Trial Outcomes & Findings for A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder (NCT NCT02045862)

NCT ID: NCT02045862

Last Updated: 2024-10-31

Results Overview

A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1829 participants

Primary outcome timeframe

From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)

Results posted on

2024-10-31

Participant Flow

Participants who had symptoms of "wet" overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 251 centers globally. A majority of the participants were recruited from participants who enrolled and completed studies 178-CL-101 (NCT01972841) or 905-EC-012 (NCT01908829).

A total of 2084 participants were screened, 2063 participants received placebo run-in treatment and 1829 participants were randomized into 1 of 3 treatment arms in a 1:1:4 ratio in the 52-week double-blind treatment period. Randomization was stratified by sex, age group (\< 65 years, ≥ 65 years) and geographic region.

Participant milestones

Participant milestones
Measure	Mirabegron 50 mg Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Study STARTED	306	305	1218
Overall Study Treated	306	303	1210
Overall Study COMPLETED	267	265	1092
Overall Study NOT COMPLETED	39	40	126

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirabegron 50 mg Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Study Death	0	0	1
Overall Study Miscellaneous	5	0	8
Overall Study Withdrawal by Patient	18	27	57
Overall Study Protocol Violation	0	0	6
Overall Study Lack of Efficacy	8	4	13
Overall Study Randomized but not Received Study Drug	0	2	8
Overall Study Adverse Event	7	5	27
Overall Study Lost to Follow-up	1	2	6

Baseline Characteristics

Full analysis set (FAS), which consisted of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirabegron 50 mg n=306 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=305 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1218 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.	Total n=1829 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 12.7 • n=306 Participants	59.0 years STANDARD_DEVIATION 13.3 • n=305 Participants	58.3 years STANDARD_DEVIATION 13.0 • n=1218 Participants	58.5 years STANDARD_DEVIATION 13.0 • n=1829 Participants
Sex: Female, Male Female	243 Participants n=306 Participants	245 Participants n=305 Participants	973 Participants n=1218 Participants	1461 Participants n=1829 Participants
Sex: Female, Male Male	63 Participants n=306 Participants	60 Participants n=305 Participants	245 Participants n=1218 Participants	368 Participants n=1829 Participants
Race/Ethnicity, Customized White	266 Participants n=306 Participants	265 Participants n=305 Participants	1066 Participants n=1218 Participants	1597 Participants n=1829 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=306 Participants	4 Participants n=305 Participants	27 Participants n=1218 Participants	36 Participants n=1829 Participants
Race/Ethnicity, Customized Asian	31 Participants n=306 Participants	33 Participants n=305 Participants	119 Participants n=1218 Participants	183 Participants n=1829 Participants
Race/Ethnicity, Customized Other	4 Participants n=306 Participants	3 Participants n=305 Participants	6 Participants n=1218 Participants	13 Participants n=1829 Participants
Race/Ethnicity, Customized Hispanic or Latino	15 Participants n=306 Participants	15 Participants n=305 Participants	54 Participants n=1218 Participants	84 Participants n=1829 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	291 Participants n=306 Participants	290 Participants n=305 Participants	1164 Participants n=1218 Participants	1745 Participants n=1829 Participants
Mean Number of Incontinence Episodes per 24 Hours	3.15 incontinence episodes/24 hours STANDARD_DEVIATION 3.56 • n=302 Participants • Full analysis set (FAS), which consisted of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues.	3.10 incontinence episodes/24 hours STANDARD_DEVIATION 3.58 • n=299 Participants • Full analysis set (FAS), which consisted of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues.	3.04 incontinence episodes/24 hours STANDARD_DEVIATION 3.17 • n=1193 Participants • Full analysis set (FAS), which consisted of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues.	3.07 incontinence episodes/24 hours STANDARD_DEVIATION 3.31 • n=1794 Participants • Full analysis set (FAS), which consisted of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues.
Mean Number of Micturitions per 24 Hours	10.51 micturitions/24 hours STANDARD_DEVIATION 2.41 • n=302 Participants • FAS population	10.76 micturitions/24 hours STANDARD_DEVIATION 2.83 • n=299 Participants • FAS population	10.55 micturitions/24 hours STANDARD_DEVIATION 2.73 • n=1193 Participants • FAS population	10.58 micturitions/24 hours STANDARD_DEVIATION 2.70 • n=1794 Participants • FAS population
Mean Volume Voided per Micturition	161.00 mL STANDARD_DEVIATION 60.16 • n=302 Participants • FAS population with available data at baseline	160.70 mL STANDARD_DEVIATION 58.49 • n=299 Participants • FAS population with available data at baseline	159.29 mL STANDARD_DEVIATION 58.40 • n=1190 Participants • FAS population with available data at baseline	159.82 mL STANDARD_DEVIATION 58.69 • n=1791 Participants • FAS population with available data at baseline
Number of Incontinence Episodes per Week	21.8 incontinence episodes/week STANDARD_DEVIATION 24.8 • n=302 Participants • FAS population	21.6 incontinence episodes/week STANDARD_DEVIATION 25.0 • n=299 Participants • FAS population	20.9 incontinence episodes/week STANDARD_DEVIATION 21.9 • n=1193 Participants • FAS population	21.2 incontinence episodes/week STANDARD_DEVIATION 22.9 • n=1794 Participants • FAS population
Mean Number of Urgency Incontinence Episodes per 24 Hours	2.86 urgency incontinence episodes/24 hours STANDARD_DEVIATION 3.29 • n=302 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline	2.91 urgency incontinence episodes/24 hours STANDARD_DEVIATION 3.49 • n=297 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline	2.74 urgency incontinence episodes/24 hours STANDARD_DEVIATION 2.78 • n=1187 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline	2.79 urgency incontinence episodes/24 hours STANDARD_DEVIATION 3.00 • n=1786 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline
Number of Urgency Incontinence Episodes per Week	19.8 urgency incontinence episodes/week STANDARD_DEVIATION 22.8 • n=302 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline	20.2 urgency incontinence episodes/week STANDARD_DEVIATION 24.5 • n=297 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline	18.9 urgency incontinence episodes/week STANDARD_DEVIATION 19.1 • n=1187 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline	19.3 urgency incontinence episodes/week STANDARD_DEVIATION 20.7 • n=1786 Participants • FAS population with ≥ 1 urgency incontinence episode at baseline
Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours	6.34 urgency episodes/24 hours STANDARD_DEVIATION 4.16 • n=302 Participants • FAS population with ≥ 1 urgency episode at baseline	6.63 urgency episodes/24 hours STANDARD_DEVIATION 4.08 • n=299 Participants • FAS population with ≥ 1 urgency episode at baseline	6.53 urgency episodes/24 hours STANDARD_DEVIATION 3.69 • n=1193 Participants • FAS population with ≥ 1 urgency episode at baseline	6.51 urgency episodes/24 hours STANDARD_DEVIATION 3.84 • n=1794 Participants • FAS population with ≥ 1 urgency episode at baseline
Mean Number of Nocturia Episodes per 24 Hours	1.48 nocturia episodes/24 hours STANDARD_DEVIATION 0.95 • n=262 Participants • FAS population with ≥ 1 nocturia episode at baseline	1.58 nocturia episodes/24 hours STANDARD_DEVIATION 0.94 • n=252 Participants • FAS population with ≥ 1 nocturia episode at baseline	1.49 nocturia episodes/24 hours STANDARD_DEVIATION 0.94 • n=1027 Participants • FAS population with ≥ 1 nocturia episode at baseline	1.51 nocturia episodes/24 hours STANDARD_DEVIATION 0.94 • n=1541 Participants • FAS population with ≥ 1 nocturia episode at baseline
Number of Nocturia Episodes per Week	10.3 nocturia episodes/week STANDARD_DEVIATION 6.6 • n=262 Participants • FAS population with ≥ 1 nocturia episode at baseline	11.0 nocturia episodes/week STANDARD_DEVIATION 6.6 • n=252 Participants • FAS population with ≥ 1 nocturia episode at baseline	10.4 nocturia episodes/week STANDARD_DEVIATION 6.5 • n=1027 Participants • FAS population with ≥ 1 nocturia episode at baseline	10.4 nocturia episodes/week STANDARD_DEVIATION 6.5 • n=1541 Participants • FAS population with ≥ 1 nocturia episode at baseline
Mean Number of Pads Used per 24 Hours	2.51 pads/24 hours STANDARD_DEVIATION 3.76 • n=201 Participants • FAS population with ≥ 1 pad used at baseline	2.77 pads/24 hours STANDARD_DEVIATION 3.15 • n=193 Participants • FAS population with ≥ 1 pad used at baseline	2.58 pads/24 hours STANDARD_DEVIATION 2.59 • n=771 Participants • FAS population with ≥ 1 pad used at baseline	2.60 pads/24 hours STANDARD_DEVIATION 2.91 • n=1165 Participants • FAS population with ≥ 1 pad used at baseline
Number of Pads Used per Week	17.3 pads/week STANDARD_DEVIATION 26.1 • n=201 Participants • FAS population with ≥ 1 pad used at baseline	19.2 pads/week STANDARD_DEVIATION 22.0 • n=193 Participants • FAS population with ≥ 1 pad used at baseline	17.7 pads/week STANDARD_DEVIATION 17.6 • n=771 Participants • FAS population with ≥ 1 pad used at baseline	17.9 pads/week STANDARD_DEVIATION 20.0 • n=1165 Participants • FAS population with ≥ 1 pad used at baseline

PRIMARY outcome

Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)

Population: The analysis population was the safety analysis set (SAF), which consisted of all participants who received ≥ 1 dose of double-blind study drug and excluded participants from one site due to protocol noncompliance.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=305 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=303 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1206 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAEs	126 Participants	134 Participants	596 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Mild TEAEs	61 Participants	69 Participants	306 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Moderate TEAEs	52 Participants	58 Participants	238 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Severe TEAEs	13 Participants	7 Participants	52 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Drug-related TEAEs	35 Participants	42 Participants	200 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Serious TEAEs	8 Participants	8 Participants	51 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Drug-related Serious TEAEs	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs Leading to Discontuation of Study Drug	7 Participants	5 Participants	25 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Drug-related TEAEs Leading to Discont. of Drug	4 Participants	4 Participants	17 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs Leading to Death	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: FAS population; Last observation carried forward (LOCF) was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=301 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=297 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1184 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.58 incontinence episodes Standard Error 0.11	-1.90 incontinence episodes Standard Error 0.11	-2.03 incontinence episodes Standard Error 0.05

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: FAS population; LOCF was used for EoT.

A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=301 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=297 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1184 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.10 micturitions Standard Error 0.13	-2.16 micturitions Standard Error 0.13	-2.58 micturitions Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.

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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=289 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=293 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1162 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to EoT in Mean Volume Voided Per Micturition	21.83 mL Standard Error 3.12	24.90 mL Standard Error 3.10	37.67 mL Standard Error 1.55

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=290 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=294 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1163 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-21.96 units on a scale Standard Error 1.14	-24.91 units on a scale Standard Error 1.13	-29.51 units on a scale Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.

The TS-VAS is a visual analogue scale which asks 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=289 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=294 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1163 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.19 units on a scale Standard Error 0.12	2.15 units on a scale Standard Error 0.12	2.73 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours Month 1	-0.97 incontinence episodes Standard Error 0.10	-1.29 incontinence episodes Standard Error 0.11	-1.45 incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours Month 3	-1.31 incontinence episodes Standard Error 0.11	-1.71 incontinence episodes Standard Error 0.11	-1.78 incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours Month 6	-1.42 incontinence episodes Standard Error 0.11	-1.78 incontinence episodes Standard Error 0.11	-1.93 incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours Month 9	-1.53 incontinence episodes Standard Error 0.11	-1.90 incontinence episodes Standard Error 0.11	-2.00 incontinence episodes Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours Month 12	-1.67 incontinence episodes Standard Error 0.11	-1.92 incontinence episodes Standard Error 0.11	-2.06 incontinence episodes Standard Error 0.06

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	14.88 incontinence episodes Standard Error 1.52	12.41 incontinence episodes Standard Error 1.22	10.80 incontinence episodes Standard Error 0.58
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	12.23 incontinence episodes Standard Error 1.12	9.23 incontinence episodes Standard Error 1.02	8.33 incontinence episodes Standard Error 0.52
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	10.62 incontinence episodes Standard Error 1.08	8.18 incontinence episodes Standard Error 1.01	7.28 incontinence episodes Standard Error 0.48
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	10.53 incontinence episodes Standard Error 1.19	7.28 incontinence episodes Standard Error 0.91	6.74 incontinence episodes Standard Error 0.45
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	9.09 incontinence episodes Standard Error 1.10	7.06 incontinence episodes Standard Error 0.94	6.10 incontinence episodes Standard Error 0.46
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit EoT	10.32 incontinence episodes Standard Error 1.08	8.09 incontinence episodes Standard Error 0.94	6.85 incontinence episodes Standard Error 0.47

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	-6.77 incontinence episodes Standard Error 0.73	-9.17 incontinence episodes Standard Error 0.73	-10.31 incontinence episodes Standard Error 0.36
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	-9.21 incontinence episodes Standard Error 0.76	-12.05 incontinence episodes Standard Error 0.75	-12.55 incontinence episodes Standard Error 0.38
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	-10.36 incontinence episodes Standard Error 0.76	-12.50 incontinence episodes Standard Error 0.75	-13.49 incontinence episodes Standard Error 0.37
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	-10.62 incontinence episodes Standard Error 0.76	-13.51 incontinence episodes Standard Error 0.77	-14.06 incontinence episodes Standard Error 0.38
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	-11.84 incontinence episodes Standard Error 0.77	-13.47 incontinence episodes Standard Error 0.77	-14.43 incontinence episodes Standard Error 0.38
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit EoT	-11.17 incontinence episodes Standard Error 0.75	-13.37 incontinence episodes Standard Error 0.75	-14.29 incontinence episodes Standard Error 0.37

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

Population: FAS population with with data available at each time point; LOCF was used for EoT.

The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	3.97 incontinence-free days Standard Error 0.18	4.33 incontinence-free days Standard Error 0.17	4.56 incontinence-free days Standard Error 0.08
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	2.73 incontinence-free days Standard Error 0.15	3.35 incontinence-free days Standard Error 0.17	3.46 incontinence-free days Standard Error 0.08
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	3.30 incontinence-free days Standard Error 0.17	3.98 incontinence-free days Standard Error 0.17	4.17 incontinence-free days Standard Error 0.08
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	3.64 incontinence-free days Standard Error 0.17	4.08 incontinence-free days Standard Error 0.17	4.44 incontinence-free days Standard Error 0.08
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	4.23 incontinence-free days Standard Error 0.18	4.5 incontinence-free days Standard Error 0.18	4.81 incontinence-free days Standard Error 0.08
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit EoT	3.98 incontinence-free days Standard Error 0.17	4.29 incontinence-free days Standard Error 0.16	4.64 incontinence-free days Standard Error 0.08

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	1.56 days Standard Error 0.14	1.66 days Standard Error 0.14	2.13 days Standard Error 0.08
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	1.56 days Standard Error 0.14	1.64 days Standard Error 0.14	2.20 days Standard Error 0.08
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit EoT	1.75 days Standard Error 0.14	1.90 days Standard Error 0.14	2.43 days Standard Error 0.07
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	1.03 days Standard Error 0.10	1.01 days Standard Error 0.10	1.33 days Standard Error 0.06
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	1.24 days Standard Error 0.12	1.48 days Standard Error 0.13	1.91 days Standard Error 0.07
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	1.87 days Standard Error 0.15	1.92 days Standard Error 0.15	2.54 days Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

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

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=297 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1187 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours Month 1	-0.93 urgency incontinence episodes Standard Error 0.10	-1.25 urgency incontinence episodes Standard Error 0.10	-1.43 urgency incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours Month 3	-1.30 urgency incontinence episodes Standard Error 0.10	-1.64 urgency incontinence episodes Standard Error 0.10	-1.71 urgency incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours Month 6	-1.40 urgency incontinence episodes Standard Error 0.10	-1.67 urgency incontinence episodes Standard Error 0.10	-1.86 urgency incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours Month 9	-1.60 urgency incontinence episodes Standard Error 0.11	-1.78 urgency incontinence episodes Standard Error 0.11	-1.92 urgency incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours Month 12	-1.60 urgency incontinence episodes Standard Error 0.10	-1.82 urgency incontinence episodes Standard Error 0.10	-1.98 urgency incontinence episodes Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours EoT	-1.51 urgency incontinence episodes Standard Error 0.10	-1.81 urgency incontinence episodes Standard Error 0.10	-1.94 urgency incontinence episodes Standard Error 0.05

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

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

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=297 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1187 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	10.37 urgency incontinence episodes Standard Error 1.00	8.12 urgency incontinence episodes Standard Error 0.98	6.95 urgency incontinence episodes Standard Error 0.44
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	8.97 urgency incontinence episodes Standard Error 0.95	7.31 urgency incontinence episodes Standard Error 0.96	5.88 urgency incontinence episodes Standard Error 0.41
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	8.08 urgency incontinence episodes Standard Error 1.01	6.51 urgency incontinence episodes Standard Error 0.89	5.47 urgency incontinence episodes Standard Error 0.40
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	7.73 urgency incontinence episodes Standard Error 1.00	6.06 urgency incontinence episodes Standard Error 0.85	4.88 urgency incontinence episodes Standard Error 0.38
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	13.14 urgency incontinence episodes Standard Error 1.42	11.21 urgency incontinence episodes Standard Error 1.19	8.99 urgency incontinence episodes Standard Error 0.47
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit EoT	8.86 urgency incontinence episodes Standard Error 0.98	7.04 urgency incontinence episodes Standard Error 0.86	5.57 urgency incontinence episodes Standard Error 0.40

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

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

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 total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	-6.45 urgency incontinence episodes Standard Error 0.69	-8.77 urgency incontinence episodes Standard Error 0.69	-10.1 urgency incontinence episodes Standard Error 0.34
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	-9.06 urgency incontinence episodes Standard Error 0.72	-11.48 urgency incontinence episodes Standard Error 0.71	-11.99 urgency incontinence episodes Standard Error 0.36
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	-10.09 urgency incontinence episodes Standard Error 0.72	-11.71 urgency incontinence episodes Standard Error 0.71	-13.0 urgency incontinence episodes Standard Error 0.35
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	-11.1 urgency incontinence episodes Standard Error 0.72	-12.6 urgency incontinence episodes Standard Error 0.73	-13.44 urgency incontinence episodes Standard Error 0.36
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	-11.27 urgency incontinence episodes Standard Error 0.71	-12.8 urgency incontinence episodes Standard Error 0.71	-13.8 urgency incontinence episodes Standard Error 0.35
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit EoT	-10.61 urgency incontinence episodes Standard Error 0.7	12.66 urgency incontinence episodes Standard Error 0.7	-13.59 urgency incontinence episodes Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours Month 1	-1.09 micturitions Standard Error 0.12	-1.36 micturitions Standard Error 0.12	-1.64 micturitions Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours Month 3	-1.63 micturitions Standard Error 0.13	-1.87 micturitions Standard Error 0.12	2.16 micturitions Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours Month 6	-1.85 micturitions Standard Error 0.13	-2.04 micturitions Standard Error 0.13	-2.39 micturitions Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours Month 9	-2.03 micturitions Standard Error 0.13	-2.03 micturitions Standard Error 0.13	-2.42 micturitions Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours Month 12	-2.20 micturitions Standard Error 0.13	-2.13 micturitions Standard Error 0.14	-2.64 micturitions Standard Error 0.07

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) Month 1	1.90 days Standard Error 0.13	1.60 days Standard Error 0.12	2.08 days Standard Error 0.07
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) Month 3	2.07 days Standard Error 0.14	2.14 days Standard Error 0.14	2.66 days Standard Error 0.08
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) Month 6	2.35 days Standard Error 0.15	2.34 days Standard Error 0.15	2.87 days Standard Error 0.08
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) Month 9	2.38 days Standard Error 0.16	2.33 days Standard Error 0.15	2.93 days Standard Error 0.08
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) Month 12	2.61 days Standard Error 0.16	2.58 days Standard Error 0.16	3.17 days Standard Error 0.08
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) EoT	2.52 days Standard Error 0.15	2.58 days Standard Error 0.15	3.10 days Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

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. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=301 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=297 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1184 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to EoT in Corrected Micturition Frequency	-0.72 micturitions Standard Error 0.17	-1.11 micturitions Standard Error 0.17	-1.51 micturitions Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, 12

Population: FAS population with data available at each time point.

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 prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition Month 6	20.87 mL Standard Error 3.21	27.08 mL Standard Error 3.19	38.56 mL Standard Error 1.57
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition Month 3	15.34 mL Standard Error 2.96	23.71 mL Standard Error 2.92	34.89 mL Standard Error 1.45
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition Month 12	21.85 mL Standard Error 3.42	24.05 mL Standard Error 3.37	38.72 mL Standard Error 1.67

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. Participants with ≥ 1 urgency episode at baseline were included in the analysis. LOCF was used for EoT.

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Month 1	-1.93 urgency episodes Standard Error 0.17	-2.31 urgency episodes Standard Error 0.17	-2.68 urgency episodes Standard Error 0.09
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Month 3	-2.68 urgency episodes Standard Error 0.17	-3.02 urgency episodes Standard Error 0.17	-3.36 urgency episodes Standard Error 0.08
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Month 6	-2.93 urgency episodes Standard Error 0.17	-3.17 urgency episodes Standard Error 0.17	-3.72 urgency episodes Standard Error 0.08
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Month 9	-3.40 urgency episodes Standard Error 0.18	-3.55 urgency episodes Standard Error 0.18	-3.87 urgency episodes Standard Error 0.09
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Month 12	-3.40 urgency episodes Standard Error 0.17	-3.56 urgency episodes Standard Error 0.17	-3.95 urgency episodes Standard Error 0.09
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours EoT	-3.11 urgency episodes Standard Error 0.17	-3.45 urgency episodes Standard Error 0.17	-3.84 urgency episodes Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

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

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 goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=262 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=252 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1027 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours Month 1	-0.20 nocturia episodes Standard Error 0.04	-0.22 nocturia episodes Standard Error 0.04	-0.34 nocturia episodes Standard Error 0.02
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours Month 3	-0.34 nocturia episodes Standard Error 0.04	-0.38 nocturia episodes Standard Error 0.04	-0.46 nocturia episodes Standard Error 0.02
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours Month 6	-0.41 nocturia episodes Standard Error 0.05	-0.39 nocturia episodes Standard Error 0.05	-0.49 nocturia episodes Standard Error 0.02
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours Month 9	-0.42 nocturia episodes Standard Error 0.05	-0.44 nocturia episodes Standard Error 0.05	-0.50 nocturia episodes Standard Error 0.02
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours Month 12	-0.46 nocturia episodes Standard Error 0.05	-0.44 nocturia episodes Standard Error 0.05	-0.56 nocturia episodes Standard Error 0.02
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours EoT	-0.45 nocturia episodes Standard Error 0.04	-0.45 nocturia episodes Standard Error 0.04	-0.55 nocturia episodes Standard Error 0.02

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

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

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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=262 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=252 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1027 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	7.12 nocturia episodes Standard Error 0.35	7.86 nocturia episodes Standard Error 0.43	6.96 nocturia episodes Standard Error 0.20
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	8.76 nocturia episodes Standard Error 0.41	9.23 nocturia episodes Standard Error 0.44	8.00 nocturia episodes Standard Error 0.20
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	7.93 nocturia episodes Standard Error 0.39	7.92 nocturia episodes Standard Error 0.40	7.17 nocturia episodes Standard Error 0.19
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	7.40 nocturia episodes Standard Error 0.38	7.48 nocturia episodes Standard Error 0.41	6.84 nocturia episodes Standard Error 0.20
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	6.88 nocturia episodes Standard Error 0.38	7.39 nocturia episodes Standard Error 0.44	6.33 nocturia episodes Standard Error 0.19
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit EoT	7.13 nocturia episodes Standard Error 0.37	7.47 nocturia episodes Standard Error 0.42	6.51 nocturia episodes Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

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

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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=262 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=252 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1027 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	-1.56 nocturia episodes Standard Error 0.29	-1.58 nocturia episodes Standard Error 0.29	-2.39 nocturia episodes Standard Error 0.15
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	-2.45 nocturia episodes Standard Error 0.29	-2.78 nocturia episodes Standard Error 0.30	-3.26 nocturia episodes Standard Error 0.15
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	-3.08 nocturia episodes Standard Error 0.33	-2.81 nocturia episodes Standard Error 0.33	-3.44 nocturia episodes Standard Error 0.16
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	-2.91 nocturia episodes Standard Error 0.32	-3.13 nocturia episodes Standard Error 0.32	-3.55 nocturia episodes Standard Error 0.16
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	-3.29 nocturia episodes Standard Error 0.32	-3.08 nocturia episodes Standard Error 0.33	-3.97 nocturia episodes Standard Error 0.16
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit EoT	-3.24 nocturia episodes Standard Error 0.31	-3.20 nocturia episodes Standard Error 0.32	-3.90 nocturia episodes Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

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

The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=201 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=193 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=771 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours Month 1	-0.67 pads Standard Error 0.10	-0.96 pads Standard Error 0.11	-1.25 pads Standard Error 0.05
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours Month 3	-1.12 pads Standard Error 0.11	-1.30 pads Standard Error 0.11	-1.49 pads Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours Month 6	-1.30 pads Standard Error 0.12	-1.24 pads Standard Error 0.12	-1.59 pads Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours Month 9	-1.38 pads Standard Error 0.12	-1.31 pads Standard Error 0.13	-1.65 pads Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours Month 12	-1.35 pads Standard Error 0.12	-1.37 pads Standard Error 0.13	-1.67 pads Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours EoT	-1.23 pads Standard Error 0.12	-1.38 pads Standard Error 0.12	-1.66 pads Standard Error 0.06

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

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

The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=201 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=193 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=771 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	12.67 pads Standard Error 1.98	12.55 pads Standard Error 1.59	8.75 pads Standard Error 0.50
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	9.61 pads Standard Error 1.12	9.47 pads Standard Error 1.28	7.23 pads Standard Error 0.5
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	7.99 pads Standard Error 1.03	9.16 pads Standard Error 1.28	6.51 pads Standard Error 0.47
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	7.65 pads Standard Error 1.08	8.91 pads Standard Error 1.28	6.18 pads Standard Error 0.46
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	7.60 pads Standard Error 1.05	8.09 pads Standard Error 1.23	5.70 pads Standard Error 0.44
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit EoT	9.09 pads Standard Error 1.07	8.54 pads Standard Error 1.10	6.33 pads Standard Error 0.45

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

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

The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=201 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=193 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=771 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 12	-9.39 pads Standard Error 0.85	-9.92 pads Standard Error 0.87	-11.66 pads Standard Error 0.42
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 1	-4.74 pads Standard Error 0.71	-6.72 pads Standard Error 0.72	-8.89 pads Standard Error 0.36
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 3	-7.83 pads Standard Error 0.77	-9.21 pads Standard Error 0.78	10.47 pads Standard Error 0.39
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 6	-9.09 pads Standard Error 0.85	-8.86 pads Standard Error 0.85	-11.12 pads Standard Error 0.42
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Month 9	-9.59 pads Standard Error 0.87	-9.33 pads Standard Error 0.89	-11.44 pads Standard Error 0.43
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit EoT	-8.59 pads Standard Error 0.82	-9.89 pads Standard Error 0.84	-11.58 pads Standard Error 0.42

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score Month 1	-16.37 units on a scale Standard Error 1.08	-20.82 units on a scale Standard Error 1.07	-22.86 units on a scale Standard Error 0.54
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score Month 3	-19.69 units on a scale Standard Error 1.08	-23.13 units on a scale Standard Error 1.07	-26.88 units on a scale Standard Error 0.53
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score Month 6	-20.97 units on a scale Standard Error 1.14	-24.27 units on a scale Standard Error 1.12	-27.73 units on a scale Standard Error 0.55
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score Month 9	-21.41 units on a scale Standard Error 1.15	-25.82 units on a scale Standard Error 1.14	-28.45 units on a scale Standard Error 0.56
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score Month 12	-23.41 units on a scale Standard Error 1.19	-25.38 units on a scale Standard Error 1.18	-30.18 units on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score Month 1	11.67 units on a scale Standard Error 0.92	14.01 units on a scale Standard Error 0.91	15.69 units on a scale Standard Error 0.45
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score Month 3	15.25 units on a scale Standard Error 0.95	16.41 units on a scale Standard Error 0.94	19.26 units on a scale Standard Error 0.47
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score Month 6	16.63 units on a scale Standard Error 1.02	17.96 units on a scale Standard Error 1.00	20.03 units on a scale Standard Error 0.49
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score Month 9	16.69 units on a scale Standard Error 1.02	18.53 units on a scale Standard Error 1.01	20.75 units on a scale Standard Error 0.50
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score Month 12	17.33 units on a scale Standard Error 1.04	18.80 units on a scale Standard Error 1.03	21.82 units on a scale Standard Error 0.51
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score EoT	16.57 units on a scale Standard Error 1.00	18.47 units on a scale Standard Error 0.99	21.33 units on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping Month 1	13.05 units on a scale Standard Error 1.09	15.40 units on a scale Standard Error 1.08	17.58 units on a scale Standard Error 0.54
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping Month 3	17.57 units on a scale Standard Error 1.14	18.38 units on a scale Standard Error 1.13	21.64 units on a scale Standard Error 0.56
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping Month 6	19.68 units on a scale Standard Error 1.22	20.53 units on a scale Standard Error 1.19	22.73 units on a scale Standard Error 0.59
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping Month 9	19.54 units on a scale Standard Error 1.21	21.21 units on a scale Standard Error 1.20	23.58 units on a scale Standard Error 0.59
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping Month 12	19.47 units on a scale Standard Error 1.25	21.90 units on a scale Standard Error 1.23	24.86 units on a scale Standard Error 0.61
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping EoT	18.54 units on a scale Standard Error 1.19	21.13 units on a scale Standard Error 1.18	24.14 units on a scale Standard Error 0.59

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern Month 1	13.24 units on a scale Standard Error 1.03	15.49 units on a scale Standard Error 1.02	17.60 units on a scale Standard Error 0.51
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern Month 3	16.37 units on a scale Standard Error 1.05	17.64 units on a scale Standard Error 1.04	21.23 units on a scale Standard Error 0.52
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern Month 6	17.77 units on a scale Standard Error 1.10	19.05 units on a scale Standard Error 1.07	21.73 units on a scale Standard Error 0.53
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern Month 9	18.15 units on a scale Standard Error 1.11	19.74 units on a scale Standard Error 1.10	22.30 units on a scale Standard Error 0.54
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern Month 12	19.10 units on a scale Standard Error 1.12	19.40 units on a scale Standard Error 1.10	23.30 units on a scale Standard Error 0.54
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern EoT	17.98 units on a scale Standard Error 1.08	19.22 units on a scale Standard Error 1.07	23.00 units on a scale Standard Error 0.54

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep Month 1	10.96 units on a scale Standard Error 1.08	14.24 units on a scale Standard Error 1.07	15.82 units on a scale Standard Error 0.54
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep Month 3	14.09 units on a scale Standard Error 1.12	16.71 units on a scale Standard Error 1.10	19.75 units on a scale Standard Error 0.55
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep Month 6	14.84 units on a scale Standard Error 1.22	17.70 units on a scale Standard Error 1.19	20.09 units on a scale Standard Error 0.59
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep Month 9	14.86 units on a scale Standard Error 1.22	17.73 units on a scale Standard Error 1.21	21.15 units on a scale Standard Error 0.60
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep Month 12	16.53 units on a scale Standard Error 1.29	18.28 units on a scale Standard Error 1.27	22.17 units on a scale Standard Error 0.63
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep EoT	16.44 units on a scale Standard Error 1.22	18.32 units on a scale Standard Error 1.21	21.59 units on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social Month 1	7.99 units on a scale Standard Error 0.84	9.41 units on a scale Standard Error 0.83	9.89 units on a scale Standard Error 0.42
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social Month 3	11.14 units on a scale Standard Error 0.85	11.19 units on a scale Standard Error 0.84	12.22 units on a scale Standard Error 0.42
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social Month 6	11.89 units on a scale Standard Error 0.89	12.54 units on a scale Standard Error 0.87	13.30 units on a scale Standard Error 0.43
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social Month 9	11.92 units on a scale Standard Error 0.90	13.33 units on a scale Standard Error 0.89	13.64 units on a scale Standard Error 0.44
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social Month 12	12.25 units on a scale Standard Error 0.90	13.47 units on a scale Standard Error 0.89	14.52 units on a scale Standard Error 0.44
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social EoT	11.57 units on a scale Standard Error 0.87	13.22 units on a scale Standard Error 0.87	14.25 units on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS Month 1	1.88 units on a scale Standard Error 0.12	1.95 units on a scale Standard Error 0.12	2.27 units on a scale Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS Month 3	2.10 units on a scale Standard Error 0.11	2.06 units on a scale Standard Error 0.11	2.57 units on a scale Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS Month 6	2.22 units on a scale Standard Error 0.12	2.25 units on a scale Standard Error 0.12	2.72 units on a scale Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS Month 9	2.24 units on a scale Standard Error 0.12	2.28 units on a scale Standard Error 0.12	2.74 units on a scale Standard Error 0.06
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS Month 12	2.33 units on a scale Standard Error 0.12	2.34 units on a scale Standard Error 0.12	2.89 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The PPBC is 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) Month 1	-0.84 units on a scale Standard Error 0.07	-0.89 units on a scale Standard Error 0.07	-1.05 units on a scale Standard Error 0.03
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) Month 3	-1.09 units on a scale Standard Error 0.07	-1.08 units on a scale Standard Error 0.07	-1.33 units on a scale Standard Error 0.03
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) Month 6	-1.11 units on a scale Standard Error 0.07	-1.18 units on a scale Standard Error 0.07	-1.42 units on a scale Standard Error 0.04
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) Month 9	-1.25 units on a scale Standard Error 0.07	-1.31 units on a scale Standard Error 0.07	-1.48 units on a scale Standard Error 0.04
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) Month 12	-1.29 units on a scale Standard Error 0.08	-1.36 units on a scale Standard Error 0.07	-1.59 units on a scale Standard Error 0.04
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) EoT	-1.22 units on a scale Standard Error 0.07	-1.34 units on a scale Standard Error 0.07	-1.54 units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Month 12

Population: FAS population with data available. LOCF was used for EoT.

The PGIC is 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).

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: Very much worse	0.3 percentage of participants	0.3 percentage of participants	0.5 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: Very much improved	25.5 percentage of participants	23.4 percentage of participants	33.8 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: Much improved	30.5 percentage of participants	35.8 percentage of participants	34.0 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: Minimally improved	21.9 percentage of participants	19.7 percentage of participants	16.1 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: No change	5.0 percentage of participants	6.4 percentage of participants	4.5 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: Minimally worse	0.7 percentage of participants	0.7 percentage of participants	0.4 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12: Much worse	1.0 percentage of participants	0.3 percentage of participants	0.1 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: Very much improved	25.8 percentage of participants	24.4 percentage of participants	34.1 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: Much improved	31.5 percentage of participants	37.1 percentage of participants	34.7 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: Minimally improved	22.2 percentage of participants	20.4 percentage of participants	16.6 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: No change	6.3 percentage of participants	7.0 percentage of participants	5.1 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: Minimally worse	0.7 percentage of participants	0.7 percentage of participants	0.4 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: Much worse	1.3 percentage of participants	0.7 percentage of participants	0.1 percentage of participants
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT EoT: Very much worse	0.3 percentage of participants	0.3 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: FAS population with data available. LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: Very much improved	12.9 percentage of participants	14.7 percentage of participants	18.0 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: Much improved	23.8 percentage of participants	26.8 percentage of participants	28.7 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: Minimally improved	18.9 percentage of participants	17.1 percentage of participants	18.7 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: No change	24.2 percentage of participants	24.7 percentage of participants	20.7 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: Minimally worse	3.6 percentage of participants	2.7 percentage of participants	2.7 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: Much worse	0.7 percentage of participants	0 percentage of participants	0.4 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12: Very much worse	0.7 percentage of participants	0.7 percentage of participants	0.3 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: Very much improved	13.2 percentage of participants	15.1 percentage of participants	18.3 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: Much improved	24.5 percentage of participants	27.8 percentage of participants	28.9 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: Minimally improved	19.2 percentage of participants	18.1 percentage of participants	19.1 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: No change	25.8 percentage of participants	25.8 percentage of participants	21.6 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: Minimally worse	3.6 percentage of participants	3.0 percentage of participants	2.8 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: Much worse	1.0 percentage of participants	0.3 percentage of participants	0.5 percentage of participants
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT EoT: Very much worse	0.7 percentage of participants	0.7 percentage of participants	0.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: FAS population; LOCF was used for EoT.

The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Slight problems -> no problems	19 Participants	24 Participants	83 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Unable to walk about -> moderate problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Unable to walk about -> severe problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No data -> no problems	4 Participants	3 Participants	19 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No problems -> no problems	164 Participants	164 Participants	675 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No problems -> slight problems	15 Participants	15 Participants	56 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No problems -> moderate problems	10 Participants	4 Participants	26 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No problems -> severe problems	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No problems -> unable to walk about	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No problems -> no data	3 Participants	0 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Slight problems -> slight problems	18 Participants	29 Participants	87 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Slight problems -> moderate problems	4 Participants	6 Participants	26 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Slight problems -> severe problems	3 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Slight problems -> unable to walk about	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Slight problems -> no data	2 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Moderate problems -> no problems	14 Participants	11 Participants	38 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Moderate problems -> slight problems	13 Participants	17 Participants	47 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Moderate problems -> moderate problems	9 Participants	5 Participants	50 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Moderate problems -> severe problems	2 Participants	4 Participants	8 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Moderate problems -> unable to walk about	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Moderate problems -> no data	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Severe problems -> no problems	2 Participants	4 Participants	15 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Severe problems -> slight problems	2 Participants	2 Participants	13 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Severe problems -> moderate problems	6 Participants	4 Participants	16 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Severe problems -> severe problems	5 Participants	3 Participants	15 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Severe problems -> unable to walk about	1 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Severe problems -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Unable to walk about -> no problems	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Unable to walk about -> slight problems	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Unable to walk about -> unable to walk about	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Unable to walk about -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No data -> slight problems	4 Participants	1 Participants	3 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No data -> moderate problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No data -> severe problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No data -> unable to walk about	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility No data -> no data	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: FAS populaton; LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Unable to wash/dress myself -> slight problems	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No problems -> no problems	223 Participants	232 Participants	906 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No problems -> slight problems	12 Participants	9 Participants	40 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No problems -> moderate problems	8 Participants	0 Participants	12 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No problems -> severe problems	0 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No problems -> unable to wash/dress myself	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No problems -> no data	5 Participants	1 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Slight problems -> no problems	16 Participants	18 Participants	64 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Slight problems -> slight problems	9 Participants	14 Participants	44 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Slight problems -> moderate problems	0 Participants	4 Participants	12 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Slight problems -> severe problems	0 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Slight problems -> unable to wash/dress myself	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Slight problems -> no data	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Moderate problems -> no problems	5 Participants	4 Participants	18 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Moderate problems -> slight problems	5 Participants	6 Participants	20 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Moderate problems -> moderate problems	5 Participants	3 Participants	21 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Moderate problems -> severe problems	0 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Moderate problems -> unable to wash/dress myself	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Moderate problems -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Severe problems -> no problems	0 Participants	1 Participants	8 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Severe problems -> slight problems	1 Participants	0 Participants	3 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Severe problems -> moderate problems	3 Participants	1 Participants	4 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Severe problems -> severe problems	1 Participants	0 Participants	5 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Severe problems -> unable to wash/dress myself	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Severe problems -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Unable to wash/dress myself -> no problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Unable to wash/dress myself -> moderate problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Unable to wash/dress myself -> severe problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Unable to wash/dress myself -> unable to wash/dres	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Unable to wash/dress myself -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No data -> no problems	6 Participants	3 Participants	22 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No data -> slight problems	2 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No data -> moderate problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No data -> severe problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No data -> unable to wash/dress myself	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care No data -> no data	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Moderate problems -> no problems	12 Participants	12 Participants	40 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Moderate problems -> no data	0 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Severe problems -> severe problems	4 Participants	1 Participants	6 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No data -> slight problems	1 Participants	2 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Unable to do usual activities -> slight problems	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Unable to do usual activities -> moderate problems	1 Participants	0 Participants	4 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Unable to do usual activities -> severe problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No problems -> No problems	165 Participants	160 Participants	672 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No problems -> Slight problems	13 Participants	16 Participants	65 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No problems -> Moderate problems	8 Participants	4 Participants	15 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No problems -> Severe problems	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No problems -> unable to do usual activities	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No problems -> no data	4 Participants	0 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Slight problems -> no problems	27 Participants	39 Participants	131 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Slight problems -> slight problems	28 Participants	33 Participants	85 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Slight problems -> moderate problems	5 Participants	6 Participants	26 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Slight problems -> severe problems	2 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Slight problems ->unable to do usual activities	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Slight problems -> no data	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Moderate problems -> slight problems	11 Participants	9 Participants	44 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Moderate problems -> moderate problems	7 Participants	4 Participants	43 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Moderate problems -> severe problems	2 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Moderate problems ->unable to do usual activities	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Severe problems -> no problems	2 Participants	1 Participants	10 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Severe problems -> slight problems	0 Participants	2 Participants	9 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Severe problems -> moderate problems	0 Participants	6 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Severe problems -> unable to do usual activities	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Severe problems -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Unable to do usual activities -> no problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Unable to do usual activities -> unable to do	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Unable to do usual activities -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No data -> no problems	6 Participants	2 Participants	20 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No data -> moderate problems	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No data -> severe problems	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No data -> unable to do usual activities	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities No data -> no data	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No pain/discomfort -> slight pain/discomfort	21 Participants	19 Participants	70 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No pain/discomfort -> severe pain/discomfort	1 Participants	0 Participants	3 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Slight pain/discomfort -> slight pain/discomfort	24 Participants	48 Participants	152 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Severe pain/discomfort -> no data	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Extreme pain/discomfort -> moderate pain/discomf	1 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No pain/discomfort -> no pain/discomfort	120 Participants	119 Participants	495 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No pain/discomfort -> moderate pain/discomfort	7 Participants	1 Participants	20 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No pain/discomfort -> extreme pain/discomfort	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No pain/discomfort -> no data	2 Participants	1 Participants	6 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Slight pain/discomfort -> no pain/discomfort	44 Participants	37 Participants	132 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Slight pain/discomfort -> moderate pain/discomfort	11 Participants	9 Participants	26 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Slight pain/discomfort -> severe pain/discomfort	2 Participants	1 Participants	5 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Slight pain/discomfort -> extreme pain/discomfort	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Slight pain/discomfort -> no data	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Moderate pain/discomfort -> no pain/discomfort	9 Participants	11 Participants	49 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Moderate pain/discomfort -> slight pain/discomfort	19 Participants	17 Participants	78 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Moderate pain/discomfort -> moderate pain/discomf	16 Participants	10 Participants	65 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Moderate pain/discomfort -> severe pain/discomfort	2 Participants	3 Participants	8 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Moderate pain/discomfort -> extreme pain/discomf	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Moderate pain/discomfort -> no data	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Severe pain/discomfort -> no pain/discomfort	3 Participants	6 Participants	15 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Severe pain/discomfort -> slight pain/discomfort	2 Participants	3 Participants	9 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Severe pain/discomfort -> moderate pain/discomfort	5 Participants	5 Participants	13 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Severe pain/discomfort -> severe pain/discomfort	2 Participants	3 Participants	11 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Severe pain/discomfort -> extreme pain/discomfort	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Extreme pain/discomfort -> no pain/discomfort	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Extreme pain/discomfort -> slight pain/discomfort	0 Participants	0 Participants	3 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Extreme pain/discomfort -> severe pain/discomfort	0 Participants	2 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Extreme pain/discomfort -> extreme pain/discomfort	0 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Extreme pain/discomfort -> no data	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No data -> no pain/discomfort	5 Participants	1 Participants	11 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No data -> slight pain/discomfort	3 Participants	3 Participants	11 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No data -> moderate pain/discomfort	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No data -> extreme pain/discomfort	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No data -> severe pain/discomfort	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort No data -> no data	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Moderately anxious -> extremely anxious	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Severely anxious -> not anxious	2 Participants	2 Participants	10 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Severely anxious -> extremely anxious	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Not anxious -> not anxious	137 Participants	142 Participants	588 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Not anxious -> slightly anxious	22 Participants	18 Participants	68 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Not anxious -> moderately anxious	4 Participants	1 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Not anxious -> severely anxious	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Not anxious -> extremely anxious	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Not anxious -> no data	3 Participants	1 Participants	5 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Slightly anxious -> not anxious	35 Participants	43 Participants	177 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Slightly anxious -> slightly anxious	30 Participants	33 Participants	106 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Slightly anxious -> moderately anxious	4 Participants	8 Participants	21 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Slightly anxious -> severely anxious	3 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Slightly anxious -> extremely anxious	0 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Slightly anxious -> no data	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Moderately anxious -> not anxious	15 Participants	11 Participants	37 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Moderately anxious -> slightly anxious	11 Participants	14 Participants	55 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Moderately anxious -> moderately anxious	12 Participants	8 Participants	35 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Moderately anxious -> severely anxious	1 Participants	1 Participants	5 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Moderately anxious -> no data	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Severely anxious -> slightly anxious	3 Participants	2 Participants	14 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Severely anxious -> moderately anxious	5 Participants	3 Participants	13 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Severely anxious -> severely anxious	2 Participants	1 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Severely anxious -> no data	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Extremely anxious -> not anxious	0 Participants	1 Participants	4 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Extremely anxious -> slightly anxious	0 Participants	2 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Extremely anxious -> moderately anxious	1 Participants	0 Participants	8 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Extremely anxious -> severely anxious	0 Participants	2 Participants	2 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Extremely anxious -> extremely anxious	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Extremely anxious -> no data	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression No data -> not anxious	6 Participants	3 Participants	14 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression No data -> slightly anxious	1 Participants	1 Participants	7 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression No data -> moderately anxious	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression No data -> severely anxious	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression No data -> extremely anxious	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression No data -> no data	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Months 6,12

Population: FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.

The WPAI:SHP is 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 are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=114 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=136 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=468 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed Month 6	-0.49 percentage of work time missed Standard Deviation 17.12	-0.59 percentage of work time missed Standard Deviation 15.67	-3.11 percentage of work time missed Standard Deviation 20.68
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed Month 12	0.39 percentage of work time missed Standard Deviation 15.55	-1.95 percentage of work time missed Standard Deviation 18.51	-3.74 percentage of work time missed Standard Deviation 23.83
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed EoT	-0.45 percentage of work time missed Standard Deviation 18.51	-1.30 percentage of work time missed Standard Deviation 18.04	-3.26 percentage of work time missed Standard Deviation 22.88

SECONDARY outcome

Timeframe: Baseline and Months 6, 12

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=114 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=135 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=461 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working Month 12	-19.16 percentage of impairment while working Standard Deviation 23.38	-14.72 percentage of impairment while working Standard Deviation 27.32	-16.68 percentage of impairment while working Standard Deviation 24.16
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working Month 6	-16.94 percentage of impairment while working Standard Deviation 24.10	-12.97 percentage of impairment while working Standard Deviation 21.05	-13.41 percentage of impairment while working Standard Deviation 24.37
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working EoT	-17.81 percentage of impairment while working Standard Deviation 23.45	-13.90 percentage of impairment while working Standard Deviation 27.18	-15.63 percentage of impairment while working Standard Deviation 25.61

SECONDARY outcome

Timeframe: Baseline and Months 6, 12

The WPAI:SHP is 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 arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=114 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=135 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=461 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment Month 6	-16.33 percentage of overall work impairment Standard Deviation 27.58	-12.09 percentage of overall work impairment Standard Deviation 22.26	-13.99 percentage of overall work impairment Standard Deviation 26.04
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment Month 12	-17.83 percentage of overall work impairment Standard Deviation 26.90	-15.38 percentage of overall work impairment Standard Deviation 27.97	-17.27 percentage of overall work impairment Standard Deviation 27.25
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment EoT	-16.83 percentage of overall work impairment Standard Deviation 27.63	-14.16 percentage of overall work impairment Standard Deviation 27.51	-16.15 percentage of overall work impairment Standard Deviation 28.51

SECONDARY outcome

Timeframe: Baseline and Months 6, 12

Population: FAS population with data available at each time point. Only participants with both baseline and post-baseline values during the study are included in the analysis. LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=292 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=285 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1167 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment Month 6	-15.04 percentage of activity Impairment Standard Deviation 27.08	-16.25 percentage of activity Impairment Standard Deviation 24.78	-16.94 percentage of activity Impairment Standard Deviation 28.49
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment Month 12	-16.85 percentage of activity Impairment Standard Deviation 27.57	-14.12 percentage of activity Impairment Standard Deviation 29.87	-18.91 percentage of activity Impairment Standard Deviation 29.26
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment EoT	-16.02 percentage of activity Impairment Standard Deviation 27.63	-14.02 percentage of activity Impairment Standard Deviation 30.29	-18.75 percentage of activity Impairment Standard Deviation 29.14

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 1	24.4 percentage of participants	39.9 percentage of participants	38.3 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 3	40.1 percentage of participants	44.8 percentage of participants	49.6 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 6	40.6 percentage of participants	50.5 percentage of participants	54.7 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 9	47.0 percentage of participants	54.4 percentage of participants	55.8 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 12	51.6 percentage of participants	55.5 percentage of participants	61.2 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT EoT	47.8 percentage of participants	53.2 percentage of participants	58.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT Month 1	63.7 percentage of participants	67.5 percentage of participants	72.8 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT Month 3	69.1 percentage of participants	71.3 percentage of participants	81.8 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT Month 6	70.4 percentage of participants	74.6 percentage of participants	80.5 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT Month 9	70.1 percentage of participants	76.1 percentage of participants	82.9 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT Month 12	72.8 percentage of participants	74.1 percentage of participants	84.4 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT EoT	70.7 percentage of participants	72.4 percentage of participants	82.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT Month 12	58.4 percentage of participants	62.4 percentage of participants	69.0 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT Month 1	46.6 percentage of participants	53.8 percentage of participants	57.0 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT Month 3	53.6 percentage of participants	59.4 percentage of participants	64.6 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT Month 6	56.9 percentage of participants	62.9 percentage of participants	66.1 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT Month 9	57.1 percentage of participants	62.9 percentage of participants	67.7 percentage of participants
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT EoT	56.2 percentage of participants	61.6 percentage of participants	68.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS with data available at each time point. LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT Month 1	46.7 percentage of participants	55.2 percentage of participants	62.0 percentage of participants
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT Month 3	58.2 percentage of participants	67.0 percentage of participants	73.3 percentage of participants
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT Month 6	63.2 percentage of participants	71.8 percentage of participants	76.6 percentage of participants
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT Month 9	67.0 percentage of participants	73.6 percentage of participants	77.8 percentage of participants
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT Month 12	72.9 percentage of participants	75.4 percentage of participants	81.3 percentage of participants
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT EoT	69.1 percentage of participants	73.1 percentage of participants	79.5 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 9	37.1 percentage of participants	43.7 percentage of participants	46.9 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 1	17.2 percentage of participants	26.4 percentage of participants	27.9 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 3	27.0 percentage of participants	35.1 percentage of participants	40.0 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 6	32.3 percentage of participants	39.9 percentage of participants	44.7 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT Month 12	41.9 percentage of participants	47.3 percentage of participants	52.5 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT EoT	38.9 percentage of participants	45.1 percentage of participants	49.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS with data available at each time point. Participants with less \< 8 micturitions per 24 hours at baseline were not included in the analysis. LOCF was used for EoT.

The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT EoT	46.0 percentage of participants	46.3 percentage of participants	55.9 percentage of participants
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT Month 12	46.3 percentage of participants	44.7 percentage of participants	56.4 percentage of participants
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT Month 1	34.5 percentage of participants	29.3 percentage of participants	36.8 percentage of participants
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT Month 3	36.7 percentage of participants	36.6 percentage of participants	46.6 percentage of participants
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT Month 6	42.3 percentage of participants	43.4 percentage of participants	51.4 percentage of participants
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT Month 9	44.5 percentage of participants	41.9 percentage of participants	52.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 1	53.0 percentage of participants	59.2 percentage of participants	64.1 percentage of participants
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 6	64.6 percentage of participants	68.8 percentage of participants	73.8 percentage of participants
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 12	69.7 percentage of participants	73.7 percentage of participants	76.9 percentage of participants
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 3	61.9 percentage of participants	65.7 percentage of participants	72.5 percentage of participants
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 9	65.5 percentage of participants	68.9 percentage of participants	75.1 percentage of participants
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT EoT	66.2 percentage of participants	71.4 percentage of participants	76.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 1	24.9 percentage of participants	28.2 percentage of participants	30.7 percentage of participants
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 3	31.3 percentage of participants	33.9 percentage of participants	42.8 percentage of participants
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 6	35.0 percentage of participants	38.2 percentage of participants	45.4 percentage of participants
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 9	37.5 percentage of participants	40.9 percentage of participants	47.0 percentage of participants
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Month 12	40.6 percentage of participants	40.4 percentage of participants	51.9 percentage of participants
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT EoT	38.3 percentage of participants	39.8 percentage of participants	50.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

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 in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
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 Months 1, 3, 6, 9, 12 and EoT Month 1	36.1 percentage of participants	46.6 percentage of participants	52.6 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 3	47.8 percentage of participants	55.5 percentage of participants	65.1 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 6	50.4 percentage of participants	56.9 percentage of participants	65.8 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 9	53.1 percentage of participants	61.9 percentage of participants	69.2 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 12	59.2 percentage of participants	60.9 percentage of participants	73.2 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT EoT	55.7 percentage of participants	58.2 percentage of participants	70.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

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 in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
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 Months 1, 3, 6, 9, 12 and EoT Month 1	28.5 percentage of participants	36.6 percentage of participants	40.9 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 3	39.6 percentage of participants	43.8 percentage of participants	52.3 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 6	41.6 percentage of participants	47.9 percentage of participants	55.3 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 9	43.7 percentage of participants	51.2 percentage of participants	57.6 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 12	46.9 percentage of participants	50.4 percentage of participants	60.6 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT EoT	44.3 percentage of participants	49.0 percentage of participants	59.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

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 in a micturition diary for 7 days prior to each visit. The PPBC is 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
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 Months 1, 3, 6, 9, 12 and EoT Month 1	32.1 percentage of participants	37.1 percentage of participants	46.0 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 3	43.3 percentage of participants	47.7 percentage of participants	57.6 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 6	46.8 percentage of participants	52.1 percentage of participants	60.6 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 9	49.6 percentage of participants	53.2 percentage of participants	63.0 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT Month 12	57.6 percentage of participants	60.1 percentage of participants	67.0 percentage of participants
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 Months 1, 3, 6, 9, 12 and EoT EoT	52.9 percentage of participants	57.5 percentage of participants	65.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists 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.The PPBC is 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 3	38.9 percentage of participants	44.8 percentage of participants	54.1 percentage of participants
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 1	29.9 percentage of participants	35.5 percentage of participants	42.8 percentage of participants
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 6	42.4 percentage of participants	46.1 percentage of participants	55.9 percentage of participants
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 9	46.5 percentage of participants	50.8 percentage of participants	59.2 percentage of participants
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 12	51.4 percentage of participants	53.6 percentage of participants	63.7 percentage of participants
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT EoT	47.4 percentage of participants	51.4 percentage of participants	61.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total 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.The PPBC is 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.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=302 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=299 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1193 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 3	33.3 percentage of participants	39.1 percentage of participants	45.9 percentage of participants
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 1	25.2 percentage of participants	29.0 percentage of participants	35.5 percentage of participants
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 6	36.8 percentage of participants	41.2 percentage of participants	49.6 percentage of participants
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 9	39.0 percentage of participants	44.0 percentage of participants	51.3 percentage of participants
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Month 12	44.1 percentage of participants	47.6 percentage of participants	54.6 percentage of participants
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT EoT	40.1 percentage of participants	45.2 percentage of participants	53.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12

Population: SAF population with data available at each time point. LOCF was used for EoT.

PVR volume was assessed by ultrasonography or a bladder scanner.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=305 Participants Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=303 Participants Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1206 Participants Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume EoT	1.747 mL Standard Deviation 32.400	7.382 mL Standard Deviation 42.916	8.522 mL Standard Deviation 39.501
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume Month 1	3.179 mL Standard Deviation 27.491	4.549 mL Standard Deviation 33.973	7.894 mL Standard Deviation 38.369
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume Month 3	4.686 mL Standard Deviation 29.354	3.233 mL Standard Deviation 32.679	7.033 mL Standard Deviation 37.328
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume Month 6	1.596 mL Standard Deviation 29.399	3.418 mL Standard Deviation 31.864	6.708 mL Standard Deviation 35.881
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume Month 9	3.074 mL Standard Deviation 32.897	3.436 mL Standard Deviation 32.170	8.229 mL Standard Deviation 40.313
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume Month 12	2.002 mL Standard Deviation 32.453	4.818 mL Standard Deviation 33.764	7.946 mL Standard Deviation 38.118

Adverse Events

Mirabegron 50 mg

Serious events: 8 serious events

Other events: 27 other events

Deaths: 1 deaths

Solifenacin 5 mg

Serious events: 8 serious events

Other events: 33 other events

Deaths: 0 deaths

Solifenacin 5 mg + Mirabegron 50 mg

Serious events: 51 serious events

Other events: 115 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Mirabegron 50 mg n=305 participants at risk Participants received mirabegron 50 mg once a day for 52 weeks.	Solifenacin 5 mg n=303 participants at risk Participants received solifenacin 5 mg once a day for 52 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=1206 participants at risk Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Gastrointestinal disorders Dry mouth	3.9% 12/305 • From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) The total number of deaths data includes deaths reported after the abovementioned timeframe.	5.9% 18/303 • From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) The total number of deaths data includes deaths reported after the abovementioned timeframe.	6.1% 74/1206 • From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) The total number of deaths data includes deaths reported after the abovementioned timeframe.
Infections and infestations Nasopharyngitis	5.2% 16/305 • From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) The total number of deaths data includes deaths reported after the abovementioned timeframe.	5.0% 15/303 • From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) The total number of deaths data includes deaths reported after the abovementioned timeframe.	3.6% 43/1206 • From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) The total number of deaths data includes deaths reported after the abovementioned timeframe.

Additional Information

Clinical Trial Disclosure

Astellas Pharma Europe B.V.

Phone: +44 (0) 20 3379 8000

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER