SYNERGY: This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

Sponsor

Astellas Pharma Europe B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT01972841

Collaborator

(none)

3,527

Enrollment

435

Locations

Arms

23.5

Actual Duration (Months)

8.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Overactive Urinary Bladder Diseases\Urologic Diseases Overactive Bladder Urgency Incontinence	Drug: Solifenacin succinate Drug: Mirabegron Drug: Placebo to match solifenacin succinate Drug: Placebo to match mirabegron	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

3527 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Actual Study Start Date :

Nov 5, 2013

Actual Primary Completion Date :

Oct 22, 2015

Actual Study Completion Date :

Oct 22, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1: Solifenacin 5 mg + Mirabegron 25 mg Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Drug: Solifenacin succinate Oral tablet Other Names: Vesikur Vesitrim YM905 Vesicare Drug: Mirabegron Oral tablet Other Names: YM178 Betmiga Betanis Myrbetriq Drug: Placebo to match mirabegron Oral tablet
Experimental: 2: Solifenacin 5 mg + Mirabegron 50 mg Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.	Drug: Solifenacin succinate Oral tablet Other Names: Vesikur Vesitrim YM905 Vesicare Drug: Mirabegron Oral tablet Other Names: YM178 Betmiga Betanis Myrbetriq Drug: Placebo to match mirabegron Oral tablet
Placebo Comparator: 3: Placebo Participants who received matching placebo once a day for 12 weeks.	Drug: Placebo to match solifenacin succinate Oral tablet Drug: Placebo to match mirabegron Oral tablet
Active Comparator: 4: Solifenacin 5 mg Participants who received solifenacin 5 mg once a day for 12 weeks.	Drug: Solifenacin succinate Oral tablet Other Names: Vesikur Vesitrim YM905 Vesicare Drug: Placebo to match mirabegron Oral tablet
Active Comparator: 5:Mirabegron 25 mg Participants who received mirabegron 25 mg once a day for 12 weeks.	Drug: Mirabegron Oral tablet Other Names: YM178 Betmiga Betanis Myrbetriq Drug: Placebo to match solifenacin succinate Oral tablet Drug: Placebo to match mirabegron Oral tablet
Active Comparator: 6: Mirabegron 50 mg Participants who received mirabegron 50 mg once a day for 12 weeks.	Drug: Mirabegron Oral tablet Other Names: YM178 Betmiga Betanis Myrbetriq Drug: Placebo to match solifenacin succinate Oral tablet Drug: Placebo to match mirabegron Oral tablet

Outcome Measures

Primary Outcome Measures

Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours [Baseline and EoT (up to 12 weeks)]
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours [Baseline and EoT (up to 12 weeks)]
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

Secondary Outcome Measures

Change From Baseline to EoT in Mean Volume Voided Per Micturition [Baseline and EoT (up to 12 weeks)]
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [Baseline and EoT (up to 12 weeks)]
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) [Baseline and EoT (up to 12 weeks)]
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours [Baseline and weeks 4, 8 and 12]
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours [Baseline and weeks 4, 8 and 12]
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition [Baseline and weeks 4, 8 and 12]
Change From Baseline to EoT in Corrected Micturition Frequency [Baseline and Week 12]
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes [Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Pads Used at Weeks 4, 8, 12 and EoT [Weeks 4, 8 and 12 (up to 12 weeks)]
The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used [Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours [Baseline and weeks 4, 8 and 12 (up to 12 weeks)]
The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT [Weeks 4, 8,12 and EoT (up to 12 weeks)]
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC) [Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)]
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score [Baseline and weeks 4, 8 and 12]
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT [Week 12 and EoT (up to 12 weeks)]
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
PGIC Scale: Impression in General Health at Week 12 and EoT [Week 12 and EoT (up to 12 weeks)]
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility [Baseline and EoT (up to 12 weeks)]
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care [Baseline and EoT (up to 12 weeks)]
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities [Baseline and EoT (up to 12 weeks)]
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort [Baseline and EoT (up to 12 weeks)]
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression [Baseline and EoT (up to 12 weeks)]
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed [Baseline and week 12 and EoT (up to 12 weeks)]
The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working [Baseline and week 12 and EoT (up to 12 weeks)]
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment [Baseline and week 12 and EoT (up to 12 weeks)]
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment [Baseline and week 12 and EoT (up to 12 weeks)]
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS [Baseline and week 4, 8 and 12]
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT [Weeks 4, 8 , 12 and EoT (up to 12 weeks)]
The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT [Weeks 4, 8, 12 and EoT (up to 12 weeks)]
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)]
A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume [Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)]
PVR volume was assessed by ultrasonography or a bladder scanner.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR) [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference [Baseline and weeks 4, 12 and EoT (up to 12 weeks)]
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria:

Subject had significant PVR volume (> 150 mL);
Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
Subject had an indwelling catheter or practices intermittent self catheterization.
Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
Subject had moderate to severe hepatic impairment
Subject had severe renal impairment
Subject had a clinically significant abnormal ECG
Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site US10049 Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	Site US10112 TFI, LLC	Mobile	Alabama	United States	36608
3	Site US10104 Clinical Research Advantage, Inc.	Chandler	Arizona	United States	85224
4	Site US10021 Beach Clinical Studies	Phoenix	Arizona	United States	85051
5	Site US10122 Orange County Research Institute	Anaheim	California	United States	92801
6	Site US10098 Skyline Research	Cerritos	California	United States	90703
7	Site US10539 Citrus Valley Medical Research	Glendora	California	United States	91741
8	Site US10082 American Clinical Trials	Hawaiian Gardens	California	United States	90716
9	Site US10132 Axis Clinical Trials	Los Angeles	California	United States	90017
10	Site US10133 Axis Clinical Trials	Los Angeles	California	United States	90036
11	Site US10536 Stanford School of Medicine	Palo Alto	California	United States	93404
12	Site US10149 Bayview Research Group	Paramount	California	United States	90723
13	Site US10559 UC Davis Medical Center	Sacramento	California	United States	95817
14	Site US10003 San Diego Clinical Trials	San Diego	California	United States	92120
15	Site US10545 San Diego Institute for Sexual Medicine	San Diego	California	United States	92120
16	Site US10106 West Coast Clinical Research	Tarzana	California	United States	91356
17	Site US10595 Bayview Research Group	Valley Village	California	United States	91607
18	Site US10034 Urology Center of Colorado	Denver	Colorado	United States	80211
19	Site US10070 Physicians' Research Options/Red Rocks OB/GYN	Lakewood	Colorado	United States	80228
20	Site US10053 Western Clinical Research, Inc.	Wheat Ridge	Colorado	United States	80033
21	Site US10128 Clinical Research Center of CT	Danbury	Connecticut	United States	06810
22	Site US10018 Grove Hill Clinical Research	New Britain	Connecticut	United States	06052
23	Site US10170 Yale - New Haven Hospital West Haven VAMC	New Haven	Connecticut	United States	06510
24	Site US10123 Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
25	Site US10060 Meridien Research	Bradenton	Florida	United States	34208
26	Site US10097 A.G.A. Clinical Trials DBA Neostart Group	Hialeah	Florida	United States	33012
27	Site US10148 Best Quality Research, Inc.	Hialeah	Florida	United States	33016
28	Site US10153 Palmetto Professional Research	Hialeah	Florida	United States	33016
29	Site US10159 Urological Research Network	Hialeah	Florida	United States	33016
30	Site US10534 South Florida Medical Research	Hialeah	Florida	United States	33016
31	Site US10535 South Florida Medical Research	Homestead	Florida	United States	33030
32	Site US10165 East Coast Institute for Research	Jacksonville	Florida	United States	32216
33	Site US10091 Health Awareness	Jupiter	Florida	United States	33458
34	Site US10150 Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
35	Site US10158 Renstar Medical Research	Ocala	Florida	United States	34471
36	Site US10124 Winter Park Urology Associates	Orlando	Florida	United States	32803
37	Site US10134 Compass Research, LLC	Orlando	Florida	United States	32806
38	Site US10009 South Broward Research	Pembroke Pines	Florida	United States	33027
39	Site US10540 Demaur Clinical Research, INC	Pembroke Pines	Florida	United States	33028
40	Site US10554 Private Practice	Plantation	Florida	United States	33317
41	Site US10095 Florida Urology Specialists	Sarasota	Florida	United States	34237
42	Site US10010 Southeastern Research Group, Inc	Tallahassee	Florida	United States	32308
43	Site US10014 Private Practice	Wellington	Florida	United States	33449
44	Site US10037 Atlanta Medical Research Institute	Alpharetta	Georgia	United States	30005
45	Site US10127 Perimeter North Medical Research, Inc.	Roswell	Georgia	United States	30076
46	Site US10120 WR-Mount Vernon Clinical Research	Sandy Springs	Georgia	United States	30328
47	Site US10024 GTC Research	Shawnee Mission	Kansas	United States	66218
48	Site US10078 Heartland Research Associates, LLC	Wichita	Kansas	United States	67205
49	Site US10088 Centex Studies, Inc.	Lake Charles	Louisiana	United States	70601
50	Site US10074 Medpharmics, LLC	Metairie	Louisiana	United States	70006
51	Site US10025 Regional Urology, LLC	Shreveport	Louisiana	United States	71106
52	Site US10558 Chesapeake Urology Research Associates	Glen Burnie	Maryland	United States	21061
53	Site US10560 Chesapeake Urology Research Associates	Owings Mills	Maryland	United States	21117
54	Site US10282 Boston Clinical Trials	Boston	Massachusetts	United States	02131
55	Site US10114 Bay State Clinical Trials, Inc.	Watertown	Massachusetts	United States	02472
56	Site US10152 Female Pelvic Medicine & Urogynecology Institute	Grand Rapids	Michigan	United States	49503
57	Site US10542 Adult & Pediatric Urology Group	Sartell	Minnesota	United States	56377
58	Site US10110 Montana Health Research Institute, Inc.	Billings	Montana	United States	59102
59	Site US10154 Montana Medical Research Inc	Missoula	Montana	United States	59801
60	Site US10553 Women's Clinic of Lincoln	Lincoln	Nebraska	United States	68510
61	Site US10140 IVCTLV	Las Vegas	Nevada	United States	89106
62	Site US10002 Urology Center Research Institute	Englewood	New Jersey	United States	07631
63	Site US10051 AdvancedMed Research	Lawrenceville	New Jersey	United States	08648
64	Site US10047 Lawrence OBGYN Associates	Lawrenceville	New Jersey	United States	86480
65	Site US10162 Phoenix OB-GYN Associates, LLC	Moorestown	New Jersey	United States	08057
66	Site US10011 Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico	United States	87102
67	Site US10015 Urology Group of New Mexico	Albuquerque	New Mexico	United States	87109
68	Site US10077 Northeast Urogynecology	Albany	New York	United States	12205
69	Site US10089 Maimonides Medical Center	Brooklyn	New York	United States	11220
70	Site US10026 AccuMed Research Associates	Garden City	New York	United States	11530
71	Site US10040 Premier Medical Group Of The Hudson Valley	Kingston	New York	United States	12401
72	Site US10073 Manhattan Medical Research Practice, PLLC	New York	New York	United States	10016
73	Site US10249 New York Clinical Trials	New York	New York	United States	10018
74	Site US10168 Weill Cornell Medical College	New York	New York	United States	10065
75	Site US10126 Premier Medical Group	Newburgh	New York	United States	12550
76	Site US10028 Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
77	Site US10593 Upstate Clinical Research Associates LLC	Williamsville	New York	United States	14221
78	Site US10076 Carolina Clinical Trials	Concord	North Carolina	United States	28025
79	Site US10129 PMG Research of Raleigh	Raleigh	North Carolina	United States	27609
80	Site US10549 Associated Urologists of North Carolina	Raleigh	North Carolina	United States	27612
81	Site US10062 Piedmont Medical Research	Winston-Salem	North Carolina	United States	27103
82	Site US10050 Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
83	Site US10033 Ohio Clinical Research	Lyndhurst	Ohio	United States	44124
84	Site US10067 Family Practice Center of Wadsworth	Wadsworth	Ohio	United States	44281
85	Site US10551 The Christ Hospital	West Chester	Ohio	United States	45069
86	Site US10109 Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
87	Site US10541 Sunstone Medical Research	Medford	Oregon	United States	97504
88	Site US10008 Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania	United States	19004
89	Site US10045 Lancaster Urology	Lancaster	Pennsylvania	United States	17604
90	Site US10017 Philadelphia Clinical Research, LLC	Philadelphia	Pennsylvania	United States	19114
91	Site US10167 University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
92	Site US10250 Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania	United States	15236
93	Site US10248 Preferred Primary Care Physicians, Inc	Pittsburgh	Pennsylvania	United States	15243
94	Site US10063 Preferred Primary Care Physician Research	Uniontown	Pennsylvania	United States	15401
95	Site US10012 Advanced Clinical Concepts	West Reading	Pennsylvania	United States	19611
96	Site US10166 Medical University of South Carolina	Charleston	South Carolina	United States	29425
97	Site US10094 University Medical Group	Greer	South Carolina	United States	29650
98	Site US10046 Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
99	Site US10079 PMG Research of Charleston, LLC	Mount Pleasant	South Carolina	United States	29464
100	Site US10117 Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
101	Site US10023 Hillcrest Clinical Research, LLC	Simpsonville	South Carolina	United States	29681
102	Site US10101 Palmetto Clinical Research	Summerville	South Carolina	United States	29485
103	Site US10006 Holston Medical Group	Kingsport	Tennessee	United States	37660
104	Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc	Austin	Texas	United States	78745
105	Site US10066 Texas Urology PA	Carrollton	Texas	United States	75010
106	Site US10065 Advanced Research Associates	Corpus Christi	Texas	United States	78414
107	Site US10085 Centex Studies, Inc.	Houston	Texas	United States	77062
108	Site US10108 Clinical Trial Network	Houston	Texas	United States	77074
109	Site US10219 Methodist Urology Associates	Houston	Texas	United States	77094
110	Site US10093 Pioneer Research Solutions, Inc.	Houston	Texas	United States	77098
111	Site US10090 Protenium Clinical Research, LLC	Hurst	Texas	United States	76054
112	Site US10105 Clinical Trials of Texas	San Antonio	Texas	United States	78229
113	Site US10111 Clinical Trials of Texas	San Antonio	Texas	United States	78229
114	Site US10092 Physicians' Research Options/Salt Lake Women's Center	Sandy	Utah	United States	84070
115	Site US10032 National Clinical Research Inc.	Richmond	Virginia	United States	23294
116	Site US10064 The Group for Women	Virginia Beach	Virginia	United States	23456
117	Site US10083 Urology of Virginia, PLLC.	Virginia Beach	Virginia	United States	23462
118	Site US10013 Seattle Urology Research Center	Burien	Washington	United States	98166
119	Site US10004 Integrity Medical Research, LLC	Mountlake Terrace	Washington	United States	98043
120	Site US10155 Seattle Women's Health, Research, Gynecology	Seattle	Washington	United States	98105
121	Site US10135 Walla Walla Clinic	Walla Walla	Washington	United States	99362
122	Site AR54005 IUBA - Instituto Urologico de Buenos Aires	Buenos Aires		Argentina	1419
123	Site AR54003 Hospital Italiano de Buenos Aires	Buenos Aires		Argentina	C1181ACH
124	Site AR54006 Hospital Italiano de Buenos Aires	Buenos Aires		Argentina	C1181ACH
125	Site AR54001 CDU - Centro de Urología	Ciudad Autónoma Buenos Aires		Argentina	C1120AAT
126	Site AR54004 Instituto de Investigaciones Clnicas Rosario	Rosario Provincia De Santa Fe		Argentina	2000
127	Site AU61026 Ballarat Urology	Ballarat		Australia	3350
128	Site AU61022 Brisbane South Clinical Research Centre	Brisbane		Australia	4152
129	Site AU61005 Hunter Clinical Research	Broadmeadow		Australia	2292
130	Site AU61015 Repatriation General Hospital	Daw Park		Australia	5041
131	Site AU61025 Western Health	Footscray		Australia	3011
132	Site AU61012 Cabrini Hospital	Malvern		Australia	3144
133	Site AU61010 Nambour General Hospital	Nambour		Australia	4560
134	Site AU61002 The Royal Womens Hospital	Parkville		Australia	3052
135	Site AU61004 Keogh Institute for Medical Research	Perth		Australia	6009
136	Site AU61007 Prince of Wales Hospital	Randwick		Australia	2031
137	Site AU61008 Epworth Healthcare	Richmond		Australia	3121
138	Site AU61019 AusTrialsSherwood	Sherwood		Australia	4075
139	Site AU61017 Healthpac Medical Centre	Sydney		Australia	2000
140	Site AU61021 Royal Hospital for Women	Sydney		Australia	2031
141	Site AU61011 Illawarra Health and Medical Research Institute	Wollongong		Australia	2522
142	Site BE32004 Gent University Hospital	Gent		Belgium	9000
143	Site BE32011 Universitaire Ziekenhuizen Leuven	Leuven		Belgium	3000
144	Site BE32014 Hart Ziekenhuis	Roeselare		Belgium	8800
145	Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna	Sint-Truiden		Belgium	3800
146	Site BG35904 University Hospital (UMHAT) - George Stranski	Pleven		Bulgaria	5800
147	Site BG35908 MHAT Plovdiv AD	Plovdiv		Bulgaria	4003
148	Site BG35902 MHAT Ruse	Ruse		Bulgaria	7002
149	Site BG35905 MHAT Alexandrovska Hospital	Sofia		Bulgaria	1431
150	Site BG35903 MHATEM Pirogov	Sofia		Bulgaria	1606
151	Site BG35906 UMHAT Varna	Varna		Bulgaria	9000
152	Site BG35910 MHAT	Veliko Tarnovo		Bulgaria	5000
153	Site CA15029 Royal Alexandra Hospital	Edmonton	Alberta	Canada	T5H 3V9
154	Site CA15035 Glenrose Rehabilitation Hospital	Edmonton	Alberta	Canada	T6G 2P4
155	Site CA15033 Prohealth	Vancouver	British Columbia	Canada	V5Z 4E1
156	Site CA15008 Private Practice	Saint John	New Brunswick	Canada	E2L 3J8
157	Site CA15001 The Male/Female Health & Research Centre	Barrie	Ontario	Canada	L4M 7G1
158	Site CA15006 Bramalea Medical Centre	Brampton	Ontario	Canada	L6T 4S5
159	Site CA15003 Brantford Urology Research	Brantford	Ontario	Canada	N3R 4N3
160	Site CA15042 G. Kenneth Jansz Medicine Professional Corporation	Burlington	Ontario	Canada	L7N 3V2
161	Site CA15044 McMaster Institute of Urology	Hamilton	Ontario	Canada	L8N 4A6
162	Site CA15031 Centre for Applied Urology Research (CAUR)	Kingston	Ontario	Canada	K7L 3J7
163	Site CA15007 Eunoia2 Incorporated	Kitchener	Ontario	Canada	N2N 2B9
164	Site CA15034 Oxford/Richmond Medical	London	Ontario	Canada	N6A 5R9
165	Site CA15032 Stanley Flax Medical Prof Corp	North York	Ontario	Canada	M2J 1V1
166	Site CA15013 Sunnybrook Health Sciences Center	Toronto	Ontario	Canada	M4N 3M5
167	Site CA15004 Primehealth Clinical Research	Toronto	Ontario	Canada	M4S 1Y2
168	Site CA15002 Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
169	Site CA15026 Rhodin Recherche Clinique	Drummondville	Quebec	Canada	J2B 7T1
170	Site CA15015 Recherches Cliniques Theradev, Inc.	Granby	Quebec	Canada
171	Site CA15021 Urology South Shore Research	Greenfield Park	Quebec	Canada	J4V 2H3
172	Site CA15030 UroLaval	Laval	Quebec	Canada	H7G 2E6
173	Site CA15040 RechercheGCP Research	Montreal	Quebec	Canada	H2R1V6
174	Site CA15020 Diex Research Montreal	Montreal	Quebec	Canada	H4N 3C5
175	Site CA15010 Ultra Med Research, Inc.	Point-Claire	Quebec	Canada	H9R 4S3
176	Site CA15027 Diex Research Sherbrooke Inc	Sherbrooke	Quebec	Canada	J1H 1Z1
177	Site CA15039 Pro-recherche	St-Romuald	Quebec	Canada	G6W 5M6
178	Site CA15025 Clinique RSF Inc.	Quebec		Canada	G1S 2L6
179	Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.	Fuzhou	Fujian	China	350001
180	Site CN86025 Beijing Friendship Hospital	Beijing		China	100050
181	Site CN86009 Peking University 3rd Hospital	Beijing		China	100191
182	Site CN86013 Beijing Hospital	Beijing		China	100730
183	Site CN86014 The First Hospital Bethune of Jilin University	Changchun		China	130021
184	Site CN86002 Changsha Central Hospital	Changsha		China	410008
185	Site CN86028 General Hospital of Chengdu Military Region of PLA	Chengdu		China
186	Site CN86029 Southwest Hospital (Chongqing)	Chongqing		China	400038
187	Site CN86016 Guangzhou First People's Hospital	Guangzhou		China	510180
188	Site CN86027 Second Hospital of Lanzhou University	Lan Zhou		China	730030
189	Site CN86030 Lanzhou University First Hospital	Lanzhou		China
190	Site CN86020 The First Affiliated Hospital of NanChang Univers	Nanchang		China	330006
191	Site CN86023 Nanjing First Hospital	Nanjing		China	210006
192	Site CN86021 HuaDong Hosipital Affiliated to Fudan University	Shanghai		China	200040
193	Site CN86003 Shanghai Renji Hospital	Shanghai		China	200127
194	Site CN86012 The Fifth People's Hospital of Shanghai	Shanghai		China	200240
195	Site CN86011 The Second Affiliated Hospital of Soochow Universi	Suzhou		China	215004
196	Site CN86010 1st Affiliated Hosptital of Suchow University	Suzhou		China	215006
197	Site CN86026 The First Affiliated Hospital of Wenzhou Medical C	Wenzhou		China	325000
198	Site CN86022 Tongji Hospital, Tongji Medical College of Hust	Wuhan		China	430030
199	Site CN86015 Zhongnan Hospital of Wuhan University	Wuhan		China	430071
200	Site CN86018 Wuxi People's Hospital	Wuxi		China	214023
201	Site CO57003 Hospital Pablo Tobón Uribe	Medellin	Antioquia	Colombia
202	Site CO57004 Instituto de Coloproctologia ICO SAS	Medellin		Colombia
203	Site CZ42015 Centrum ambulantni gynekologie a primarni pece	Brno		Czechia	602 00
204	Site CZ42003 SANUS	Hradec Kralove		Czechia	500 02
205	Site CZ42001 Fakultni Nemocnice Hradec Kralove	Hradec Kralove		Czechia	50005
206	Site CZ42002 Hospital Jihlava	Jihlava		Czechia	586 33
207	Site CZ42011 Hospital Novy Jicin	Novy Jicin		Czechia	741 01
208	Site CZ42010 G-centrum Olomouc S.R.O.	Olomouc		Czechia	772 00
209	Site CZ42014 Private Practice	Ostrava		Czechia	700 30
210	Site CZ42005 Research Site s.r.o.	Plzen		Czechia	301 00
211	Site CZ42007 Uro-Santé/Nová Brumlovka	Praha 4		Czechia	140 00
212	Site CZ42013 Urology Clinic	Sternberk		Czechia	78501
213	Site CZ42009 Hospital Uherské Hradiště a.s.	Uherske Hradiste		Czechia	686 08
214	Site CZ42006 Private Practice	Usti nad Labem		Czechia	40001
215	Site DK45012 Aalborg Sygehus Nord	Aalborg		Denmark	9000
216	Site DK45013 University Hospital of Aarhus, Skejby	Aarhus		Denmark	8200
217	Site EE37201 Parnu Hospital	Parnu		Estonia	80010
218	Site EE37205 West Tallinn Central Hospital	Tallinn		Estonia	10617
219	Site EE37202 Tartu University Hospital	Tartu		Estonia	51014
220	Site FI35801 Kouvolan Lääkäriasema	Kouvola		Finland	45200
221	Site FI35803 Oulu University Hospital	Oulu		Finland	90029
222	Site FI35802 Meilahti Hospital	Vantaa		Finland	01400
223	Site FR33007 Centre Hospitalier Louis Pasteur	Colmar Cedex		France	68024
224	Site FR33010 CHU Hopital du Bocage	Dijon		France	21079
225	Site FR33008 CHU Nantes	Nantes Cedex 1		France	44035
226	Site FR33002 CHU Carémeau	Nimes Cedex		France	30029
227	Site FR33001 Hopital Tenon	Paris Cedex 20		France	75970
228	Site FR33024 Hopital Tenon	Paris Cedex 20		France	75970
229	Site FR33013 Hopital Saint Louis	Paris		France	75475
230	Site FR33011 Centre Hospitalier Lyon Sud	Pierre Benite Cedex		France	69495
231	Site FR33012 Hopital Foch	Suresnes		France	92151
232	Site FR33005 Hopital Bretonneau	Tours Cedex 9		France	37044
233	Site DE49008 Private Practice	Bad Ems		Germany	56130
234	Site DE49031 Urologisches Zentrum Refrath	Bergisch Gladbach		Germany	51427
235	Site DE49033 Universitsy Clinic Bonn	Bonn		Germany	53217
236	Site DE49002 Private Practice	Duisburg		Germany	47051
237	Site DE49032 Urologicum Duisburg	Duisburg		Germany	47179
238	Site DE49010 Private Practice	Ganderkesee		Germany	27777
239	Site DE49011 Private Practice	Halle (Saale)		Germany	06132
240	Site DE49013 Private Practice	Leipzig		Germany	04105
241	Site DE49003 Private Practice	Lutherstadt Eisleben		Germany	6295
242	Site DE49034 LMU Muenchen	Munich		Germany	81377
243	Site DE49001 Private Practice	Neustadt I. Sachsen		Germany	1844
244	Site DE49026 Zentrum fuer Onkologie und Urologie Rostock	Rostock		Germany	18107
245	Site DE49014 Private Practice	Sangerhausen		Germany	6526
246	Site GR30009 Aretaieio/Maginio	Athens		Greece	115 28
247	Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital	Hong Kong		Hong Kong
248	Site HK85201 Kwong Wah Hospital	Kowloon		Hong Kong
249	Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital	Shatin		Hong Kong	30-32
250	Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft	Csongrád		Hungary	6640
251	Site HU36007 Mediroyal Prevention Center	Kecskemet		Hungary	6000
252	Site HU36005 Uro-clin Ltd	Pecs		Hungary	7621
253	Site HU36013 Sopron Erzsébet Hospital	Sopron		Hungary	H-9400
254	Site HU36001 Donatella 99BT	Szentes		Hungary	6600
255	Site HU36012 Veszprém County Cholnoky Ferenc Hospital	Veszprém		Hungary	8200
256	Site IT39022 Azienda Ospedale Umberto I (Ancona)	Ancona		Italy	60126
257	Site IT39007 Azienda Ospedaliera San Giuseppe Moscati	Avellino		Italy	83100
258	Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza	Latina		Italy	4100
259	Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia	Milano		Italy	20132
260	Site IT39003 Ospedale San Raffaele	Milan		Italy	20132
261	Site KR82014 Soon Chun Hyang University Hospital	Bucheon-Si		Korea, Republic of	420-767
262	Site KR82006 Dong-A University Medical Center	Busan		Korea, Republic of	602-715
263	Site KR82016 Pusan National University Hospital	Busan		Korea, Republic of	602-739
264	Site KR82024 Chungbuk National University Hospital	Cheongju-si		Korea, Republic of	361-711
265	Site KR82032 Kyungpook National University Hospital	Daegu		Korea, Republic of	700-421
266	Site KR82005 Yeungnam University Hospital	Daegu		Korea, Republic of	705-717
267	Site KR82029 Daegu Catholic Univ. Medical Center	Daegu		Korea, Republic of	705-718
268	Site KR82019 Chungnam National University Hospital	Daejeon		Korea, Republic of	301-721
269	Site KR82011 Eulji University Hospital	Daejeon		Korea, Republic of	302-799
270	Site KR82031 Chonnam National University Hospital	Gwangju		Korea, Republic of	501757
271	Site KR82009 Wonkwang University Hospital	Iksan -Si		Korea, Republic of	570-711
272	Site KR82023 Gachon University Gil Hospital	Incheon		Korea, Republic of	405760
273	Site KR82010 Chonbuk National University Hospital	Jeonju-si		Korea, Republic of	561-712
274	Site KR82025 Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	463-707
275	Site KR82021 Cheil General Hospital & Women's Healthcare Center	Seoul		Korea, Republic of	100-380
276	Site KR82020 Seoul National University Hospital	Seoul		Korea, Republic of	110-744
277	Site KR82030 Severance Hospital	Seoul		Korea, Republic of	120-752
278	Site KR82013 Hallym University Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of	134-701
279	Site KR82017 Kyung Hee University Medical Center	Seoul		Korea, Republic of	134-872
280	Site KR82002 Samsung Medical Center	Seoul		Korea, Republic of	135-710
281	Site KR82008 Gangnam Severance Hospital	Seoul		Korea, Republic of	135-720
282	Site KR82015 Korea University Medical Center	Seoul		Korea, Republic of	136-075
283	Site KR82001 Seoul Saint Mary's Hospital	Seoul		Korea, Republic of	137-040
284	Site KR82003 Asan Medical Center	Seoul		Korea, Republic of	138-736
285	Site KR82012 Konkuk University Medical Center	Seoul		Korea, Republic of	143-729
286	Site KR82004 Ajou University Hospital	Suwon-si		Korea, Republic of	443-721
287	Site LV37102 Private Practice	Liepaja		Latvia	LV-3401
288	Site LV37103 Health Centre "Olaine"	Olaine		Latvia	LV-2114
289	Site LV37105 P.Stradins Clinical University Hospital	Riga		Latvia	1002
290	Site LT37008 Kaunas 2nd Clinical Hospital	Kaunas		Lithuania	47144
291	Site LT37004 KHospital of Lithuanian University of Health Science	Kaunas		Lithuania	50009
292	Site LT37011 Saules Family Medicine Centre	Kaunas		Lithuania
293	Site LT37012 Klaipeda University Hospital	Klaipeda		Lithuania	LT-92288
294	Site LT37005 Public Institution Vilnius City University Hospital	Vilnius		Lithuania	10207
295	Site LT37010 Public Institution Vilnius City University Hospital	Vilnius		Lithuania	10207
296	Site LT37003 Family Medical Centre Seimos gydytojas	Vilnius		Lithuania	LT-01118
297	Site LT37007 Vilnius University Hospital Santariskiu Klinikos	Vilnius		Lithuania	LT-08661
298	Site LT37009 Clinics Privatus gydytojas	Vilnius		Lithuania	LT-09108
299	Site MY60006 Hospital Pulau Pinang	Georgetown		Malaysia	10990
300	Site MY60001 Hospital Kuala Lumpur	Kuala Lumpur		Malaysia	50586
301	Site MY60004 University Malaya Medical Centre	Kuala Lumpur		Malaysia	50603
302	Site MY60005 Universiti Kebangsaan Malaysia Medical Centre	Kuala Lumpur		Malaysia	56000
303	Site MY60003 Hospital Ummum Sarawak	Kuching		Malaysia	93586
304	Site MY60002 Sime Darby Medical Centre	Petaling Jaya		Malaysia	47500
305	Site MX52004 Consultorio de Especialidad en Urologia	Durango		Mexico	34000
306	Site MX52001 Centro de Investigacin Basica y Clnica	Guadalajara		Mexico	45040
307	Site MX52003 Clinstile, Sociedad Anonima de Capital Variable	Mexico City		Mexico	6700
308	Site MX52002 Accelerium Clinical Research/ Hospital San Jorge	Monterrey		Mexico	64000
309	Site NL31002 Academic Medical Center (AMC)	Amsterdam		Netherlands	1105 AZ
310	Site NL31006 Medisch Spectrum Twente	Enschede		Netherlands	7513ER
311	Site NL31005 Canisius-Wilhelmina Ziekenhuis	Nijmegen		Netherlands	6532 SZ
312	Site NL31010 Antonius Ziekenhuis Sneek	Sneek		Netherlands	8601 ZK
313	Site NL31001 University Medical Centre Utrecht	Utrecht		Netherlands	3584 CX
314	Site NZ64004 John A Tuckey Ltd Ascot Central	Auckland		New Zealand	1541
315	Site NZ64001 Canterbury Urology Research Trust	Christchurch		New Zealand	8014
316	Site NZ64005 Waikato Urology Research Limited	Hamilton		New Zealand	3204
317	Site NZ64002 Roundhay Medical Centre	Nelson		New Zealand	7010
318	Site NZ64003 Tauranga Urology Research Ltd	Tauranga		New Zealand	3140
319	Site NZ64006 Cardinal Point Specialist Centre	Whangarei		New Zealand
320	Site NO47006 M3 Helse AS	Hamar		Norway	2317
321	Site NO47008 Norsk Helseklinikk (Heiaklinikken)	Lierskogen		Norway	3420
322	Site NO47007 Medi3 Clinic AS, Ålesund	Ålesund		Norway	6003
323	Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud	La Victoria	Lima	Peru	13
324	Site PE51007 Clínica Anglo Americana	San Isidro	Lima	Peru	27
325	Site PE51001 Instituto de Ginecologia y Reproduccion	Lima		Peru	33
326	Site PE51002 Clinica San Borja	Lima		Peru	41
327	Site PE51004 Clinica San Pablo	Lima		Peru
328	Site PE51005 Hospital Nacional Hipolito Unanue	Lima		Peru
329	Site PH63008 Dr. Pablo O. Torre Memorial Hospital	Bacolod City		Philippines	6100
330	Site PH63005 Davao Doctor's Hospital	Davao City		Philippines	8000
331	Site PH63010 Davao Doctor's Hospital	Davao City		Philippines	8000
332	Site PH63003 University of Santo Tomas Hospital (USTH)	Manila		Philippines	1008
333	Site PH63009 Chinese General Hospital and Medical Center	Manila		Philippines	1008
334	Site PH63004 East Avenue Medical Center	Quezon City		Philippines	1101
335	Site PL48018 Gastromed	Bialystok		Poland	15-351
336	Site PL48013 Urovita Ltd.	Chorzow		Poland	41-500
337	Site PL48014 Synexus Polska	Gdynia		Poland	81-384
338	Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne	Lodz		Poland	90-302
339	Site PL48010 Nzoz Novita	Lublin		Poland	20-632
340	Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.	Myslowice		Poland	41-400
341	Site PL48016 Prywatny Gabinet Urologiczny	Opole		Poland	45-086
342	Site PL48005 HEUREKA Hanna Szalecka	Piaseczno		Poland	05-500
343	Site PL48012 Military Institute of Medicine	Warsaw		Poland	00-909
344	Site PL48003 CSKMSW	Warsaw		Poland	02-507
345	Site PL48001 Specjalistyczny Gabinet Lekarski	Warszawa		Poland	02-929
346	Site PL48019 Synexus Polska sp. z o. o.	Wrocław		Poland	50-088
347	Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov	Brasov		Romania	500152
348	Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan	Bucuresti		Romania	42122
349	Site RO40001 Spiatlul Clinic Th. Burghele	Bucuresti		Romania	50659
350	Site RO40005 Spiatlul Clinic Th. Burghele	Bucuresti		Romania	50659
351	Site RO40014 E-URO Cabinet	Cluj-Napoca		Romania	400046
352	Site RO40007 Spital Clinic	Iasi		Romania	700503
353	Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu	Sibiu		Romania	550245
354	Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara	Timisoara		Romania	300736
355	Site RU70015 LLC Clinical Research Medical Complex	Kazan		Russian Federation	420097
356	Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko	Penza		Russian Federation	440026
357	Site RU70019 City Multidisciplinary Hospital No. 2	Saint Petersburg		Russian Federation	194354
358	Site RU70002 Pavlov St. Petersburg State Medical University	Saint Petersburg		Russian Federation	197089
359	Site RU70022 St. Petersburg State Public Health Institution	Saint Petersburg		Russian Federation	198103
360	Site RU70014 OOO Hospital Orkli	St. Petersburg		Russian Federation	199178
361	Site RU70018 Bashkirsky State Medical University of Roszdrav	Ufa		Russian Federation	450096
362	Site SG65001 National University Hospital	Singapore		Singapore	119074
363	Site SG65002 Singapore General Hospital	Singapore		Singapore	169608
364	Site SG65003 KK Women's and Children's Hospital	Singapore		Singapore	229899
365	Site SK42105 Ruzinovska poliklinika a.s.	Bratislava		Slovakia	82101
366	Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.	Kosice		Slovakia	4001
367	Site SK42101 Andrologicka a Urologicka Ambulancia	Kosice		Slovakia	4013
368	Site SK42103 UroExam s.r.o.	Nitra		Slovakia	949 01
369	Site SK42108 BrenCare, s. r. o.	Poprad		Slovakia	058 01
370	Site SK42104 Urology Outpatient Department	Presov		Slovakia	8001
371	Site SK42106 Private Urological Care Center	Trencin		Slovakia	911 01
372	Site SK42102 CeGys, s.r.o.	Trencin		Slovakia	91101
373	Site SI38604 General Hospital Murska Sobota	Murska Sobota		Slovenia	9000
374	Site SI38602 General Hospital Novo Mesto	Novo Mesto		Slovenia	8000
375	Site ZA27005 Grootte Schuur Hospital	Cape Town		South Africa	7925
376	Site ZA27001 Private Practice	Centurion		South Africa	0157
377	Site ZA27006 Parklands Hospital	Durban		South Africa	4001
378	Site ZA27013 Synexus Clinical Research SA (Pty) Ltd	Meyerspark		South Africa	184
379	Site ZA27007 Paarl Medical Centre	Paarl		South Africa	7646
380	Site ZA27002 Mayo Clinic	Roodepoort		South Africa	1709
381	Site ES34010 Hospital del Henares	Coslada		Spain	28822
382	Site ES34024 Hospital San Juan de Dios	Esplugues De Llobregat-Barcelo		Spain	08950
383	Site ES34001 Hospital Universitario de Getafe	Getafe (Madrid)		Spain	28905
384	Site ES34006 Hospital San Rafael	Madrid		Spain	28016
385	Site ES34004 Hospital Infanta Leonor	Madrid		Spain	28031
386	Site ES34015 Hospital 12 de Octubre	Madrid		Spain	28044
387	Site ES34009 Hospital Universitario La Paz	Madrid		Spain	28046
388	Site ES34005 Hospital de Fuenlabrada	Madrid		Spain	28942
389	Site ES34003 Hospital Universitario Nuestra Señora de Valme	Sevilla		Spain	41001
390	Site ES34007 Hospital Virgen del Rocio	Sevilla		Spain	41013
391	Site ES34002 H. U. Politecnico La Fe	Valencia		Spain	46026
392	Site SE46007 Ladulaas Clinical Studies	Boras		Sweden	506 30
393	Site SE46025 Pharmasite	Helsingborg		Sweden	252 20
394	Site SE46005 Center för Läkemedelsstudier	Malmö		Sweden	211 52
395	Site SE46016 Citydiabetes - Stockholm	Stockholm		Sweden	111 57
396	Site SE46008 Bragée Medect AB	Stockholm		Sweden	115 22
397	Site SE46012 Karolinska University Hospital Huddinge	Stockholm		Sweden	141 86
398	Site SE46003 Danderyds Hospital	Stockholm		Sweden	182 88
399	Site SE46009 Encia AB, Uppsala Hälsomottagning	Uppsala		Sweden	753 35
400	Site SE46017 S3 Clinical Research Centers	Vällingby		Sweden	162 68
401	Site TW88605 Taichung Veteran General Hospital	Taichung		Taiwan	40705
402	Site TW88611 Chung Shan Medical University Hospital	Taichung		Taiwan	407
403	Site TW88612 Chi Mei Medical Center, Yong Kang	Tainan		Taiwan	710
404	Site TW88614 Tri-Service General Hospital	Taipei		Taiwan	114
405	Site TH66002 Chulalongkorn Hospital	Bangkok		Thailand	10330
406	Site TH66008 Phramongkutklao Hospital	Bangkok		Thailand	10400
407	Site TH66005 Siriraj Hospital	Bangkok		Thailand	10700
408	Site TH66010 Maharaj Nakorm Chiangmai Hosp	Chiang Mai		Thailand	50200
409	Site TH66006 Songklanagarind Hospital, Prince of Songkla University	Hat Yai		Thailand	90110
410	Site TH66009 Srinagarind Hospital	Khon Kaen		Thailand	40002
411	Site TH66007 Thammasat University Hospital	Pathum Thani		Thailand	12120
412	Site TH66011 Ramathibodi Hospital	Ratchathewi		Thailand	10400
413	Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital	Ankara		Turkey	06100
414	Site TR90013 Uludag University Faculty of Medicine	Bursa		Turkey	16059
415	Site TR90001 Pamukkale University Faculty of Medicine	Denizli		Turkey	20070
416	Site TR90017 Bilim University Sisli Florence Nightingale Hospital	Istanbul		Turkey	34381
417	Site UA38002 City Hospital No 2	Chernigov		Ukraine	14034
418	Site UA38015 Regional Municipal Institution, Urology Department	Chernivtsi		Ukraine	58000
419	Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov	Dnipropetrovsk		Ukraine	49005
420	Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology	Kharkiv		Ukraine	61037
421	Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric	Kiev		Ukraine	02232
422	Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3	Kyiv		Ukraine	02660
423	Site UA38010 Academy of Medical Sciences of Ukraine	Kyiv		Ukraine	04053
424	Site UA38014 Uzhgorod City Polyclinic	Uzhorod		Ukraine	88000
425	Site UA38004 Vinnitsa Endocrinology Dispens	Vinnytsya		Ukraine	21010
426	Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic	Zaporizhzhya		Ukraine	69600
427	Site GB44009 Sheepcot Medical Centre	Garston	Watfort	United Kingdom	WD25 0EA
428	Site GB44003 Leighton Hospital	Crewe		United Kingdom	CW1 4QJ
429	Site GB44021 Medway Hospital	Gillingham		United Kingdom	ME7 5WY
430	Site GB44005 North West London Hosp Menopause Clinic	Harrow		United Kingdom	HA1 3UJ
431	Site GB44024 St James's University Hospital	Leeds		United Kingdom	LS7 9TF
432	Site GB44025 Kings College Hospital	London		United Kingdom	SE5 9RS
433	Site GB44006 Derriford Hospital	Plymouth		United Kingdom	PL6 8DH
434	Site GB44022 The Royal Berkshire Hospital	Reading		United Kingdom	RG1 5AN
435	Site GB44001 Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF

Sponsors and Collaborators

Astellas Pharma Europe B.V.

Investigators

Study Director: Medical Director, Astellas Pharma Europe B.V.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Link to results on the Astellas Clinical Study Results website

Publications

None provided.

Responsible Party:

Astellas Pharma Europe B.V.

ClinicalTrials.gov Identifier:

NCT01972841

Other Study ID Numbers:

178-CL-101
2012-005735-91
U1111-1153-9095

First Posted:

Oct 31, 2013

Last Update Posted:

Nov 1, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Astellas Pharma Europe B.V.

Solifenacin Succinate

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Urologic Diseases

Urinary Bladder Diseases

Solifenacin Succinate

Mirabegron

Study Results

Participant Flow

Recruitment Details	Patients who had symptoms of "wet" overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled at 435 centers in 42 countries. Eligible participants went into a single-blind, 4-week placebo run-in period and completed a micturition diary the last 7 days prior to each study visit.
Pre-assignment Detail	A total of 6991 participants were screened, 6275 participants received placebo run-in treatment and 3527 participants were randomized into 1 of 6 treatment arms in a 1:1:1:1:2:2 ratio in the 12-week double-blind treatment period. A total of 953 participants were also enrolled in an ambulatory blood pressure monitoring (ABPM) substudy.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Period Title: Overall Study
STARTED	447	441	437	434	885	883
COMPLETED	404	397	387	397	802	798
NOT COMPLETED	43	44	50	37	83	85

Baseline Characteristics

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Total
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.	Total of all reporting groups
Overall Participants	447	441	437	434	885	883	3527
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	57.46 (13.2)	56.77 (13.46)	56.69 (13.28)	57.88 (12.92)	56.94 (13.78)	57.3 (13.46)	57.16 (13.42)
Sex: Female, Male (Count of Participants)
Female	345 77.2%	343 77.8%	338 77.3%	342 78.8%	686 77.5%	684 77.5%	2738 77.6%
Male	102 22.8%	98 22.2%	99 22.7%	92 21.2%	199 22.5%	199 22.5%	789 22.4%
Mean number of incontinence episodes/24 h (incontinence episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [incontinence episodes]	3.41 (3.37)	3.42 (3.40)	3.18 (3.47)	3.58 (3.51)	3.22 (3.17)	3.16 (3.08)	3.29 (3.29)
Mean number of micturitions/24 h (micturitions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [micturitions]	10.97 (2.86)	10.81 (2.63)	11.19 (3.27)	10.76 (2.47)	10.73 (2.88)	10.74 (2.36)	10.84 (2.73)
Mean volume voided per micturition (mL) [Least Squares Mean (Standard Deviation) ]
Least Squares Mean (Standard Deviation) [mL]	157.94 (58.78)	152.46 (60.96)	155.31 (60.78)	151.94 (59.29)	159.32 (58.29)	153.57 (59.67)	155.43 (59.49)
Number of incontinence episodes/week (incontinence episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [incontinence episodes]	23.6 (23.6)	23.5 (23.6)	21.7 (23.8)	24.8 (24.5)	22.1 (21.7)	21.7 (21.3)	22.7 (22.7)
Mean number of urgency incontinence episodes/24 h (urgency incontinence episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [urgency incontinence episodes]	3.14 (3.23)	3.00 (3.09)	2.89 (3.31)	3.23 (3.34)	2.85 (2.81)	2.80 (2.64)	2.94 (3.00)
Number of urgency incontinence episodes/week (urgency incontinence episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [urgency incontinence episodes]	21.7 (22.6)	20.6 (21.4)	19.8 (22.7)	22.4 (23.3)	19.5 (19.3)	19.2 (18.2)	20.3 (20.7)
Mean number of urgency episodes (Grade 3 or 4)/24 h (urgency episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [urgency episodes]	6.52 (4.05)	6.22 (3.89)	6.46 (4.88)	6.48 (3.88)	6.22 (3.70)	6.22 (3.56)	6.32 (3.92)
Mean number of nocturia episodes/24 h (nocturia episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nocturia episodes]	1.57 (1.06)	1.53 (1.02)	1.59 (1.09)	1.59 (0.96)	1.56 (1.07)	1.52 (0.97)	1.56 (1.03)
Number of nocturia episodes/week (nocturia episode) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nocturia episode]	10.9 (7.4)	10.6 (7.1)	11.0 (7.6)	11.0 (6.6)	10.8 (7.4)	10.5 (6.7)	10.8 (7.2)
Mean number of pads used/24 h (pads) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pads]	2.87 (2.99)	2.86 (2.70)	2.62 (3.18)	2.87 (3.14)	2.50 (2.58)	2.58 (2.39)	2.67 (2.76)
Number of pads used/week (pads) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pads]	19.8 (20.9)	19.6 (18.7)	17.9 (21.7)	19.9 (21.8)	17.1 (17.7)	17.7 (16.4)	19.3 (19.0)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Description	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS comprised all RAS patients who took ≥ 1 dose of double-blind treatment after randomization, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from one site. Last observation carried forward (LOCF) was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	412	409	406	413	823	816
Least Squares Mean (Standard Error) [incontinence episodes]	-1.34 (0.10)	-1.70 (0.10)	-1.76 (0.10)	-1.79 (0.10)	-2.04 (0.07)	-1.98 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.072
	Comments	Nominal p-value
	Method	Stratified rank ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95% -0.49 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.033
	Comments	Nominal p-value
	Method	Stratified rank ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95% -0.44 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95% -0.58 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.052
	Comments
	Method	Stratified rank ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95% -0.47 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

2. Primary Outcome

Title	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
Description	A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	412	409	406	413	823	816
Least Squares Mean (Standard Error) [micturitions]	-1.64 (0.12)	-2.00 (0.12)	-2.03 (0.12)	-2.20 (0.12)	-2.49 (0.08)	-2.59 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.040
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95% -0.57 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95% -0.67 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95% -0.76 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95% -0.84 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

3. Secondary Outcome

Title	Change From Baseline to EoT in Mean Volume Voided Per Micturition
Description	The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	413	407	408	411	821	821
Least Squares Mean (Standard Error) [mL]	8.44 (2.55)	13.32 (2.57)	21.99 (2.57)	30.99 (2.56)	34.84 (1.81)	39.73 (1.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.219
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.85
	Confidence Interval	(2-Sided) 95% -2.29 to 10.00
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.13
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	8.75
	Confidence Interval	(2-Sided) 95% 2.61 to 14.89
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.13
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	21.52
	Confidence Interval	(2-Sided) 95% 15.35 to 27.68
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.14
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Nominal p-value
	Method	ANCOVA
	Comments	No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	17.74
	Confidence Interval	(2-Sided) 95% 11.58 to 23.90
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.14
	Estimation Comments	Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.

4. Secondary Outcome

Title	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Description	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	400	392	398	399	800	795
Least Squares Mean (Standard Error) [units on a scale]	-19.45 (0.98)	-23.93 (0.99)	-26.14 (0.98)	-26.44 (0.98)	-31.06 (0.69)	-32.24 (0.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-4.63
	Confidence Interval	(2-Sided) 95% -6.98 to -2.27
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.20
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-5.80
	Confidence Interval	(2-Sided) 95% -8.17 to -3.44
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.21
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-7.13
	Confidence Interval	(2-Sided) 95% -9.50 to -4.76
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.21
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-6.10
	Confidence Interval	(2-Sided) 95% -8.46 to -3.74
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.20
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Description	The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	399	391	398	399	798	794
Least Squares Mean (Standard Error) [units on a scale]	1.42 (0.11)	2.16 (0.11)	2.18 (0.11)	2.28 (0.11)	2.53 (0.08)	2.55 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.077
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95% -0.03 to 0.52
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.050
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95% 0.00 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95% 0.10 to 0.65
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments	No adjustment for multiplicity was made for this comparison.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95% 0.10 to 0.65
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments

6. Secondary Outcome

Title	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
Description	The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	18.09 (1.17)	15.65 (1.08)	12.90 (1.06)	15.31 (1.11)	12.51 (0.67)	11.44 (0.70)
Week 8	14.45 (1.12)	12.84 (1.05)	11.31 (1.09)	12.19 (1.06)	9.70 (0.65)	9.33 (0.68)
Week 12	14.06 (1.17)	10.60 (0.98)	9.50 (0.98)	11.25 (1.03)	7.62 (0.57)	8.21 (0.68)
End of treatment	13.70 (1.08)	11.19 (0.95)	9.79 (0.94)	11.21 (0.98)	8.02 (0.55)	8.18 (0.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.135
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95% 0.72 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.09
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.282
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% 0.75 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.09
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.59 to 0.85
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.09
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.172
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95% 0.73 to 1.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.10
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
Description
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-5.23 (0.66)	-7.59 (0.66)	-8.99 (0.67)	-8.92 (0.67)	-9.62 (0.47)	-10.51 (0.47)
Week 8	-8.79 (0.71)	-10.57 (0.72)	-10.97 (0.72)	-11.89 (0.72)	-12.53 (0.50)	-12.78 (0.51)
Week 12	-9.05 (0.72)	-12.33 (0.72)	-12.58 (0.72)	-12.75 (0.71)	-14.50 (0.51)	-13.94 (0.51)
End of treatment	-9.42 (0.68)	-11.93 (0.68)	-12.39 (0.68)	-12.65 (0.68)	-14.29 (0.48)	-13.98 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.074
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	least squares mean difference
	Estimated Value	-1.64
	Confidence Interval	(2-Sided) 95% -3.27 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.83
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.33
	Confidence Interval	(2-Sided) 95% -2.96 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.83
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	least square mean difference
	Estimated Value	-2.36
	Confidence Interval	(2-Sided) 95% -4.00 to -0.73
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.83
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.59
	Confidence Interval	(2-Sided) 95% -3.23 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.84
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Description
Time Frame	Baseline and weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-0.74 (0.10)	-1.07 (0.10)	-1.24 (0.10)	-1.24 (0.10)	-1.38 (0.07)	-1.50 (0.07)
Week 8	-1.20 (0.10)	-1.51 (0.10)	-1.57 (0.10)	-1.66 (0.10)	-1.79 (0.07)	-1.84 (0.07)
Week 12	-1.30 (0.11)	-1.76 (0.11)	-1.81 (0.11)	-1.80 (0.10)	-2.08 (0.07)	-1.98 (0.07)

9. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
Description
Time Frame	Baseline and weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point data were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-1.02 (0.11)	-1.46 (0.11)	-1.44 (0.11)	-1.39 (0.11)	-1.67 (0.08)	-1.91 (0.08)
Week 8	-1.43 (0.11)	-1.95 (0.12)	-1.89 (0.12)	-1.84 (0.12)	-2.23 (0.08)	-2.42 (0.08)
Week 12	-1.51 (0.12)	-2.01 (0.12)	-2.03 (0.12)	-2.22 (0.12)	-2.47 (0.08)	-2.60 (0.08)

10. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
Description
Time Frame	Baseline and weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	6.95 (2.13)	10.08 (2.14)	15.52 (2.14)	24.23 (2.15)	25.54 (1.51)	28.99 (1.51)
Week 8	9.00 (2.48)	10.96 (2.52)	17.73 (2.53)	27.55 (2.50)	32.94 (1.78)	36.51 (1.77)
Week 12	8.70 (2.70)	12.88 (2.74)	22.40 (2.73)	31.89 (2.68)	35.52 (1.90)	41.28 (1.90)

11. Secondary Outcome

Title	Change From Baseline to EoT in Corrected Micturition Frequency
Description	Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
FAS. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	412	409	406	413	823	816
Least Squares Mean (Standard Error) [micturitions]	0.15 (0.24)	-0.17 (0.24)	-0.97 (0.24)	-1.28 (0.24)	-1.10 (0.17)	-1.52 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.520
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95% -0.39 to 0.76
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.29
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.413
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95% -0.82 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.29
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.92
	Confidence Interval	(2-Sided) 95% -1.50 to -0.34
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.29
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.060
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean diffrence
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95% -1.13 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.30
	Estimation Comments

12. Secondary Outcome

Title	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
Description	An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	15.76 (1.10)	13.36 (0.99)	11.46 (1.00)	13.19 (1.06)	10.22 (0.58)	9.33 (0.58)
Week 8	12.77 (1.07)	10.65 (0.94)	10.09 (1.02)	10.41 (1.00)	7.58 (0.53)	7.31 (0.54)
Week 12	12.00 (1.09)	8.84 (0.89)	8.32 (0.94)	9.29 (0.96)	5.86 (0.46)	6.27 (0.49)
End of treatment	11.69 (1.00)	9.37 (0.86)	8.63 (0.89)	9.29 (0.91)	6.25 (0.45)	6.15 (0.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.110
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95% 0.70 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.10
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.288
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% 0.73 to 1.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.10
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95% 0.53 to 0.79
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.10
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.084
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95% 0.68 to 1.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.10
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
Description
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-5.49 (0.63)	-7.07 (0.63)	-8.39 (0.63)	-8.53 (0.63)	-9.44 (0.44)	-10.23 (0.44)
Week 8	-8.30 (0.66)	-9.93 (0.67)	-10.07 (0.67)	-11.10 (0.67)	-12.18 (0.47)	-12.18 (0.47)
Week 12	-8.96 (0.65)	-11.39 (0.66)	-11.66 (0.66)	-12.10 (0.65)	-13.87 (0.46)	-13.53 (0.46)
End of treatment	-9.26 (0.62)	-11.03 (0.62)	-11.44 (0.62)	-12.03 (0.62)	-13.64 (0.44)	-13.64 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.114
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.61
	Confidence Interval	(2-Sided) 95% -3.09 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.76
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.62
	Confidence Interval	(2-Sided) 95% -3.10 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.76
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-2.61
	Confidence Interval	(2-Sided) 95% -4.09 to -1.12
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.76
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-2.21
	Confidence Interval	(2-Sided) 95% -3.70 to -0.71
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.76
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description	The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-0.78 (0.09)	-1.00 (0.09)	-1.15 (0.09)	-1.19 (0.09)	-1.35 (0.06)	-1.47 (0.06)
Week 8	-1.15 (0.10)	-1.43 (0.10)	-1.44 (0.10)	-1.56 (0.10)	-1.74 (0.07)	-1.79 (0.07)
Week 12	-1.29 (0.10)	-1.63 (0.10)	-1.67 (0.10)	-1.72 (0.10)	-1.99 (0.07)	-1.93 (0.07)
End of treatment	-1.33 (0.09)	-1.58 (0.09)	-1.62 (0.09)	-1.71 (0.09)	-1.95 (0.06)	-1.94 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.134
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95% -0.46 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.11
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95% -0.45 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.11
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean diffeence
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95% -0.59 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.11
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Stratified rank ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Standard Error of the Mean
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 05% -0.54 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.11
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Description	An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency episode at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-1.34 (0.15)	-1.95 (0.14)	-1.91 (0.15)	-2.14 (0.15)	-2.42 (0.10)	-2.66 (0.10)
Week 8	-1.85 (0.15)	-2.54 (0.15)	-2.43 (0.15)	-2.90 (0.15)	-3.13 (0.11)	-3.28 (0.11)
Week 12	-2.05 (0.16)	-2.85 (0.16)	-2.70 (0.16)	-3.11 (0.16)	-3.45 (0.11)	-3.50 (0.11)
End of treatment	-2.06 (0.15)	-2.74 (0.15)	-2.63 (0.15)	-3.05 (0.15)	-3.38 (0.11)	-3.51 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.074
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95% -0.69 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95% -0.82 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95% -1.01 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95% -1.24 to 0.51
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

16. Secondary Outcome

Title	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
Description	A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	9.62 (0.43)	8.46 (0.36)	9.11 (0.47)	9.22 (0.42)	8.40 (0.25)	8.09 (0.25)
Week 8	8.99 (0.44)	8.07 (0.34)	8.61 (0.45)	8.37 (0.38)	7.63 (0.25)	7.11 (0.24)
Week 12	8.91 (0.43)	7.99 (0.37)	8.34 (0.48)	8.17 (0.39)	7.26 (0.24)	6.67 (0.23)
End of treatment	8.83 (0.42)	7.79 (0.35)	8.14 (0.45)	8.12 (0.37)	7.33 (0.24)	6.67 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95% 0.81 to 0.96
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% 0.74 to 0.88
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.049
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95% 0.84 to 1.00
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95% 0.79 to 0.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

17. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
Description
Time Frame	Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-1.27 (0.27)	-2.25 (0.28)	-1.80 (0.27)	-1.79 (0.28)	-2.39 (0.19)	-2.50 (0.19)
Week 8	-1.94 (0.27)	-2.70 (0.28)	-2.41 (0.28)	-2.60 (0.28)	-3.13 (0.20)	-3.48 (0.20)
Week 12	-1.95 (0.29)	-2.77 (0.30)	-2.73 (0.29)	-2.89 (0.29)	-3.49 (0.21)	-3.96 (0.21)
End of treatment	-2.05 (0.27)	-2.91 (0.28)	-2.75 (0.28)	-2.81 (0.28)	-3.42 (0.20)	-3.96 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.073
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 95% -1.28 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.34
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.16
	Confidence Interval	(2-Sided) 95% -1.83 to -0.48
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.34
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.140
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95% -1.18 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.34
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 95% -1.88 to -0.54
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.34
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Description	The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-0.17 (0.04)	-0.31 (0.04)	-0.25 (0.04)	-0.24 (0.04)	-0.33 (0.03)	-0.35 (0.03)
Week 8	-0.27 (0.04)	-0.37 (0.04)	-0.35 (0.04)	-0.36 (0.04)	-0.44 (0.03)	-0.50 (0.03)
Week 12	-0.26 (0.04)	-0.38 (0.04)	-0.39 (0.04)	-0.41 (0.04)	-0.49 (0.03)	-0.56 (0.03)
End of treatmemt	-0.27 (0.04)	-0.40 (0.04)	-0.39 (0.04)	-0.39 (0.04)	-0.48 (0.03)	-0.56 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.065
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95% -0.19 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95% -0.26 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.100
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95% -0.18 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95% -0.26 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

19. Secondary Outcome

Title	Number of Pads Used at Weeks 4, 8, 12 and EoT
Description	The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Weeks 4, 8 and 12 (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	15.62 (1.33)	13.46 (1.24)	10.05 (1.21)	11.41 (1.23)	9.71 (0.70)	9.34 (0.68)
Week 8	12.75 (1.22)	10.79 (1.05)	9.53 (1.39)	8.45 (1.03)	8.07 (0.65)	7.58 (0.62)
Week 12	12.62 (1.21)	9.65 (1.00)	8.44 (1.26)	8.21 (0.95)	6.60 (0.58)	6.64 (0.61)
End of treatment	12.29 (1.11)	10.15 (0.97)	8.16 (1.17)	8.53 (0.94)	7.04 (0.56)	6.80 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.938
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95% 0.80 to 1.27
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.967
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95% 0.79 to 1.25
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Standard Error of the Mean
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95% 0.58 to 0.92
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.069
	Comments
	Method	Negative binomial regression
	Comments

Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95% 0.64 to 1.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.12
	Estimation Comments

20. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
Description
Time Frame	Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-3.69 (0.71)	-5.68 (0.71)	-7.83 (0.71)	-8.23 (0.70)	-7.61 (0.50)	-8.58 (0.50)
Week 8	-6.24 (0.77)	-8.44 (0.77)	-8.43 (0.76)	-10.67 (0.76)	-9.49 (0.54)	-10.59 (0.54)
Week 12	-6.29 (0.75)	-9.06 (0.75)	-9.41 (0.75)	-10.80 (0.73)	-10.66 (0.52)	-11.23 (0.53)
End of treatment	-6.60 (0.71)	-8.76 (0.71)	-9.80 (0.72)	-10.63 (0.70)	-10.67 (0.50)	-11.21 (0.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.958
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95% -1.73 to 1.64
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.86
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.500
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95% -2.27 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.86
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.91
	Confidence Interval	(2-Sided) 95% -3.62 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.87
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.108
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.41
	Confidence Interval	(2-Sided) 95% -3.13 to 0.31
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.88
	Estimation Comments

21. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
Description	The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Time Frame	Baseline and weeks 4, 8 and 12 (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-0.52 (0.10)	-0.81 (0.10)	-1.12 (0.10)	-1.19 (0.10)	-1.09 (0.07)	-1.23 (0.07)
Week 8	-0.82 (0.11)	-1.20 (0.11)	-1.24 (0.11)	-1.53 (0.11)	-1.36 (0.08)	-1.51 (0.08)
Week 12	-0.92 (0.11)	-1.30 (0.11)	-1.37 (0.11)	-1.56 (0.11)	-1.54 (0.08)	-1.59 (0.08)
End of treatment	-0.94 (0.10)	-1.26 (0.10)	-1.41 (0.10)	-1.53 (0.10)	-1.53 (0.07)	-1.58 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.993
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95% -0.25 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.650
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95% -0.30 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.27
	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 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.169
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95% -0.43 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments

22. Secondary Outcome

Title	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
Description	The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	2.25 (0.13)	2.48 (0.13)	2.98 (0.13)	2.74 (0.14)	3.08 (0.10)	3.37 (0.10)
Week 8	2.92 (0.14)	3.17 (0.14)	3.63 (0.15)	3.31 (0.14)	3.88 (0.10)	4.01 (0.10)
Week 12	3.19 (0.15)	3.69 (0.15)	3.96 (0.15)	3.68 (0.14)	4.33 (0.10)	4.25 (0.10)
End of treatment	3.16 (0.14)	3.51 (0.14)	3.89 (0.14)	3.61 (0.14)	4.20 (0.10)	4.23 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.37
	Confidence Interval	(2-Sided) 95% 1.11 to 1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.36
	Confidence Interval	(2-Sided) 95% 1.11 to 1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95% 1.29 to 1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.36
	Confidence Interval	(2-Sided) 95% 1.10 to 1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
Description	The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.
Time Frame	Weeks 4, 8,12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	1.49 (0.10)	1.74 (0.10)	1.55 (0.10)	1.86 (0.11)	2.07 (0.08)	2.11 (0.08)
Week 8	1.69 (0.10)	2.08 (0.12)	1.99 (0.11)	2.22 (0.12)	2.59 (0.09)	2.70 (0.09)
Week 12	1.76 (0.11)	2.31 (0.13)	2.25 (0.12)	2.49 (0.13)	2.87 (0.09)	2.95 (0.10)
End of treatment	1.80 (0.11)	2.28 (0.12)	2.22 (0.12)	2.49 (0.12)	2.84 (0.09)	2.92 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95% 1.01 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95% 1.07 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95% 1.19 to 1.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 95% 1.23 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
Description	The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	0.64 (0.07)	0.84 (0.08)	0.87 (0.08)	0.91 (0.08)	1.21 (0.07)	1.32 (0.07)
Week 8	0.85 (0.08)	1.20 (0.10)	1.23 (0.10)	1.31 (0.10)	1.75 (0.08)	1.89 (0.08)
Week 12	0.98 (0.09)	1.47 (0.11)	1.50 (0.11)	1.60 (0.11)	2.12 (0.09)	2.15 (0.09)
End of treatment	1.01 (0.08)	1.40 (0.10)	1.47 (0.10)	1.59 (0.10)	2.04 (0.08)	2.12 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% 1.07 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 95% 1.14 to 1.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.65
	Confidence Interval	(2-Sided) 95% 1.32 to 2.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Overdispersed binomial regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.66
	Confidence Interval	(2-Sided) 95% 1.33 to 2.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
Description	The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time Frame	Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT .

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-0.54 (0.06)	-0.72 (0.06)	-0.83 (0.06)	-0.81 (0.06)	-0.99 (0.04)	-1.07 (0.04)
Week 8	-0.80 (0.06)	-1.07 (0.06)	-1.12 (0.06)	-1.18 (0.06)	-1.32 (0.04)	-1.48 (0.04)
Week 12	-0.95 (0.06)	-1.23 (0.06)	-1.34 (0.06)	-1.32 (0.06)	-1.57 (0.04)	-1.72 (0.04)
End of treatment	-0.91 (0.06)	-1.18 (0.06)	-1.31 (0.06)	-1.27 (0.06)	-1.53 (0.04)	-1.66 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95% -0.41 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95% -0.54 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95% -0.50 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95% -0.50 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.07
	Estimation Comments

26. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
Description	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time Frame	Baseline and weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	-13.84 (0.92)	-17.05 (0.93)	-18.98 (0.93)	-19.53 (0.93)	-23.46 (0.65)	-25.19 (0.65)
Week 8	-17.35 (0.98)	-22.79 (0.99)	-23.54 (0.98)	-24.69 (0.97)	-29.10 (0.69)	-30.04 (0.69)
Week 12	-19.94 (1.01)	-24.44 (1.02)	-26.80 (1.02)	-26.72 (1.01)	-31.70 (0.72)	-33.15 (0.72)

27. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score
Description	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	10.16 (0.83)	13.54 (0.83)	15.28 (0.83)	14.78 (0.83)	17.46 (0.58)	17.95 (0.59)
Week 8	14.51 (0.88)	17.95 (0.89)	18.54 (0.88)	18.57 (0.88)	22.30 (0.62)	22.45 (0.62)
Week 12	15.76 (0.92)	19.59 (0.93)	21.48 (0.92)	20.54 (0.91)	24.63 (0.65)	24.93 (0.65)
End of treatment	15.37 (0.88)	18.94 (0.89)	21.00 (0.89)	20.15 (0.89)	23.96 (0.63)	24.30 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.81
	Confidence Interval	(2-Sided) 95% 1.69 to 5.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.08
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.16
	Confidence Interval	(2-Sided) 95% 2.03 to 6.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.09
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.02
	Confidence Interval	(2-Sided) 95% 2.88 to 7.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.09
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.30
	Confidence Interval	(2-Sided) 95% 1.17 to 5.43
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.09
	Estimation Comments

28. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
Description	The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	11.74 (0.99)	14.87 (1.00)	17.68 (1.00)	16.52 (1.00)	19.31 (0.70)	20.36 (0.70)
Week 8	16.13 (1.04)	20.64 (1.05)	21.52 (1.04)	21.69 (1.03)	25.49 (0.74)	25.85 (0.73)
Week 12	18.17 (1.09)	22.04 (1.10)	24.94 (1.10)	23.67 (1.09)	28.32 (0.77)	29.03 (0.78)
End of treatment	17.73 (1.05)	21.28 (1.06)	24.32 (1.05)	23.25 (1.05)	27.37 (0.74)	28.12 (0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.12
	Confidence Interval	(2-Sided) 95% 1.60 to 6.65
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.29
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Lest squares mean difference
	Estimated Value	4.87
	Confidence Interval	(2-Sided) 95% 2.34 to 7.40
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.29
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	6.09
	Confidence Interval	(2-Sided) 95% 3.55 to 8.63
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.30
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.80
	Confidence Interval	(2-Sided) 95% 1.27 to 6.33
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.29
	Estimation Comments

29. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
Description	The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	11.24 (0.95)	15.89 (0.96)	17.39 (0.95)	17.18 (0.95)	20.48 (0.67)	21.09 (0.67)
Week 8	16.10 (0.99)	20.63 (1.01)	20.55 (1.00)	20.96 (0.99)	25.26 (0.71)	25.65 (0.70)
Week 12	17.53 (1.03)	22.37 (1.04)	23.62 (1.04)	23.19 (1.03)	27.53 (0.73)	28.24 (0.73)
End of treatment	16.98 (1.00)	21.55 (1.01)	23.07 (1.00)	22.65 (1.00)	26.89 (0.71)	27.47 (0.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.24
	Confidence Interval	(2-Sided) 95% 1.84 to 6.63
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.22
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.82
	Confidence Interval	(2-Sided) 95% 2.42 to 7.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.34
	Confidence Interval	(2-Sided) 95% 2.93 to 7.75
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.23
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.41
	Confidence Interval	(2-Sided) 95% 2.01 to 6.81
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.22
	Estimation Comments

30. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
Description	The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	9.28 (0.95)	12.70 (0.96)	13.80 (0.96)	13.08 (0.96)	15.97 (0.68)	16.66 (0.68)
Week 8	13.58 (1.03)	16.39 (1.05)	17.33 (1.03)	16.43 (1.03)	20.29 (0.73)	20.49 (0.73)
Week 12	14.40 (1.05)	18.04 (1.06)	19.16 (1.06)	18.35 (1.05)	22.97 (0.74)	22.76 (0.75)
End of treatment	14.17 (1.01)	17.51 (1.02)	19.11 (1.02)	17.97 (1.01)	22.39 (0.72)	22.39 (0.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.42
	Confidence Interval	(2-Sided) 95% 1.98 to 6.85
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.42
	Confidence Interval	(2-Sided) 95% 1.98 to 6.86
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.87
	Confidence Interval	(2-Sided) 95% 2.42 to 7.32
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.25
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.28
	Confidence Interval	(2-Sided) 95% 0.84 to 5.72
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.24
	Estimation Comments

31. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
Description	The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	7.07 (0.78)	9.04 (0.79)	10.19 (0.78)	9.89 (0.78)	11.55 (0.55)	11.25 (0.55)
Week 8	10.65 (0.82)	11.50 (0.83)	12.34 (0.82)	12.02 (0.81)	14.89 (0.58)	14.73 (0.58)
Week 12	10.84 (0.83)	13.43 (0.84)	15.35 (0.84)	13.74 (0.83)	16.16 (0.59)	16.08 (0.59)
End of treatment	10.56 (0.81)	13.04 (0.81)	14.87 (0.81)	13.57 (0.81)	15.84 (0.57)	15.82 (0.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	2.27
	Confidence Interval	(2-Sided) 95% 0.33 to 4.21
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.99
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	2.25
	Confidence Interval	(2-Sided) 95% 0.31 to 4.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.99
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	2.80
	Confidence Interval	(2-Sided) 95% 0.85 to 4.74
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.99
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.337
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95% -0.99 to 2.89
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.99
	Estimation Comments

32. Secondary Outcome

Title	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
Description	The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Time Frame	Week 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 12: Very much improved	8.4 1.9%	13.9 3.2%	15.1 3.5%	13.5 3.1%	19.8 2.2%	27.1 3.1%
Week 12: Much improved	29.7 6.6%	32.9 7.5%	34.8 8%	40.5 9.3%	39.8 4.5%	34.0 3.9%
Week 12: Minimally improved	29.7 6.6%	26.8 6.1%	26.5 6.1%	25.8 5.9%	22.2 2.5%	20.7 2.3%
Week 12: No change	17.5 3.9%	12.9 2.9%	9.7 2.2%	8.9 2.1%	7.7 0.9%	7.3 0.8%
Week 12: Minimally worse	4.1 0.9%	1.5 0.3%	2.2 0.5%	1.7 0.4%	0.8 0.1%	0.8 0.1%
Week 12: Much worse	1.0 0.2%	1.0 0.2%	1.2 0.3%	0.5 0.1%	0.2 0%	0 0%
Week 12: Very much worse	0.5 0.1%	0.5 0.1%	0.7 0.2%	0.5 0.1%	0.2 0%	0.5 0.1%
EoT: Very much improved	8.4 1.9%	13.9 3.2%	15.1 3.5%	13.5 3.1%	20.0 2.3%	27.1 3.1%
EoT: Much improved	30.4 6.8%	33.2 7.5%	34.8 8%	41.0 9.4%	40.0 4.5%	34.6 3.9%
EoT: Minimally improved	29.9 6.7%	26.8 6.1%	27.0 6.2%	26.3 6.1%	22.6 2.6%	21.3 2.4%
EoT: No change	18.2 4.1%	13.4 3%	10.2 2.3%	9.6 2.2%	7.9 0.9%	7.4 0.8%
EoT: Minimally worse	4.1 0.9%	1.5 0.3%	2.2 0.5%	1.7 0.4%	0.8 0.1%	0.8 0.1%
EoT: Much worse	1.0 0.2%	1.0 0.2%	1.2 0.3%	0.7 0.2%	0.4 0%	0 0%
EoT: Very much worse	0.5 0.1%	0.5 0.1%	0.7 0.2%	0.5 0.1%	0.2 0%	0.6 0.1%

33. Secondary Outcome

Title	PGIC Scale: Impression in General Health at Week 12 and EoT
Description	The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Time Frame	Week 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 12: Very much improved	4.8 1.1%	8.0 1.8%	7.3 1.7%	7.7 1.8%	10.3 1.2%	14.6 1.7%
Week 12: Much improved	23.9 5.3%	28.0 6.3%	29.2 6.7%	31.8 7.3%	33.4 3.8%	30.2 3.4%
Week 12: Minimally improved	23.9 5.3%	21.5 4.9%	22.4 5.1%	24.1 5.6%	20.1 2.3%	20.9 2.4%
Week 12: No change	31.8 7.1%	27.8 6.3%	27.5 6.3%	25.3 5.8%	23.9 2.7%	21.6 2.4%
Week 12: Minimally worse	4.3 1%	2.9 0.7%	2.2 0.5%	1.4 0.3%	2.5 0.3%	2.2 0.2%
Week 12: Much worse	1.7 0.4%	0.7 0.2%	1.2 0.3%	0.5 0.1%	0.5 0.1%	0.1 0%
Week 12: Very much worse	0.2 0%	0.5 0.1%	0.5 0.1%	0.5 0.1%	0.2 0%	0.6 0.1%
End of treatment: Very much improved	4.8 1.1%	8.0 1.8%	7.3 1.7%	7.7 1.8%	10.3 1.2%	14.6 1.7%
End of treatment: Much improved	24.2 5.4%	28.0 6.3%	29.2 6.7%	31.8 7.3%	33.6 3.8%	30.4 3.4%
End of treatment: Minimally improved	24.4 5.5%	21.5 4.9%	22.9 5.2%	24.1 5.6%	20.2 2.3%	21.3 2.4%
End of treatment:No change	32.3 7.2%	28.3 6.4%	27.7 6.3%	26.5 6.1%	24.3 2.7%	21.9 2.5%
End of treatment: Minimally worse	4.3 1%	2.9 0.7%	2.4 0.5%	1.9 0.4%	2.8 0.3%	2.7 0.3%
End of treatment: Much worse	1.9 0.4%	0.7 0.2%	1.2 0.3%	0.5 0.1%	0.5 0.1%	0.2 0%
End of treatment: Very much worse	0.5 0.1%	0.7 0.2%	0.5 0.1%	0.7 0.2%	0.2 0%	0.7 0.1%

34. Secondary Outcome

Title	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
Description	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
No problems -> no problems	204 45.6%	239 54.2%	225 51.5%	227 52.3%	449 50.7%	452 51.2%
No problems -> slight problems	16 3.6%	20 4.5%	25 5.7%	22 5.1%	41 4.6%	38 4.3%
No problems -> moderate problems	11 2.5%	12 2.7%	9 2.1%	8 1.8%	20 2.3%	10 1.1%
No problems -> severe problems	1 0.2%	3 0.7%	3 0.7%	1 0.2%	1 0.1%	2 0.2%
No problems -> unable to walk about	0 0%	1 0.2%	0 0%	0 0%	0 0%	1 0.1%
No problems -> no data	2 0.4%	4 0.9%	5 1.1%	4 0.9%	6 0.7%	9 1%
Slight problems -> no problems	33 7.4%	35 7.9%	35 8%	30 6.9%	76 8.6%	60 6.8%
Slight problems -> slight problems	27 6%	20 4.5%	24 5.5%	19 4.4%	40 4.5%	49 5.5%
Slight problems -> moderate problems	11 2.5%	6 1.4%	4 0.9%	6 1.4%	19 2.1%	9 1%
Slight problems -> severe problems	5 1.1%	0 0%	3 0.7%	1 0.2%	2 0.2%	2 0.2%
Slight problems -> unable to walk about	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Slight problems -> no data	2 0.4%	3 0.7%	0 0%	0 0%	0 0%	2 0.2%
Moderate problems -> no problems	17 3.8%	7 1.6%	25 5.7%	18 4.1%	31 3.5%	46 5.2%
Moderate problems -> slight problems	18 4%	10 2.3%	10 2.3%	22 5.1%	24 2.7%	25 2.8%
Moderate problems -> moderate problems	21 4.7%	12 2.7%	10 2.3%	13 3%	33 3.7%	35 4%
Moderate problems -> severe problems	10 2.2%	5 1.1%	4 0.9%	2 0.5%	8 0.9%	10 1.1%
Moderate problems -> unable to walk about	0 0%	0 0%	0 0%	1 0.2%	1 0.1%	1 0.1%
Moderate problems -> no data	1 0.2%	1 0.2%	0 0%	1 0.2%	0 0%	2 0.2%
Severe problems -> no problems	3 0.7%	5 1.1%	9 2.1%	7 1.6%	12 1.4%	17 1.9%
Severe problems -> slight problems	6 1.3%	7 1.6%	3 0.7%	4 0.9%	13 1.5%	8 0.9%
Severe problems -> moderate problems	5 1.1%	4 0.9%	8 1.8%	8 1.8%	15 1.7%	15 1.7%
Severe problems -> severe problems	8 1.8%	5 1.1%	1 0.2%	8 1.8%	11 1.2%	13 1.5%
Severe problems -> unable to walk about	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe problems -> no data	0 0%	0 0%	2 0.5%	1 0.2%	1 0.1%	0 0%
Unable to walk about -> no problems	0 0%	0 0%	0 0%	2 0.5%	2 0.2%	0 0%
Unable to walk about -> slight problems	1 0.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Unable to walk about -> moderate problems	1 0.2%	0 0%	0 0%	0 0%	0 0%	1 0.1%
Unable to walk about -> severe problems	1 0.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Unable to walk about -> unable to walk about	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unable to walk about -> no data	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no problems	12 2.7%	7 1.6%	3 0.7%	6 1.4%	15 1.7%	16 1.8%
No data -> slight problems	1 0.2%	0 0%	1 0.2%	2 0.5%	4 0.5%	2 0.2%
No data -> moderate problems	0 0%	3 0.7%	1 0.2%	0 0%	0 0%	2 0.2%
No data -> severe problems	0 0%	1 0.2%	0 0%	2 0.5%	2 0.2%	0 0%
No data -> unable to walk about	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no data	1 0.2%	0 0%	1 0.2%	0 0%	1 0.1%	0 0%

35. Secondary Outcome

Title	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
Description	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
No problems -> no problems	311 69.6%	324 73.5%	336 76.9%	319 73.5%	652 73.7%	647 73.3%
No problems -> slight problems	21 4.7%	17 3.9%	9 2.1%	20 4.6%	22 2.5%	26 2.9%
No problems -> moderate problems	9 2%	5 1.1%	6 1.4%	3 0.7%	12 1.4%	4 0.5%
No problems -> severe problems	0 0%	0 0%	1 0.2%	1 0.2%	1 0.1%	1 0.1%
No problems -> unable to wash/dress myself	1 0.2%	0 0%	1 0.2%	0 0%	0 0%	0 0%
No problems -> no data	4 0.9%	8 1.8%	6 1.4%	5 1.2%	6 0.7%	12 1.4%
Slight problems -> no problems	17 3.8%	13 2.9%	16 3.7%	25 5.8%	35 4%	33 3.7%
Slight problems -> slight problems	10 2.2%	10 2.3%	12 2.7%	12 2.8%	22 2.5%	26 2.9%
Slight problems -> moderate problems	2 0.4%	4 0.9%	1 0.2%	2 0.5%	3 0.3%	7 0.8%
Slight problems -> severe problems	2 0.4%	0 0%	0 0%	0 0%	1 0.1%	2 0.2%
Slight problems -> unable to wash/dress myself	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Slight problems -> no data	1 0.2%	0 0%	0 0%	1 0.2%	1 0.1%	0 0%
Moderate problems -> no problems	6 1.3%	8 1.8%	3 0.7%	2 0.5%	17 1.9%	18 2%
Moderate problems -> slight problems	3 0.7%	1 0.2%	8 1.8%	3 0.7%	9 1%	7 0.8%
Moderate problems -> moderate problems	9 2%	1 0.2%	2 0.5%	6 1.4%	8 0.9%	9 1%
Moderate problems -> severe problems	0 0%	0 0%	0 0%	0 0%	2 0.2%	1 0.1%
Moderate problems -> unable to wash/dress myself	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Moderate problems -> no data	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.1%
Severe problems -> no problems	2 0.4%	2 0.5%	2 0.5%	1 0.2%	3 0.3%	4 0.5%
Severe problems -> slight problems	1 0.2%	0 0%	0 0%	3 0.7%	3 0.3%	3 0.3%
Severe problems -> moderate problems	1 0.2%	2 0.5%	0 0%	0 0%	7 0.8%	3 0.3%
Severe problems -> severe problems	3 0.7%	3 0.7%	0 0%	1 0.2%	1 0.1%	0 0%
Severe problems -> unable to wash/dress myself	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe problems -> no data	0 0%	0 0%	1 0.2%	0 0%	0 0%	0 0%
Unable to wash/dress myself -> no problems	0 0%	1 0.2%	1 0.2%	0 0%	0 0%	3 0.3%
Unable to wash/dress myself -> slight problems	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unable to wash/dress myself -> moderate problems	1 0.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Unable to wash/dress myself -> severe problems	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unable to wash/dress myself -> unable to w/d	0 0%	0 0%	0 0%	1 0.2%	0 0%	0 0%
Unable to wash/dress myself -> no data	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no problems	13 2.9%	8 1.8%	3 0.7%	8 1.8%	20 2.3%	18 2%
No data -> slight problems	0 0%	2 0.5%	2 0.5%	1 0.2%	1 0.1%	0 0%
No data -> moderate problems	0 0%	1 0.2%	0 0%	1 0.2%	0 0%	2 0.2%
No data -> severe problems	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> unable to wash/dress myself	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no data	1 0.2%	0 0%	1 0.2%	0 0%	1 0.1%	0 0%

36. Secondary Outcome

Title	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
Description	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
No problems -> No problems	196 43.8%	228 51.7%	219 50.1%	223 51.4%	434 49%	451 51.1%
No problems -> Slight problems	37 8.3%	25 5.7%	28 6.4%	25 5.8%	37 4.2%	48 5.4%
No problems -> Moderate problems	9 2%	5 1.1%	9 2.1%	8 1.8%	13 1.5%	11 1.2%
No problems -> Severe problems	2 0.4%	0 0%	1 0.2%	0 0%	1 0.1%	1 0.1%
No problems -> unable to do usual activities	0 0%	0 0%	0 0%	0 0%	1 0.1%	1 0.1%
No problems -> no data	2 0.4%	5 1.1%	4 0.9%	3 0.7%	5 0.6%	8 0.9%
Slight problems -> no problems	45 10.1%	41 9.3%	52 11.9%	52 12%	98 11.1%	95 10.8%
Slight problems -> slight problems	28 6.3%	29 6.6%	23 5.3%	25 5.8%	64 7.2%	56 6.3%
Slight problems -> moderate problems	15 3.4%	9 2%	3 0.7%	8 1.8%	18 2%	12 1.4%
Slight problems -> severe problems	2 0.4%	0 0%	2 0.5%	0 0%	2 0.2%	3 0.3%
Slight problems ->unable to do usual activities	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Slight problems -> no data	2 0.4%	2 0.5%	0 0%	3 0.7%	2 0.2%	4 0.5%
Moderate problems -> no problems	14 3.1%	13 2.9%	15 3.4%	13 3%	44 5%	26 2.9%
Moderate problems -> slight problems	12 2.7%	9 2%	16 3.7%	14 3.2%	29 3.3%	30 3.4%
Moderate problems -> moderate problems	15 3.4%	11 2.5%	9 2.1%	12 2.8%	25 2.8%	17 1.9%
Moderate problems -> severe problems	1 0.2%	3 0.7%	0 0%	1 0.2%	3 0.3%	3 0.3%
Moderate problems ->unable to do usual activities	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.1%
Moderate problems -> no data	1 0.2%	1 0.2%	2 0.5%	0 0%	0 0%	1 0.1%
Severe problems -> no problems	7 1.6%	3 0.7%	7 1.6%	6 1.4%	7 0.8%	11 1.2%
Severe problems -> slight problems	3 0.7%	4 0.9%	6 1.4%	2 0.5%	8 0.9%	8 0.9%
Severe problems -> moderate problems	6 1.3%	7 1.6%	5 1.1%	6 1.4%	9 1%	7 0.8%
Severe problems -> severe problems	4 0.9%	1 0.2%	1 0.2%	3 0.7%	2 0.2%	9 1%
Severe problems -> unable to do usual activities	0 0%	1 0.2%	0 0%	0 0%	0 0%	0 0%
Severe problems -> no data	0 0%	0 0%	1 0.2%	0 0%	0 0%	0 0%
Unable to do usual activities -> no problems	0 0%	1 0.2%	0 0%	0 0%	0 0%	2 0.2%
Unable to do usual activities -> slight problems	1 0.2%	0 0%	0 0%	0 0%	1 0.1%	1 0.1%
Unable to do usual activities -> moderate problems	2 0.4%	1 0.2%	1 0.2%	0 0%	1 0.1%	1 0.1%
Unable to do usual activities -> severe problems	0 0%	0 0%	1 0.2%	0 0%	0 0%	0 0%
Unable to do usual activities -> unable to do usu.	0 0%	0 0%	0 0%	1 0.2%	1 0.1%	0 0%
Unable to do usual activities -> no data	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no problems	12 2.7%	7 1.6%	2 0.5%	7 1.6%	18 2%	15 1.7%
No data -> slight problems	1 0.2%	2 0.5%	3 0.7%	1 0.2%	1 0.1%	3 0.3%
No data -> moderate problems	0 0%	2 0.5%	0 0%	2 0.5%	2 0.2%	2 0.2%
No data -> severe problems	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> unable to do usual activities	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no data	1 0.2%	0 0%	1 0.2%	0 0%	1 0.1%	0 0%

37. Secondary Outcome

Title	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
Description	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
No pain/discomfort -> no pain/discomfort	131 29.3%	175 39.7%	153 35%	154 35.5%	290 32.8%	317 35.9%
No pain/discomfort -> slight pain/discomfort	38 8.5%	29 6.6%	37 8.5%	33 7.6%	74 8.4%	51 5.8%
No pain/discomfort -> moderate pain/discomfort	10 2.2%	9 2%	17 3.9%	13 3%	19 2.1%	20 2.3%
No pain/discomfort -> severe pain/discomfort	0 0%	0 0%	3 0.7%	3 0.7%	3 0.3%	1 0.1%
No pain/discomfort -> extreme pain/discomfort	0 0%	0 0%	0 0%	0 0%	1 0.1%	0 0%
No pain/discomfort -> no data	2 0.4%	3 0.7%	4 0.9%	2 0.5%	3 0.3%	8 0.9%
Slight pain/discomfort -> no pain/discomfort	53 11.9%	51 11.6%	44 10.1%	46 10.6%	117 13.2%	105 11.9%
Slight pain/discomfort -> slight pain/discomfort	54 12.1%	49 11.1%	45 10.3%	47 10.8%	94 10.6%	101 11.4%
Slight pain/discomfort -> moderate pain/discomfort	12 2.7%	11 2.5%	14 3.2%	18 4.1%	15 1.7%	19 2.2%
Slight pain/discomfort -> severe pain/discomfort	3 0.7%	0 0%	2 0.5%	0 0%	6 0.7%	3 0.3%
Slight pain/discomfort -> exteme pain/discomfort	2 0.4%	0 0%	1 0.2%	0 0%	0 0%	0 0%
Slight pain/discomfort -> no data	2 0.4%	5 1.1%	2 0.5%	2 0.5%	2 0.2%	4 0.5%
Moderate pain/discomfort -> no pain/discomfort	20 4.5%	14 3.2%	24 5.5%	23 5.3%	45 5.1%	46 5.2%
Moderate pain/discomfort -> slight pain/discomfort	23 5.1%	15 3.4%	20 4.6%	22 5.1%	46 5.2%	45 5.1%
Moderate pain/discomfort -> moderate pain/discomf	31 6.9%	13 2.9%	16 3.7%	15 3.5%	34 3.8%	40 4.5%
Moderate pain/discomfort -> severe pain/discomfort	4 0.9%	5 1.1%	3 0.7%	1 0.2%	4 0.5%	6 0.7%
Moderate pain/discomfort -> extreme pain/discomf	0 0%	0 0%	0 0%	0 0%	1 0.1%	0 0%
Moderate pain/discomfort -> no data	1 0.2%	0 0%	0 0%	1 0.2%	1 0.1%	1 0.1%
Severe pain/discomfort -> no pain/discomfort	2 0.4%	4 0.9%	3 0.7%	1 0.2%	8 0.9%	12 1.4%
Severe pain/discomfort -> slight pain/discomfort	3 0.7%	4 0.9%	6 1.4%	4 0.9%	11 1.2%	7 0.8%
Severe pain/discomfort -> moderate pain/discomfort	8 1.8%	4 0.9%	6 1.4%	11 2.5%	15 1.7%	11 1.2%
Severe pain/discomfort -> severe pain/discomfort	4 0.9%	3 0.7%	1 0.2%	4 0.9%	7 0.8%	8 0.9%
Severe pain/discomfort -> extreme pain/discomfort	0 0%	1 0.2%	1 0.2%	0 0%	1 0.1%	0 0%
Severe pain/discomfort -> no data	0 0%	0 0%	1 0.2%	0 0%	1 0.1%	0 0%
Extreme pain/discomfort -> no pain/discomfort	0 0%	0 0%	0 0%	0 0%	1 0.1%	0 0%
Extreme pain/discomfort -> slight pain/discomfort	1 0.2%	0 0%	0 0%	2 0.5%	1 0.1%	1 0.1%
Extreme pain/discomfort -> moderate pain/discom.	0 0%	2 0.5%	1 0.2%	0 0%	1 0.1%	1 0.1%
Extreme pain/discomfort -> severe pain/discomfort	0 0%	2 0.5%	1 0.2%	2 0.5%	3 0.3%	0 0%
Extreme pain/discomfort -> extreme pain/discomfort	0 0%	0 0%	0 0%	0 0%	1 0.1%	0 0%
Extreme pain/discomfort -> no data	0 0%	0 0%	0 0%	1 0.2%	0 0%	0 0%
No data -> no pain/discomfort	11 2.5%	5 1.1%	3 0.7%	6 1.4%	14 1.6%	14 1.6%
No data -> slight pain/discomfort	2 0.4%	2 0.5%	2 0.5%	2 0.5%	6 0.7%	3 0.3%
No data -> moderate pain/discomfort	0 0%	4 0.9%	0 0%	2 0.5%	1 0.1%	3 0.3%
No data -> severe pain/discomfort	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> extreme pain/discomfort	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> no data	1 0.2%	0 0%	1 0.2%	0 0%	1 0.1%	0 0%

38. Secondary Outcome

Title	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
Description	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time Frame	Baseline and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Not anxious -> not anxious	157 35.1%	176 39.9%	187 42.8%	166 38.2%	360 40.7%	370 41.9%
Not anxious -> slightly anxious	42 9.4%	27 6.1%	25 5.7%	29 6.7%	45 5.1%	50 5.7%
Not anxious -> moderately anxious	7 1.6%	6 1.4%	6 1.4%	8 1.8%	13 1.5%	11 1.2%
Not anxious -> severely anxious	0 0%	2 0.5%	5 1.1%	1 0.2%	2 0.2%	1 0.1%
Not anxious -> extremely anxious	0 0%	0 0%	1 0.2%	0 0%	0 0%	1 0.1%
Not anxious -> no data	2 0.4%	3 0.7%	2 0.5%	1 0.2%	3 0.3%	6 0.7%
Slightly anxious -> not anxious	42 9.4%	60 13.6%	54 12.4%	59 13.6%	122 13.8%	134 15.2%
Slightly anxious -> slightly anx	49 11%	40 9.1%	45 10.3%	40 9.2%	79 8.9%	65 7.4%
Slightly anxious -> moderately anxious	17 3.8%	16 3.6%	12 2.7%	17 3.9%	18 2%	16 1.8%
Slightly anxious -> severely anxious	4 0.9%	2 0.5%	2 0.5%	2 0.5%	5 0.6%	5 0.6%
Slightly anxious -> extremely anxious	0 0%	0 0%	0 0%	0 0%	1 0.1%	0 0%
Slightly anxious -> no data	2 0.4%	3 0.7%	2 0.5%	5 1.2%	3 0.3%	4 0.5%
Moderately anxious -> not anxious	12 2.7%	13 2.9%	12 2.7%	22 5.1%	42 4.7%	35 4%
Moderately anxious -> slightly anxious	19 4.3%	17 3.9%	19 4.3%	14 3.2%	43 4.9%	41 4.6%
Moderately anxious -> moderately anxious	17 3.8%	7 1.6%	11 2.5%	10 2.3%	18 2%	23 2.6%
Moderately anxious -> severely anxious	2 0.4%	3 0.7%	0 0%	1 0.2%	8 0.9%	7 0.8%
Moderately anxious -> extremely anxious	0 0%	1 0.2%	0 0%	0 0%	1 0.1%	1 0.1%
Moderately anxious -> no data	1 0.2%	1 0.2%	2 0.5%	0 0%	1 0.1%	3 0.3%
Severely anxious -> not anxious	7 1.6%	5 1.1%	6 1.4%	6 1.4%	12 1.4%	8 0.9%
Severely anxious -> slightly anxious	3 0.7%	3 0.7%	4 0.9%	5 1.2%	11 1.2%	6 0.7%
Severely anxious -> moderately anxious	5 1.1%	7 1.6%	2 0.5%	6 1.4%	6 0.7%	7 0.8%
Severely anxious -> severely anxious	10 2.2%	1 0.2%	2 0.5%	5 1.2%	5 0.6%	2 0.2%
Severely anxious -> extremely anxious	1 0.2%	0 0%	0 0%	1 0.2%	0 0%	3 0.3%
Severely anxious -> no data	0 0%	1 0.2%	1 0.2%	0 0%	0 0%	0 0%
Extremely anxious -> not anxious	2 0.4%	1 0.2%	0 0%	0 0%	2 0.2%	1 0.1%
Extremely anxious -> slightly anxious	2 0.4%	2 0.5%	1 0.2%	2 0.5%	2 0.2%	3 0.3%
Extremely anxious -> moderately anxious	1 0.2%	1 0.2%	1 0.2%	1 0.2%	2 0.2%	1 0.1%
Extremely anxious -> severely anxious	0 0%	1 0.2%	1 0.2%	3 0.7%	0 0%	1 0.1%
Extremely anxious -> extremely anxious	0 0%	0 0%	2 0.5%	1 0.2%	1 0.1%	2 0.2%
Extremely anxious -> no data	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No data -> not anxious	9 2%	8 1.8%	3 0.7%	6 1.4%	13 1.5%	14 1.6%
No data -> slightly anxious	4 0.9%	1 0.2%	2 0.5%	2 0.5%	6 0.7%	3 0.3%
No data -> moderately anxious	0 0%	2 0.5%	0 0%	2 0.5%	1 0.1%	2 0.2%
No data -> severely anxious	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.1%
No data -> extremely anxious	0 0%	0 0%	0 0%	0 0%	1 0.1%	0 0%
No data -> no data	1 0.2%	0 0%	1 0.2%	0 0%	1 0.1%	0 0%

39. Secondary Outcome

Title	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
Description	The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Time Frame	Baseline and week 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 12	-2.98 (21.70)	-0.33 (22.03)	-1.72 (18.70)	-2.47 (14.13)	-2.06 (20.93)	-2.59 (19.65)
End of treatment	-2.96 (21.61)	-0.33 (22.03)	-1.71 (18.64)	-2.44 (14.03)	-1.48 (21.95)	-2.55 (19.54)

40. Secondary Outcome

Title	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
Description
Time Frame	Baseline and week 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 12	-11.27 (25.36)	-14.96 (26.21)	-12.25 (25.06)	-10.85 (25.58)	-14.69 (26.99)	-13.07 (27.35)
End of treatment	-11.18 (25.28)	-14.96 (26.21)	-12.37 (25.01)	-10.98 (25.68)	-14.58 (26.92)	-12.87 (27.31)

41. Secondary Outcome

Title	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
Description
Time Frame	Baseline and week 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 12	-12.23 (25.66)	-15.70 (26.54)	-12.92 (26.71)	-12.31 (26.91)	-16.31 (29.06)	-13.97 (29.30)
End of treatment	-12.14 (25.58)	-15.70 (26.54)	-13.05 (26.65)	-12.42 (26.98)	-16.07 (29.12)	-13.76 (29.25)

42. Secondary Outcome

Title	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
Description
Time Frame	Baseline and week 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 12	-11.49 (27.31)	-16.89 (27.57)	-14.99 (27.81)	-16.19 (29.16)	-19.60 (28.80)	-18.92 (29.47)
End of treatment	-11.55 (27.19)	-16.72 (27.82)	-15.05 (27.95)	-16.05 (28.95)	-19.45 (28.80)	-18.76 (29.33)

43. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
Description	The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time Frame	Baseline and week 4, 8 and 12

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	1.14 (0.12)	1.68 (0.12)	1.77 (0.12)	1.82 (0.12)	2.06 (0.08)	2.13 (0.08)
Week 8	1.50 (0.11)	2.16 (0.12)	2.09 (0.11)	2.20 (0.11)	2.48 (0.08)	2.48 (0.08)
Week 12	1.47 (0.12)	2.24 (0.12)	2.23 (0.12)	2.32 (0.12)	2.58 (0.08)	2.63 (0.08)

44. Secondary Outcome

Title	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	23.2	24.9	27.6	28.9	35.1	37.3
Week 8	28.7	35.3	40.7	38.3	45.3	48.2
Week 12	38.0	42.5	47.4	42.7	52.3	52.7
End of treatment	37.6	40.6	46.3	42.9	50.7	52.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% 1.02 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95% 1.09 to 1.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 95% 1.16 to 1.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.34
	Confidence Interval	(2-Sided) 95% 1.04 to 1.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

45. Secondary Outcome

Title	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	56.4 12.6%	62.6 14.2%	69.9 16%	73.9 17%	73.9 8.4%	75.8 8.6%
Week 8	62.2 13.9%	71.6 16.2%	73.4 16.8%	79.2 18.2%	83.9 9.5%	82.8 9.4%
Week 12	66.0 14.8%	72.1 16.3%	78.4 17.9%	82.4 19%	83.5 9.4%	85.1 9.6%
End of treatment	65.3 14.6%	71.2 16.1%	77.1 17.6%	81.2 18.7%	82.8 9.4%	84.3 9.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.224
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95% 0.88 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.037
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.42
	Confidence Interval	(2-Sided) 95% 1.02 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.98
	Confidence Interval	(2-Sided) 95% 1.47 to 2.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.65
	Confidence Interval	(2-Sided) 95% 1.21 to 2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

46. Secondary Outcome

Title	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	45.3 10.1%	52.8 12%	59.7 13.7%	61.7 14.2%	62.9 7.1%	61.3 6.9%
Week 8	51.2 11.5%	62.2 14.1%	65.3 14.9%	66.2 15.3%	71.5 8.1%	69.3 7.8%
Week 12	57.7 12.9%	62.4 14.1%	69.1 15.8%	71.7 16.5%	76.3 8.6%	71.8 8.1%
End of treatment	56.8 12.7%	61.0 13.8%	68.3 15.6%	71.2 16.4%	74.5 8.4%	71.1 8.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.077
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95% 0.97 to 1.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.321
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95% 0.87 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95% 1.46 to 2.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.294
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95% 0.88 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

47. Secondary Outcome

Title	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	41.1 9.2%	45.3 10.3%	56.7 13%	53.2 12.3%	57.2 6.5%	60.6 6.9%
Week 8	54.9 12.3%	61.8 14%	63.7 14.6%	65.3 15%	69.8 7.9%	70.6 8%
Week 12	58.6 13.1%	66.4 15.1%	70.2 16.1%	71.0 16.4%	75.9 8.6%	76.1 8.6%
End of treatment	59.5 13.3%	64.5 14.6%	69.0 15.8%	70.5 16.2%	74.5 8.4%	75.7 8.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.251
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95% 0.89 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.107
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95% 0.95 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95% 1.23 to 2.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 95% 1.08 to 1.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

48. Secondary Outcome

Title	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8 , 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	24.1 5.4%	30.8 7%	25.4 5.8%	31.1 7.2%	36.0 4.1%	37.7 4.3%
Week 8	28.7 6.4%	37.9 8.6%	34.5 7.9%	37.0 8.5%	45.3 5.1%	49.0 5.5%
Week 12	29.7 6.6%	42.3 9.6%	40.7 9.3%	44.9 10.3%	50.8 5.7%	53.1 6%
End of treatment	31.1 7%	42.1 9.5%	40.1 9.2%	45.0 10.4%	51.3 5.8%	52.6 6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.044
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95% 1.01 to 1.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.43
	Confidence Interval	(2-Sided) 95% 1.11 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.47
	Confidence Interval	(2-Sided) 95% 1.13 to 1.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.60
	Confidence Interval	(2-Sided) 95% 1.23 to 2.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

49. Secondary Outcome

Title	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	12.8 2.9%	13.1 3%	16.7 3.8%	17.7 4.1%	23.9 2.7%	26.0 2.9%
Week 8	19.1 4.3%	24.4 5.5%	29.8 6.8%	28.2 6.5%	36.6 4.1%	38.4 4.3%
Week 12	29.1 6.5%	32.2 7.3%	35.0 8%	31.9 7.4%	42.4 4.8%	43.7 4.9%
End of treatment	28.6 6.4%	30.6 6.9%	34.0 7.8%	31.5 7.3%	40.9 4.6%	43.1 4.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.47
	Confidence Interval	(2-Sided) 95% 1.13 to 1.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.62
	Confidence Interval	(2-Sided) 95% 1.24 to 2.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95% 1.22 to 2.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.57
	Confidence Interval	(2-Sided) 95% 1.21 to 2.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

50. Secondary Outcome

Title	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	48.9 10.9%	52.8 12%	60.3 13.8%	58.1 13.4%	63.1 7.1%	62.7 7.1%
Week 8	56.4 12.6%	65.3 14.8%	69.7 15.9%	72.7 16.8%	71.6 8.1%	75.4 8.5%
Week 12	59.8 13.4%	66.9 15.2%	73.8 16.9%	74.1 17.1%	76.6 8.7%	80.0 9.1%
End of treaetment	59.8 13.4%	65.4 14.8%	72.4 16.6%	71.9 16.6%	75.7 8.6%	78.4 8.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.065
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% 0.98 to 1.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95% 1.24 to 2.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.76
	Confidence Interval	(2-Sided) 95% 1.32 to 2.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.51
	Confidence Interval	(2-Sided) 95% 1.12 to 2.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

51. Secondary Outcome

Title	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
Description	The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	15.9 3.6%	20.6 4.7%	22.4 5.1%	27.4 6.3%	31.1 3.5%	31.1 3.5%
Week 8	27.0 6%	33.3 7.6%	35.0 8%	40.5 9.3%	42.7 4.8%	46.4 5.3%
Week 12	29.6 6.6%	39.0 8.8%	42.3 9.7%	44.5 10.3%	50.7 5.7%	52.9 6%
End of treatment	29.5 6.6%	37.2 8.4%	40.7 9.3%	42.6 9.8%	49.7 5.6%	51.2 5.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) 95% 1.11 to 1.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.67
	Confidence Interval	(2-Sided) 95% 1.28 to 2.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.76
	Confidence Interval	(2-Sided) 95% 1.34 to 2.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95% 1.29 to 2.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

52. Secondary Outcome

Title	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
Description	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	28.6 6.4%	34.8 7.9%	45.7 10.5%	44.9 10.3%	47.8 5.4%	52.3 5.9%
Week 8	39.8 8.9%	50.0 11.3%	51.5 11.8%	56.5 13%	63.1 7.1%	63.5 7.2%
Week 12	45.0 10.1%	55.7 12.6%	59.4 13.6%	63.1 14.5%	66.7 7.5%	69.5 7.9%
End of treatment	45.2 10.1%	54.0 12.2%	58.2 13.3%	62.6 14.4%	65.2 7.4%	68.2 7.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.381
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95% 0.87 to 1.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.040
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% 1.01 to 1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95% 1.21 to 2.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.57
	Confidence Interval	(2-Sided) 95% 1.21 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

53. Secondary Outcome

Title	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
Description	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	23.2 5.2%	28.3 6.4%	39.8 9.1%	37.7 8.7%	40.4 4.6%	40.5 4.6%
Week 8	32.9 7.4%	43.2 9.8%	46.1 10.5%	48.4 11.2%	54.1 6.1%	53.0 6%
Week 12	39.2 8.8%	48.3 11%	53.5 12.2%	54.8 12.6%	61.6 7%	59.2 6.7%
End of treatment	39.1 8.7%	46.0 10.4%	52.9 12.1%	54.0 12.4%	59.0 6.7%	58.2 6.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.095
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95% 0.96 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.073
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95% 0.98 to 1.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.66
	Confidence Interval	(2-Sided) 95% 1.29 to 2.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.067
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.27
	Confidence Interval	(2-Sided) 95% 0.98 to 1.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

54. Secondary Outcome

Title	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Description	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	23.2 5.2%	27.9 6.3%	37.7 8.6%	34.5 7.9%	39.9 4.5%	42.9 4.9%
Week 8	35.6 8%	44.7 10.1%	50.1 11.5%	51.3 11.8%	53.8 6.1%	57.7 6.5%
Week 12	40.6 9.1%	51.7 11.7%	54.9 12.6%	56.9 13.1%	62.0 7%	65.4 7.4%
End of treatment	40.9 9.1%	48.5 11%	53.9 12.3%	56.0 12.9%	59.9 6.8%	63.8 7.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.210
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95% 0.91 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 95% 1.13 to 1.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95% 1.23 to 2.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95% 1.23 to 2.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

55. Secondary Outcome

Title	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Description	The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	17.8 4%	24.0 5.4%	33.6 7.7%	31.4 7.2%	37.5 4.2%	40.2 4.6%
Week 8	29.7 6.6%	41.3 9.4%	43.2 9.9%	47.8 11%	51.6 5.8%	54.7 6.2%
Week 12	35.8 8%	47.7 10.8%	49.6 11.4%	54.5 12.6%	58.2 6.6%	62.0 7%
End of treatment	36.1 8.1%	45.0 10.2%	48.4 11.1%	53.3 12.3%	56.3 6.4%	60.3 6.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.335
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95% 0.88 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95% 1.09 to 1.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95% 1.21 to 2.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.71
	Confidence Interval	(2-Sided) 95% 1.33 to 2.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

56. Secondary Outcome

Title	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
Description	The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Time Frame	Weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	418	410	411	415	827	827
Week 4	15.2 3.4%	20.6 4.7%	30.0 6.9%	28.6 6.6%	32.7 3.7%	33.4 3.8%
Week 8	24.9 5.6%	36.9 8.4%	38.9 8.9%	43.0 9.9%	46.3 5.2%	46.8 5.3%
Week 12	33.3 7.4%	42.0 9.5%	45.6 10.4%	49.9 11.5%	54.5 6.2%	54.2 6.1%
End of treatment	33.3 7.4%	39.1 8.9%	44.8 10.3%	49.2 11.3%	51.6 5.8%	52.8 6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.416
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95% 0.86 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.105
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95% 0.96 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 25 mg, Solifenacin 5 mg + Mirabegron 25 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.66
	Confidence Interval	(2-Sided) 95% 1.28 to 2.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
	Comments	Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Logistic regression
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95% 1.12 to 1.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

57. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.
Time Frame	From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set (SAF), which comprised all randomized participants who received ≥ 1 dose of double-blind treatment and excluded participants from one site.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	429	423	422	423	853	848
Any TEAE	145 32.4%	135 30.6%	147 33.6%	149 34.3%	345 39%	314 35.6%
Drug-related TEAEs	45 10.1%	37 8.4%	52 11.9%	63 14.5%	157 17.7%	150 17%
Deaths	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Serious TEAEs	8 1.8%	6 1.4%	5 1.1%	3 0.7%	12 1.4%	19 2.2%
Drug-related serious TEAEs	0 0%	1 0.2%	1 0.2%	0 0%	2 0.2%	3 0.3%
TEAEs leading to discontinuation	9 2%	7 1.6%	10 2.3%	7 1.6%	20 2.3%	22 2.5%
Drug-related TEAEs leading to discontinuation	7 1.6%	4 0.9%	6 1.4%	5 1.2%	17 1.9%	19 2.2%

58. Secondary Outcome

Title	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
Description	PVR volume was assessed by ultrasonography or a bladder scanner.
Time Frame	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
SAF participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	429	423	422	423	853	848
Week 4	-0.8 (29.9)	1.6 (28.0)	-2.1 (29.7)	5.8 (35.6)	7.2 (47.7)	10.6 (51.1)
Week 8	-1.9 (28.6)	-0.4 (29.8)	-0.6 (34.4)	5.4 (35.2)	7.0 (37.4)	9.9 (46.0)
Week 12	-1.0 (29.9)	1.0 (29.8)	0.0 (30.1)	4.7 (33.1)	7.9 (44.4)	9.6 (50.1)
End of treatment	-1.0 (29.4)	0.7 (29.1)	-0.8 (30.0)	4.8 (33.3)	9.0 (55.0)	11.0 (54.9)

59. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
Description	Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPM analysis set (ABPMAS), which consisted of all participants in the SAF for whom at least 1 ABPM variable could be calculated at baseline and postbaseline visit. Participants with data available at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4: 24-hour mean	-1.00 (1.22)	-2.04 (1.31)	0.96 (1.30)	1.03 (1.26)	-0.85 (0.90)	0.31 (0.85)
Week 4: mean daytime	-1.55 (1.22)	-1.19 (1.33)	-0.67 (1.31)	-1.13 (1.34)	-1.63 (0.91)	-0.53 (0.85)
Week 4: mean nighttime	-0.51 (1.38)	-1.14 (1.46)	1.42 (1.44)	0.41 (1.47)	1.14 (1.03)	0.54 (0.98)
Week 12: 24-hour mean	-1.97 (1.37)	-2.70 (1.42)	-1.75 (1.41)	0.40 (1.45)	-0.71 (1.02)	0.40 (0.95)
Week 12: mean daytime	-2.22 (1.37)	-2.53 (1.46)	-2.14 (1.48)	-2.09 (1.50)	-0.39 (1.06)	-0.71 (1.02)
Week 12: mean nighttime	-1.03 (1.64)	-2.81 (1.77)	-0.77 (1.68)	1.31 (1.76)	0.11 (1.23)	0.79 (1.17)
End of treatment: 24-hour mean	-1.73 (1.24)	-3.44 (1.29)	-1.14 (1.27)	0.37 (1.25)	-0.52 (0.90)	-0.08 (0.85)
End of treatment: mean daytime	-2.01 (1.22)	-3.29 (1.31)	-1.92 (1.30)	-2.17 (1.30)	-0.68 (0.92)	-1.28 (0.87)
End of treatment: mean nighttime	-1.00 (1.47)	-3.48 (1.54)	-0.60 (1.52)	1.42 (1.52)	0.41 (1.09)	0.91 (1.04)

60. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
Description	Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4: 24-hour mean	-0.70 (0.50)	-0.86 (0.54)	0.22 (0.54)	0.25 (0.52)	0.03 (0.37)	0.38 (0.35)
Week 4: mean daytime	-1.25 (0.53)	-0.36 (0.58)	-0.33 (0.57)	-0.77 (0.58)	-0.40 (0.40)	0.07 (0.37)
Week 4: mean nighttime	-0.12 (0.59)	-0.97 (0.62)	0.40 (0.62)	0.48 (0.63)	0.93 (0.44)	0.47 (0.42)
Week 12: 24-hour mean	-0.80 (0.56)	-0.93 (0.58)	-0.19 (0.57)	0.43 (0.59)	-0.37 (0.41)	0.31 (0.39)
Week 12: mean daytime	-0.85 (0.60)	-0.54 (0.64)	-0.40 (0.65)	-0.33 (0.66)	-0.06 (0.46)	-0.18 (0.44)
Week 12: mean nighttime	-0.49 (0.66)	-1.39 (0.71)	-0.03 (0.68)	0.92 (0.71)	0.23 (0.49)	0.49 (0.47)
End of treatment: 24-hour mean	-0.96 (0.51)	-1.41 (0.53)	-0.11 (0.52)	0.05 (0.52)	-0.02 (0.37)	0.25 (0.35)
End of treatment: mean daytime	-1.17 (0.53)	-0.98 (0.58)	-0.69 (0.57)	-0.79 (0.57)	-0.18 (0.40)	-0.36 (0.38)
End of treatment: mean nighttime	-0.41 (0.60)	-2.00 (0.63)	0.08 (0.63)	0.71 (0.63)	0.56 (0.45)	0.61 (0.43)

61. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4: 24-hour mean	-0.83 (0.63)	1.14 (0.68)	2.32 (0.67)	0.36 (0.65)	0.40 (0.46)	0.69 (0.44)
Week 4: mean daytime	-0.70 (0.73)	1.19 (0.79)	3.52 (0.78)	0.37 (0.80)	-0.05 (0.54)	0.61 (0.51)
Week 4: mean nighttime	-0.72 (0.68)	0.98 (0.71)	1.77 (0.70)	1.09 (0.72)	0.86 (0.50)	0.86 (0.48)
Week 12: 24-hour mean	0.70 (0.72)	0.38 (0.74)	1.19 (0.74)	0.12 (0.76)	0.94 (0.53)	1.44 (0.50)
Week 12: mean daytime	0.89 (0.82)	0.25 (0.88)	2.12 (0.89)	-0.13 (0.90)	0.84 (0.64)	1.36 (0.61)
Week 12: mean nighttime	0.34 (0.71)	0.21 (0.77)	0.19 (0.73)	0.06 (0.76)	0.76 (0.53)	1.52 (0.51)
End of treatment: 24-hour mean	0.41 (0.65)	0.63 (0.68)	1.67 (0.67)	0.02 (0.66)	0.85 (0.47)	1.52 (0.45)
End of treatment: mean daytime	0.45 (0.74)	0.37 (0.80)	2.64 (0.79)	-0.07 (0.79)	0.32 (0.56)	1.24 (0.53)
End of treatment: mean nighttime	0.39 (0.66)	0.82 (0.69)	0.75 (0.68)	0.45 (0.68)	1.21 (0.49)	1.64 (0.47)

62. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	-2.71 (1.68)	0.34 (1.86)	-1.03 (1.72)	-1.77 (1.74)	-1.55 (1.23)	-1.47 (1.17)
Week 12	-4.86 (1.78)	-2.13 (1.95)	-1.64 (1.88)	-3.15 (1.96)	-0.26 (1.32)	0.60 (1.32)
End of treatment	-4.40 (1.60)	-2.19 (1.68)	-1.94 (1.64)	-3.64 (1.65)	-0.61 (1.16)	-0.98 (1.12)

63. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	-1.24 (0.84)	0.09 (0.93)	-0.65 (0.86)	-0.48 (0.87)	-0.22 (0.62)	-0.71 (0.58)
Week 12	-1.74 (0.92)	-0.45 (1.00)	-0.31 (0.97)	-1.49 (1.01)	0.48 (0.68)	-0.03 (0.68)
End of treatment	-1.85 (0.84)	-0.71 (0.88)	-0.71 (0.85)	-1.22 (0.86)	0.44 (0.61)	-0.80 (0.59)

64. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	0.02 (1.08)	2.39 (1.19)	3.68 (1.10)	0.47 (1.11)	-0.91 (0.79)	0.67 (0.75)
Week 12	0.10 (1.10)	1.22 (1.20)	1.87 (1.16)	0.37 (1.21)	0.15 (0.81)	1.39 (0.81)
End of treatment	-0.43 (1.05)	0.82 (1.10)	3.41 (1.07)	-1.25 (1.08)	0.34 (0.76)	1.25 (0.73)

65. Secondary Outcome

Title	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	34.05 (2.06)	31.14 (2.20)	38.20 (2.19)	35.16 (2.11)	32.88 (1.51)	32.80 (1.43)
Week 12	33.21 (2.30)	30.68 (2.38)	32.88 (2.36)	35.11 (2.42)	33.53 (1.70)	32.82 (1.59)
End of treatment	34.98 (2.11)	30.65 (2.20)	33.53 (2.16)	34.95 (2.14)	34.70 (1.54)	32.55 (1.45)

66. Secondary Outcome

Title	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	18.78 (1.27)	19.15 (1.36)	20.41 (1.35)	20.02 (1.31)	20.74 (0.93)	20.27 (0.88)
Week 12	19.68 (1.23)	19.52 (1.28)	20.41 (1.27)	21.18 (1.30)	19.26 (0.92)	20.01 (0.85)
End of treatment	20.29 (1.16)	19.29 (1.22)	20.71 (1.19)	20.47 (1.18)	20.29 (0.85)	20.36 (0.80)

67. Secondary Outcome

Title	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	22.34 (1.35)	23.86 (1.44)	25.12 (1.43)	24.28 (1.38)	21.48 (0.99)	21.80 (0.94)
Week 12	22.63 (1.42)	23.54 (1.47)	26.03 (1.46)	23.52 (1.50)	22.60 (1.05)	24.08 (0.98)
End of treatment	23.01 (1.31)	24.12 (1.37)	26.23 (1.34)	23.33 (1.33)	22.66 (0.96)	24.14 (0.90)

68. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	-0.71 (1.86)	0.14 (1.99)	-0.69 (1.98)	0.85 (1.91)	-1.61 (1.36)	0.41 (1.29)
Week 12	1.18 (1.98)	-2.45 (2.05)	-4.55 (2.03)	-1.63 (2.08)	0.68 (1.47)	0.62 (1.37)
End of treatment	1.15 (1.83)	-1.38 (1.91)	-2.30 (1.87)	-0.97 (1.85)	0.25 (1.33)	0.68 (1.26)

69. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	-0.76 (1.31)	-1.08 (1.40)	-0.20 (1.39)	-1.60 (1.34)	0.39 (0.96)	-0.56 (0.91)
Week 12	0.53 (1.30)	0.15 (1.34)	-1.90 (1.33)	-0.66 (1.36)	-1.24 (0.96)	0.46 (0.90)
End of treatment	0.87 (1.23)	0.27 (1.28)	-0.96 (1.26)	-1.67 (1.24)	-0.98 (0.89)	0.52 (0.85)

70. Secondary Outcome

Title	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Description	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Time Frame	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm/Group Title	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.	Participants who received mirabegron 25 mg once a day for 12 weeks.	Participants who received mirabegron 50 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Measure Participants	92	85	87	86	176	189
Week 4	1.16 (1.38)	0.46 (1.48)	1.54 (1.46)	0.78 (1.41)	-0.68 (1.01)	-0.51 (0.96)
Week 12	3.35 (1.45)	-0.04 (1.50)	1.15 (1.49)	3.49 (1.53)	-0.53 (1.07)	1.48 (1.00)
End of treatment	2.48 (1.32)	0.45 (1.37)	1.14 (1.35)	3.16 (1.33)	-0.02 (0.96)	1.80 (0.91)

Adverse Events

	Placebo		Mirabegron 25 mg		Mirabegron 50 mg		Solifenacin 5 mg		Solifenacin 5 mg + Mirabegron 25 mg		Solifenacin 5 mg + Mirabegron 50 mg
Time Frame	From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks).
Adverse Event Reporting Description

Arm/Group Title	Placebo		Mirabegron 25 mg		Mirabegron 50 mg		Solifenacin 5 mg		Solifenacin 5 mg + Mirabegron 25 mg		Solifenacin 5 mg + Mirabegron 50 mg
Arm/Group Description	Participants who received matching placebo once a day for 12 weeks.		Participants who received mirabegron 25 mg once a day for 12 weeks.		Participants who received mirabegron 50 mg once a day for 12 weeks.		Participants who received solifenacin 5 mg once a day for 12 weeks.		Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.		Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
All Cause Mortality
	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	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Serious Adverse Events
	Placebo		Mirabegron 25 mg		Mirabegron 50 mg		Solifenacin 5 mg		Solifenacin 5 mg + Mirabegron 25 mg		Solifenacin 5 mg + Mirabegron 50 mg
	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	8/429 (1.9%)		6/423 (1.4%)		5/422 (1.2%)		3/423 (0.7%)		12/853 (1.4%)		19/848 (2.2%)
Cardiac disorders
Cardiac failure	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		1/848 (0.1%)
Angina pectoris	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Atrial flutter	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Palpitations	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Supraventricular tachycardia	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Ear and labyrinth disorders
Otorrhoea	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic	0/429 (0%)		0/423 (0%)		0/422 (0%)		1/423 (0.2%)		0/853 (0%)		0/848 (0%)
Gastrointestinal haemorrhage	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Haemorrhoids	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Rectal haemorrhage	0/429 (0%)		0/423 (0%)		0/422 (0%)		1/423 (0.2%)		0/853 (0%)		0/848 (0%)
Hepatobiliary disorders
Cholecystitis	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Cholelithiasis	0/429 (0%)		0/423 (0%)		1/422 (0.2%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Hepatitis toxic	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Immune system disorders
Hypersensitivity	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Infections and infestations
Appendicitis	0/429 (0%)		0/423 (0%)		1/422 (0.2%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Bronchitis	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Bronchopneumonia	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Pneumonia	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Post procedural infection	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Pyelonephritis	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Pyelonephritis acute	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Scrub typhus	0/429 (0%)		0/423 (0%)		0/422 (0%)		1/423 (0.2%)		0/853 (0%)		0/848 (0%)
Septic shock	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Injury, poisoning and procedural complications
Hip fracture	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Laceration	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Ligament rupture	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Lower limb fracture	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Upper limb fracture	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Rotator cuff syndrome	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Spondylolisthesis	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/429 (0.2%)		0/423 (0%)		1/422 (0.2%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Benign neoplasm of thyroid gland	0/429 (0%)		0/423 (0%)		0/422 (0%)		1/423 (0.2%)		0/853 (0%)		0/848 (0%)
Plasma cell myeloma	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Squamous cell carcinoma	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Nervous system disorders
Transient ischaemic attack	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		1/848 (0.1%)
Cerebral haemorrhage	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Cerebrovascular disorder	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Grand mal convulsion	0/429 (0%)		0/423 (0%)		1/422 (0.2%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Hydrocephalus	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Radiculopathy	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Subarachnoid haemorrhage	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Psychiatric disorders
Depression	0/429 (0%)		1/423 (0.2%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Renal and urinary disorders
Renal colic	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Urinary retention	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Reproductive system and breast disorders
Menorrhagia	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Respiratory, thoracic and mediastinal disorders
Apnoea	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Chronic obstructive pulmonary disease	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		0/848 (0%)
Hiccups	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Skin and subcutaneous tissue disorders
Pruritus	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Surgical and medical procedures
Renal stone removal	1/429 (0.2%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Vascular disorders
Hypertensive crisis	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		1/853 (0.1%)		2/848 (0.2%)
Hypertension	0/429 (0%)		0/423 (0%)		0/422 (0%)		0/423 (0%)		0/853 (0%)		1/848 (0.1%)
Hypovolaemic shock	0/429 (0%)		0/423 (0%)		1/422 (0.2%)		0/423 (0%)		0/853 (0%)		0/848 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Mirabegron 25 mg		Mirabegron 50 mg		Solifenacin 5 mg		Solifenacin 5 mg + Mirabegron 25 mg		Solifenacin 5 mg + Mirabegron 50 mg
	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	8/429 (1.9%)		17/423 (4%)		14/422 (3.3%)		25/423 (5.9%)		72/853 (8.4%)		60/848 (7.1%)
Gastrointestinal disorders
Dry mouth	8/429 (1.9%)		17/423 (4%)		14/422 (3.3%)		25/423 (5.9%)		72/853 (8.4%)		60/848 (7.1%)

Limitations/Caveats

Due to lack of data integrity, one site's data was not included in the efficacy and safety analysis.

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 at least 45 days prior to publication for review and comment. Sponsor may delay the publication temporarily to seek patent protection or permanently withhold the publication.

Results Point of Contact

Name/Title	Medical Director
Organization	Astellas Pharma Europe B.V.
Phone	+31 (0) 71 5455 050
Email	astellas.resultsdisclosure@astellas.com

Responsible Party:

Astellas Pharma Europe B.V.

ClinicalTrials.gov Identifier:

NCT01972841

Other Study ID Numbers:

178-CL-101
2012-005735-91
U1111-1153-9095

First Posted:

Oct 31, 2013

Last Update Posted:

Nov 1, 2018

Last Verified:

Oct 1, 2018