.1%
    22
    7.9%
    13
    2.4%
    20
    NaN
    33
    NaN
    33
    NaN
    SSRIs (n=146,116,117,158,262,275)
    15
    5.6%
    15
    5.4%
    8
    1.5%
    25
    NaN
    30
    NaN
    33
    NaN
    Anti-diabetic agents (n=146,115,117,158,261,275)
    14
    5.2%
    8
    2.9%
    6
    1.1%
    19
    NaN
    22
    NaN
    25
    NaN
    Histamine H2 blockers (n=146,117,117,156,263,273)
    14
    5.2%
    14
    5%
    7
    1.3%
    20
    NaN
    28
    NaN
    27
    NaN
    PAIs (n=146,118,117,158,264,275)
    5
    1.9%
    8
    2.9%
    6
    1.1%
    8
    NaN
    13
    NaN
    14
    NaN
    Oral anticoagulants (n=146,118,117,158,264,275)
    1
    0.4%
    4
    1.4%
    3
    0.5%
    6
    NaN
    5
    NaN
    9
    NaN
    Alpha-blockers (n=146,116,117,157,262,274)
    1
    0.4%
    1
    0.4%
    4
    0.7%
    5
    NaN
    2
    NaN
    9
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for significant past treatments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.701
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group Celebrex® - Initiation, Group Celebrex® - Renewal
    Comments Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for significant past treatments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparison (Arcoxia® vs Celebrex®) for significant past treatments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.955
    Comments
    Method Chi-squared
    Comments
    19. Secondary Outcome
    Title Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
    Description Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 121 158 268 279
    Missing data
    15
    5.6%
    22
    7.9%
    3
    0.5%
    23
    NaN
    37
    NaN
    26
    NaN
    At least one treatment
    95
    35.4%
    89
    31.9%
    73
    13.3%
    120
    NaN
    184
    NaN
    193
    NaN
    Analgesics
    52
    19.4%
    66
    23.7%
    38
    6.9%
    75
    NaN
    118
    NaN
    113
    NaN
    Cardiovascular agents
    30
    11.2%
    40
    14.3%
    31
    5.7%
    59
    NaN
    70
    NaN
    90
    NaN
    Digestive system agents
    37
    13.8%
    33
    11.8%
    22
    4%
    61
    NaN
    70
    NaN
    83
    NaN
    Nervous system agents
    17
    6.3%
    24
    8.6%
    14
    2.6%
    45
    NaN
    41
    NaN
    59
    NaN
    NSAIDS
    25
    9.3%
    21
    7.5%
    15
    2.7%
    28
    NaN
    46
    NaN
    43
    NaN
    Rheumatologic agents
    17
    6.3%
    21
    7.5%
    23
    4.2%
    29
    NaN
    38
    NaN
    52
    NaN
    Metabolic system agents
    14
    5.2%
    23
    8.2%
    11
    2%
    38
    NaN
    37
    NaN
    49
    NaN
    Respiratory system agents
    9
    3.4%
    16
    5.7%
    7
    1.3%
    21
    NaN
    25
    NaN
    28
    NaN
    Hormonal agents
    8
    3%
    13
    4.7%
    6
    1.1%
    15
    NaN
    21
    NaN
    21
    NaN
    Hematologic agents
    1
    0.4%
    10
    3.6%
    6
    1.1%
    16
    NaN
    11
    NaN
    22
    NaN
    Urinary-genital system agents
    4
    1.5%
    4
    1.4%
    6
    1.1%
    12
    NaN
    8
    NaN
    18
    NaN
    Dermatological agents
    7
    2.6%
    1
    0.4%
    4
    0.7%
    14
    NaN
    8
    NaN
    18
    NaN
    Anti-infectious agents
    4
    1.5%
    4
    1.4%
    2
    0.4%
    12
    NaN
    8
    NaN
    14
    NaN
    Other not-classified
    6
    2.2%
    5
    1.8%
    5
    0.9%
    23
    NaN
    11
    NaN
    28
    NaN
    20. Secondary Outcome
    Title Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
    Description Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 104 116
    Missing data
    26
    9.7%
    38
    13.6%
    At least one treatment
    75
    28%
    65
    23.3%
    Analgesics
    58
    21.6%
    55
    19.7%
    Cardiovascular agents
    41
    15.3%
    39
    14%
    Digestive system agents
    39
    14.6%
    36
    12.9%
    Nervous system agents
    25
    9.3%
    32
    11.5%
    Respiratory system agents
    32
    11.9%
    23
    8.2%
    Metabolic system agents
    28
    10.4%
    22
    7.9%
    Rheumatologic agents
    19
    7.1%
    20
    7.2%
    NSAIDS
    17
    6.3%
    21
    7.5%
    Anti-infectious agents
    16
    6%
    16
    5.7%
    Hormonal agents
    12
    4.5%
    13
    4.7%
    Dermatological agents
    13
    4.9%
    12
    4.3%
    Hematologic agents
    14
    5.2%
    8
    2.9%
    Urinary-genital system agents
    8
    3%
    8
    2.9%
    Other
    17
    6.3%
    17
    6.1%
    21. Secondary Outcome
    Title Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
    Description Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.
    Time Frame Up to 3 months prior to study entry

    Outcome Measure Data

    Analysis Population Description
    The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Celebrex® - Initiation Group Celebrex® - Renewal Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 121 158 268 279
    At least one treatment (n=146,118,117,158,264,275)
    93
    34.7%
    86
    30.8%
    62
    11.3%
    102
    NaN
    179
    NaN
    164
    NaN
    Paracetamol (n=146,118,117,158,264,275)
    83
    31%
    82
    29.4%
    54
    9.9%
    90
    NaN
    165
    NaN
    144
    NaN
    NSAIDS (n=146,118,117,158,264,275)
    33
    12.3%
    19
    6.8%
    19
    3.5%
    23
    NaN
    52
    NaN
    42
    NaN
    Analgesics (n=146,118,117,158,264,275)
    4
    1.5%
    4
    1.4%
    1
    0.2%
    7
    NaN
    8
    NaN
    8
    NaN
    Corticosteroids (n=140,107,111,152,247,263)
    7
    2.6%
    3
    1.1%
    6
    1.1%
    13
    NaN
    10
    NaN
    19
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.049
    Comments
    Method Fisher Exact
    Comments
    22. Secondary Outcome
    Title Number of Participants Switching to Another Treatment With the Same Reason for Prescription
    Description Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 215 196
    Prescription of a new treatment
    33
    12.3%
    29
    10.4%
    NSAIDS
    22
    8.2%
    22
    7.9%
    Analgesics
    9
    3.4%
    6
    2.2%
    Other (TNF-alpha inhibitors, corticosteroids)
    1
    0.4%
    1
    0.4%
    23. Secondary Outcome
    Title Number of Participants With Contraindications for Use of Arcoxia®
    Description Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.
    Time Frame At study entry

    Outcome Measure Data

    Analysis Population Description
    The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications)
    Arm/Group Title Group Arcoxia® - Initiation Group Arcoxia® - Renewal Group Arcoxia®
    Arm/Group Description Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 149 119 268
    At least one contraindication (n=122,100,122)
    36
    13.4%
    34
    12.2%
    70
    12.8%
    One total contraindication (n=36,34,70)
    29
    10.8%
    32
    11.5%
    61
    11.2%
    Two total contraindications (n=36,34,70)
    7
    2.6%
    2
    0.7%
    9
    1.6%
    History of acute rhinitis (n=145,115,260)
    20
    7.5%
    15
    5.4%
    35
    6.4%
    Creatinine clearance <30 ml/min (n=125,108,233)
    1
    0.4%
    0
    0%
    1
    0.2%
    History of bronchospasm (n=145,117,262)
    9
    3.4%
    6
    2.2%
    15
    2.7%
    History of urticaria (n=146,116,262)
    5
    1.9%
    5
    1.8%
    10
    1.8%
    Presence of IBD (n=146,118,264)
    2
    0.7%
    4
    1.4%
    6
    1.1%
    Presence of CHF (n=146,118,264)
    0
    0%
    2
    0.7%
    2
    0.4%
    Presence of IHD and/or PAD (n=142,118,260)
    1
    0.4%
    2
    0.7%
    3
    0.5%
    History of allergic reaction (n=145,118,263)
    1
    0.4%
    0
    0%
    1
    0.2%
    History of nasal polyps (n=146,116,262)
    0
    0%
    1
    0.4%
    1
    0.2%
    Blood pressure not controlled (n=146,118,264)
    1
    0.4%
    0
    0%
    1
    0.2%
    History of angioedema (n=145,117,262)
    2
    0.7%
    0
    0%
    2
    0.4%
    Patients with severe HA (n=146,118,264)
    1
    0.4%
    0
    0%
    1
    0.2%
    <16 years of age (n=149,119,268)
    0
    0%
    0
    0%
    0
    0%
    Pregnancy or lactation (n=92,73,165)
    0
    0%
    1
    0.4%
    1
    0.2%
    24. Secondary Outcome
    Title Number of Participants Who Experienced at Least One Adverse Event
    Description An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The safety population consisting of all participants who enrolled in the study
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 268 279
    Number [Participants]
    10
    3.7%
    5
    1.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group Arcoxia®, Group Celebrex®
    Comments Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.165
    Comments
    Method Chi-squared
    Comments
    25. Secondary Outcome
    Title Number of Participants Who Discontinued Study Drug Due to an Adverse Event
    Description Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The safety population consisting of all participants who enrolled in the study
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    Measure Participants 268 279
    Number [Participants]
    6
    2.2%
    5
    1.8%

    Adverse Events

    Time Frame Up to 12 months
    Adverse Event Reporting Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All participants who enrolled in the study were included in the safety reporting.
    Arm/Group Title Group Arcoxia® Group Celebrex®
    Arm/Group Description Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
    All Cause Mortality
    Group Arcoxia® Group Celebrex®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Group Arcoxia® Group Celebrex®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/268 (0%) 0/279 (0%)
    Other (Not Including Serious) Adverse Events
    Group Arcoxia® Group Celebrex®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/268 (0%) 0/279 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01572675
    Other Study ID Numbers:
    • 0663-148
    First Posted:
    Apr 6, 2012
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022