Trial Outcomes & Findings for A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder (NCT NCT00662909)

Last Updated: 2024-11-20

Results Overview

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2149 participants

Primary outcome timeframe

Baseline and Week 12 (Final Visit)

Results posted on

2024-11-20

Participant Flow

After screening, 2149 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1329 eligible patients were randomly assigned to receive mirabegron 50 mg, mirabegron 100 mg or a matching placebo for 12 weeks.

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Overall Study STARTED	454	442	433
Overall Study Safety Analysis Set (SAF)	453	442	433
Overall Study Full Analysis Set (FAS)	433	425	412
Overall Study Full Analysis Set Incontinence (FAS-I)	325	312	296
Overall Study COMPLETED	385	383	380
Overall Study NOT COMPLETED	69	59	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Overall Study Adverse Event	17	18	19
Overall Study Lack of Efficacy	9	1	5
Overall Study Withdrawal by Subject	29	22	16
Overall Study Lost to Follow-up	2	9	3
Overall Study Protocol Violation	7	4	5
Overall Study Randomized- never received study drug	1	0	0
Overall Study Non-compliance with study procedures	3	3	2
Overall Study Physician Decision	1	1	2
Overall Study Eligibility criterion not met	0	1	1

Baseline Characteristics

A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=453 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=442 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=433 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks	Total n=1328 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 13.79 • n=5 Participants	59.2 years STANDARD_DEVIATION 13.53 • n=7 Participants	61.0 years STANDARD_DEVIATION 13.25 • n=5 Participants	60.1 years STANDARD_DEVIATION 13.54 • n=4 Participants
Sex: Female, Male Female	345 Participants n=5 Participants	322 Participants n=7 Participants	320 Participants n=5 Participants	987 Participants n=4 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	120 Participants n=7 Participants	113 Participants n=5 Participants	341 Participants n=4 Participants
Race/Ethnicity, Customized White	395 participants n=5 Participants	391 participants n=7 Participants	381 participants n=5 Participants	1167 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	47 participants n=5 Participants	32 participants n=7 Participants	37 participants n=5 Participants	116 participants n=4 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	12 participants n=7 Participants	8 participants n=5 Participants	26 participants n=4 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	19 participants n=4 Participants
Type of overactive bladder (OAB) Urge Incontinence	127 participants n=5 Participants	144 participants n=7 Participants	123 participants n=5 Participants	394 participants n=4 Participants
Type of overactive bladder (OAB) Mixed	185 participants n=5 Participants	160 participants n=7 Participants	161 participants n=5 Participants	506 participants n=4 Participants
Type of overactive bladder (OAB) Frequency	141 participants n=5 Participants	138 participants n=7 Participants	149 participants n=5 Participants	428 participants n=4 Participants
Duration of OAB symptoms	90.6 months STANDARD_DEVIATION 106.95 • n=5 Participants	83.8 months STANDARD_DEVIATION 93.76 • n=7 Participants	90.8 months STANDARD_DEVIATION 107.83 • n=5 Participants	88.4 months STANDARD_DEVIATION 103.02 • n=4 Participants
Mean number of micturitions per 24 hours	11.52 micturitions STANDARD_DEVIATION 3.273 • n=5 Participants	11.78 micturitions STANDARD_DEVIATION 3.447 • n=7 Participants	11.69 micturitions STANDARD_DEVIATION 3.357 • n=5 Participants	11.66 micturitions STANDARD_DEVIATION 3.358 • n=4 Participants
Mean volume voided per micturition	157.2 mL STANDARD_DEVIATION 60.16 • n=5 Participants	155.2 mL STANDARD_DEVIATION 58.67 • n=7 Participants	157.6 mL STANDARD_DEVIATION 60.20 • n=5 Participants	156.7 mL STANDARD_DEVIATION 59.64 • n=4 Participants
Mean number of urgency episodes (grade 3 or 4) per 24 hours	5.63 urgency episodes STANDARD_DEVIATION 3.265 • n=5 Participants	5.92 urgency episodes STANDARD_DEVIATION 3.829 • n=7 Participants	5.95 urgency episodes STANDARD_DEVIATION 3.610 • n=5 Participants	5.83 urgency episodes STANDARD_DEVIATION 3.573 • n=4 Participants
Mean level of urgency	2.45 Scores on a scale STANDARD_DEVIATION 0.538 • n=5 Participants	2.46 Scores on a scale STANDARD_DEVIATION 0.541 • n=7 Participants	2.45 Scores on a scale STANDARD_DEVIATION 0.544 • n=5 Participants	2.45 Scores on a scale STANDARD_DEVIATION 0.541 • n=4 Participants
Mean number of nocturia episodes per 24 hours	1.96 nocturia episodes STANDARD_DEVIATION 1.639 • n=5 Participants	1.89 nocturia episodes STANDARD_DEVIATION 1.602 • n=7 Participants	2.06 nocturia episodes STANDARD_DEVIATION 1.715 • n=5 Participants	1.97 nocturia episodes STANDARD_DEVIATION 1.652 • n=4 Participants
Mean number of pads used per 24 hours	0.99 pads STANDARD_DEVIATION 1.814 • n=5 Participants	0.94 pads STANDARD_DEVIATION 1.685 • n=7 Participants	0.90 pads STANDARD_DEVIATION 1.722 • n=5 Participants	0.95 pads STANDARD_DEVIATION 1.741 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12 (Final Visit)

Population: The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was used in this analysis.

Outcome measures

Outcome measures
Measure	Placebo n=325 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=312 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=296 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours	-1.13 Incontinence episodes Standard Error 0.112	-1.47 Incontinence episodes Standard Error 0.114	-1.63 Incontinence episodes Standard Error 0.117

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.

The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours	-1.05 Micturitions Standard Error 0.132	-1.66 Micturitions Standard Error 0.133	-1.75 Micturitions Standard Error 0.135

SECONDARY outcome

Timeframe: Baseline and Week 12

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=424 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition	7.0 mL Standard Error 2.41	18.2 mL Standard Error 2.44	18.0 mL Standard Error 2.47

SECONDARY outcome

Timeframe: Baseline and Week 4

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=325 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=309 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=293 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours	-0.72 Incontinence episodes Standard Error 0.116	-1.20 Incontinence episodes Standard Error 0.119	-1.18 Incontinence episodes Standard Error 0.122

SECONDARY outcome

Timeframe: Baseline and Week 4

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=422 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=409 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours	-0.77 Micturitions Standard Error 0.127	-1.19 Micturitions Standard Error 0.129	-1.37 Micturitions Standard Error 0.131

SECONDARY outcome

Timeframe: Baseline and Weeks 8 and 12

Population: The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as "N". LOCF was not utilized.

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=325 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=312 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=296 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours Week 12 [N=283; 278; 267]	-1.13 Incontinence episodes Standard Error 0.114	-1.45 Incontinence episodes Standard Error 0.115	-1.60 Incontinence episodes Standard Error 0.118
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours Week 8 [N= 296; 288; 279]	-0.93 Incontinence episodes Standard Error 0.116	-1.32 Incontinence episodes Standard Error 0.118	-1.61 Incontinence episodes Standard Error 0.120

SECONDARY outcome

Timeframe: Baseline and Weeks 8 and 12

Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not used in this analysis. The number of patients included in the calculation for each time point is noted as "N".

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours Week 8 [N=394; 394; 391]	-0.94 Micturitions Standard Error 0.134	-1.52 Micturitions Standard Error 0.133	-1.74 Micturitions Standard Error 0.134
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours Week 12 [N=382; 379; 376]	-1.02 Micturitions Standard Error 0.139	-1.71 Micturitions Standard Error 0.139	-1.72 Micturitions Standard Error 0.140

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as "N".

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition Week 4 [N=433; 421; 409]	7.1 mL Standard Error 1.90	15.2 mL Standard Error 1.93	19.2 mL Standard Error 1.95
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition Week 8 [N=394; 394; 391]	5.4 mL Standard Error 2.27	19.0 mL Standard Error 2.27	19.4 mL Standard Error 2.28
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition Week 12 [N=382; 378; 376]	7.2 mL Standard Error 2.58	19.7 mL Standard Error 2.59	18.7 mL Standard Error 2.60

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 post baseline micturition measurement in the visit diary \& at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.

The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=325 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=312 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=296 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours Week 4 [N=319; 294; 288]	-0.62 Urgency incontinence episodes Standard Error 0.097	-1.09 Urgency incontinence episodes Standard Error 0.101	-1.05 Urgency incontinence episodes Standard Error 0.102
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours Week 8 [N=291; 273; 278]	-0.81 Urgency incontinence episodes Standard Error 0.098	-1.23 Urgency incontinence episodes Standard Error 0.102	-1.44 Urgency incontinence episodes Standard Error 0.101
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours Week 12 [N= 278; 264; 265]	-0.94 Urgency incontinence episodes Standard Error 0.106	-1.32 Urgency incontinence episodes Standard Error 0.108	-1.45 Urgency incontinence episodes Standard Error 0.108
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours Final Visit (LOCF) [N= 319; 297; 291]	-0.89 Urgency incontinence episodes Standard Error 0.100	-1.32 Urgency incontinence episodes Standard Error 0.104	-1.45 Urgency incontinence episodes Standard Error 0.105

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours Week 4 [N= 430; 420; 408]	-0.75 Urgency episodes Standard Error 0.145	-1.03 Urgency episodes Standard Error 0.147	-1.45 Urgency episodes Standard Error 0.149
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours Week 8 [N= 393; 392; 389]	-0.91 Urgency episodes Standard Error 0.159	-1.58 Urgency episodes Standard Error 0.159	-1.80 Urgency episodes Standard Error 0.160
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours Week 12 [N= 382; 376; 374]	-0.86 Urgency episodes Standard Error 0.170	-1.63 Urgency episodes Standard Error 0.171	-1.79 Urgency episodes Standard Error 0.172
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours Final Visit (LOCF) [N= 432; 424; 411]	-0.82 Urgency episodes Standard Error 0.161	-1.57 Urgency episodes Standard Error 0.162	-1.76 Urgency episodes Standard Error 0.165

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".

Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency Week 4 [N= 430; 421; 408]	-0.08 Scores on a scale Standard Error 0.021	-0.12 Scores on a scale Standard Error 0.022	-0.18 Scores on a scale Standard Error 0.022
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency Week 8 [N= 393; 393; 389]	-0.10 Scores on a scale Standard Error 0.026	-0.17 Scores on a scale Standard Error 0.026	-0.21 Scores on a scale Standard Error 0.026
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency Week 12 [N= 382; 377; 374]	-0.09 Scores on a scale Standard Error 0.028	-0.18 Scores on a scale Standard Error 0.028	-0.21 Scores on a scale Standard Error 0.028
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency Final Visit (LOCF) [N= 432; 425; 411]	-0.08 Scores on a scale Standard Error 0.026	-0.19 Scores on a scale Standard Error 0.026	-0.21 Scores on a scale Standard Error 0.027

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.

Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours Week 4 [N= 366; 345; 353]	-0.29 Nocturia episodes Standard Error 0.063	-0.43 Nocturia episodes Standard Error 0.065	-0.40 Nocturia episodes Standard Error 0.064
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours Week 8 [N= 333; 324; 340]	-0.24 Nocturia episodes Standard Error 0.063	-0.54 Nocturia episodes Standard Error 0.064	-0.55 Nocturia episodes Standard Error 0.062
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours Week 12 [N= 323; 311; 328]	-0.32 Nocturia episodes Standard Error 0.064	-0.59 Nocturia episodes Standard Error 0.066	-0.58 Nocturia episodes Standard Error 0.064
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours Final Visit (LOCF) [N= 366; 348; 356]	-0.38 Nocturia episodes Standard Error 0.063	-0.57 Nocturia episodes Standard Error 0.065	-0.57 Nocturia episodes Standard Error 0.064

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.

The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours Week 4 [N= 176; 165; 156]	-0.40 pads Standard Error 0.111	-0.77 pads Standard Error 0.115	-0.76 pads Standard Error 0.118
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours Week 8 [N= 159; 154; 152]	-0.56 pads Standard Error 0.116	-0.96 pads Standard Error 0.118	-1.03 pads Standard Error 0.119
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours Week 12 [N= 152; 145; 147]	-0.63 pads Standard Error 0.128	-1.04 pads Standard Error 0.131	-1.09 pads Standard Error 0.130
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours Final Visit (LOCF) [N= 176; 166; 159]	-0.63 pads Standard Error 0.120	-1.03 pads Standard Error 0.123	-1.06 pads Standard Error 0.126

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.

Outcome measures

Outcome measures
Measure	Placebo n=325 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=312 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=296 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Final Visit (LOCF) [N= 325; 312; 296]	33.8 Percentage of participants	40.7 Percentage of participants	49.0 Percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Week 4 [N= 325; 309; 293]	26.8 Percentage of participants	30.1 Percentage of participants	32.8 Percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Week 8 [N= 296; 288; 279]	29.4 Percentage of participants	35.4 Percentage of participants	43.4 Percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Week 12 [N=283; 278; 267]	35.0 Percentage of participants	42.8 Percentage of participants	48.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.

The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.

Outcome measures

Outcome measures
Measure	Placebo n=325 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=312 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=296 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Week 4 [N= 325; 309; 293]	48.0 Percentage of participants	56.6 Percentage of participants	59.0 Percentage of participants
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Week 8 [N= 296; 288; 279]	52.0 Percentage of participants	61.8 Percentage of participants	73.8 Percentage of participants
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Week 12 [N= 283; 278; 267]	61.5 Percentage of participants	68.7 Percentage of participants	74.5 Percentage of participants
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit Final Visit (LOCF) [N= 325; 312; 296]	59.4 Percentage of participants	66.7 Percentage of participants	73.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".

Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score Week 4 [ N= 354; 346; 335]	-9.7 Scores on a scale Standard Error 0.87	-13.5 Scores on a scale Standard Error 0.88	-16.1 Scores on a scale Standard Error 0.90
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score Week 8 [N= 325; 321; 323]	-11.6 Scores on a scale Standard Error 0.95	-16.0 Scores on a scale Standard Error 0.96	-20.3 Scores on a scale Standard Error 0.96
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score Week 12 [N=315; 308; 317]	-11.3 Scores on a scale Standard Error 1.04	-17.4 Scores on a scale Standard Error 1.05	-20.7 Scores on a scale Standard Error 1.03
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score Final Visit (LOCF) [N= 356; 350; 344]	-10.8 Scores on a scale Standard Error 0.97	-17.0 Scores on a scale Standard Error 0.98	-20.2 Scores on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".

Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score Week 4 [N= 352; 345; 335]	9.2 Scores on a scale Standard Error 0.80	12.1 Scores on a scale Standard Error 0.81	13.7 Scores on a scale Standard Error 0.82
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score Week 8 [N= 324; 321; 322]	11.4 Scores on a scale Standard Error 0.87	14.7 Scores on a scale Standard Error 0.88	17.0 Scores on a scale Standard Error 0.88
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score Week 12 [N= 315; 308; 318]	11.1 Scores on a scale Standard Error 0.95	15.2 Scores on a scale Standard Error 0.96	17.5 Scores on a scale Standard Error 0.94
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score Final Visit (LOCF) [N= 355; 350; 344]	10.7 Scores on a scale Standard Error 0.89	14.8 Scores on a scale Standard Error 0.90	17.3 Scores on a scale Standard Error 0.90

SECONDARY outcome

Timeframe: Baseline and Week12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Week 12 [N= 136; 138; 131]	0.03 percent work time missed Standard Deviation 10.18	-0.2 percent work time missed Standard Deviation 2.05	-1.3 percent work time missed Standard Deviation 7.38
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Final Visit (LOCF) [N= 141; 140; 131]	0.3 percent work time missed Standard Deviation 10.00	-0.2 percent work time missed Standard Deviation 2.03	-1.3 percent work time missed Standard Deviation 7.38

SECONDARY outcome

Timeframe: Baseline and Week 12

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Week 12 [N= 142; 143; 137]	-7.1 percent impairment while working Standard Deviation 24.04	-8.5 percent impairment while working Standard Deviation 21.76	-8.2 percent impairment while working Standard Deviation 22.36
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Final Visit (LOCF) [N= 147; 146; 137]	-6.2 percent impairment while working Standard Deviation 24.62	-8.6 percent impairment while working Standard Deviation 21.56	-8.2 percent impairment while working Standard Deviation 22.36

SECONDARY outcome

Timeframe: Baseline and Week 12

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Week 12 [ N= 135; 138; 130]	-7.1 percent overall work impairment Standard Deviation 24.27	-8.2 percent overall work impairment Standard Deviation 21.84	-8.7 percent overall work impairment Standard Deviation 23.19
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Final Visit (LOCF) [N= 140; 140; 130]	-6.1 percent overall work impairment Standard Deviation 24.85	-8.2 percent overall work impairment Standard Deviation 21.68	-8.7 percent overall work impairment Standard Deviation 23.19

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Week 12 [N= 368; 368; 363]	-7.5 percent activity impairment Standard Deviation 24.02	-12.9 percent activity impairment Standard Deviation 25.19	-10.8 percent activity impairment Standard Deviation 24.44
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Final Visit (LOCF) [N= 386; 380; 368]	-6.7 percent activity impairment Standard Deviation 24.51	-12.3 percent activity impairment Standard Deviation 25.43	-10.7 percent activity impairment Standard Deviation 24.55

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Week 4 [N= 413; 406; 396]	-0.57 Scores on a scale Standard Deviation 12.902	0.85 Scores on a scale Standard Deviation 11.850	0.52 Scores on a scale Standard Deviation 13.607
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Week 8 [N= 385; 385; 387]	1.15 Scores on a scale Standard Deviation 12.718	2.17 Scores on a scale Standard Deviation 11.749	2.34 Scores on a scale Standard Deviation 13.239
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Week 12 [N= 377; 369; 378]	1.92 Scores on a scale Standard Deviation 12.532	3.60 Scores on a scale Standard Deviation 11.827	3.89 Scores on a scale Standard Deviation 12.101
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Final Visit (LOCF) [N=424; 417; 410]	1.46 Scores on a scale Standard Deviation 13.090	3.04 Scores on a scale Standard Deviation 12.142	3.52 Scores on a scale Standard Deviation 12.184

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) Week 12 [N=373; 376; 371]	-0.6 Scores on a scale Standard Error 0.05	-0.7 Scores on a scale Standard Error 0.05	-0.8 Scores on a scale Standard Error 0.05
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) Final Visit (LOCF) [N=392; 388; 377]	-0.5 Scores on a scale Standard Error 0.05	-0.7 Scores on a scale Standard Error 0.05	-0.8 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) Week 12 [N= 371; 375; 368]	0.72 Scores on a scale Standard Error 0.159	1.57 Scores on a scale Standard Error 0.158	2.09 Scores on a scale Standard Error 0.159
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) Final Visit (LOCF) [N= 390; 387; 373]	0.70 Scores on a scale Standard Error 0.155	1.55 Scores on a scale Standard Error 0.156	2.09 Scores on a scale Standard Error 0.159

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.

The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician Week 4 [N= 429; 422; 405]	0.0 Physician visits Standard Deviation 0.17	-0.0 Physician visits Standard Deviation 0.23	0.0 Physician visits Standard Deviation 0.12
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician Week 8 [N= 392; 389; 389]	0.0 Physician visits Standard Deviation 0.17	-0.0 Physician visits Standard Deviation 0.19	0.0 Physician visits Standard Deviation 0.10
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician Week 12 [N= 381; 377; 381]	-0.0 Physician visits Standard Deviation 0.15	-0.0 Physician visits Standard Deviation 0.21	0.0 Physician visits Standard Deviation 0.14
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician Final Visit (LOCF) [N= 430; 422; 410]	-0.0 Physician visits Standard Deviation 0.14	-0.0 Physician visits Standard Deviation 0.21	0.0 Physician visits Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit Improvement at Week 12 [N= 373; 376; 371]	48.3 Percentage of participants	50.8 Percentage of participants	57.1 Percentage of participants
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit Improvement at Final Visit [N= 392; 388; 377]	47.4 Percentage of participants	50.8 Percentage of participants	56.8 Percentage of participants
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit Major Improvement at Week 12 [N= 373; 376; 371]	17.7 Percentage of participants	18.6 Percentage of participants	27.8 Percentage of participants
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit Major Improvement at Final Visit [N=392; 388; 377]	17.3 Percentage of participants	18.6 Percentage of participants	27.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score No problem -> No problem	318 participants	304 participants	291 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score No problem -> Some problems	15 participants	17 participants	24 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score No problem -> Confined to bed	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score No problem -> Missing data	6 participants	2 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Some problems -> No problems	41 participants	37 participants	41 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Some problems -> Some problems	49 participants	58 participants	54 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Some problems -> Confined to bed	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Some problems -> Missing data	1 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Confined -> No problems	1 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Confined -> Some problems	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Confined -> Confined to bed	0 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Confined -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Missing data -> No problems	2 participants	3 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Missing data -> Some problems	0 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Missing data -> Confined to bed	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score Missing data -> Missing data	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Some problems -> No problems	7 participants	8 participants	8 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Some problems -> Some problems	5 participants	10 participants	5 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Some problems -> Unable to wash or dress myself	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Some problems -> Missing data	1 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Unable to wash or dress myself -> No problems	2 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Unable to wash or dress myself -> Some problems	1 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Unable to wash or dress -> Unable to wash or dress	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Unable to wash or dress myself -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Missing data -> No problems	2 participants	3 participants	4 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Missing data -> Some problems	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Missing data -> Unable to wash or dress myself	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score Missing data -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score No problem -> No problem	398 participants	392 participants	386 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score No problem -> Some problems	10 participants	9 participants	6 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score No problem -> Unable to wash or dress myself	1 participants	0 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score No problem -> Missing data	6 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Some problems -> Some problems	52 participants	50 participants	48 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Missing data -> Some problems	0 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score No problem -> No problem	303 participants	297 participants	287 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score No problem -> Some problems	22 participants	19 participants	19 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score No problem -> Unable	0 participants	1 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score No problem -> Missing data	6 participants	2 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Some problems -> No problems	47 participants	45 participants	50 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Some problems -> Unable	0 participants	1 participants	2 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Some problems -> Missing data	1 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Unable -> No problems	0 participants	0 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Unable -> Some problems	1 participants	5 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Unable -> Unable	0 participants	1 participants	2 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Unable -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Missing data -> No problems	1 participants	2 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Missing data -> Unable	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score Missing data -> Missing data	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Extreme pain -> Moderate pain	7 participants	8 participants	5 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Missing data -> Moderate pain	0 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Missing data -> Extreme pain	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Missing data -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score No pain -> No pain	201 participants	198 participants	204 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score No pain -> Moderate pain	34 participants	32 participants	31 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score No pain -> Extreme pain	1 participants	1 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score No pain -> Missing data	3 participants	2 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Moderate pain -> No pain	76 participants	79 participants	57 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Moderate pain -> Moderate pain	92 participants	84 participants	95 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Moderate pain -> Extreme pain	3 participants	9 participants	8 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Moderate pain -> Missing data	3 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Extreme pain -> No pain	3 participants	2 participants	3 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Extreme pain -> Extreme pain	8 participants	6 participants	6 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Extreme pain -> Missing data	1 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score Missing data -> No pain	1 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.

Outcome measures

Outcome measures
Measure	Placebo n=433 Participants Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=425 Participants Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=412 Participants Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Not anxious -> Not anxious	239 participants	250 participants	250 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Not anxious -> Moderately anxious	30 participants	36 participants	33 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Not anxious -> Extremely anxious	2 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Not anxious -> Missing data	4 participants	1 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Moderately anxious -> Not anxious	58 participants	48 participants	46 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Extremely anxious -> Extremely anxious	7 participants	0 participants	2 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Missing data -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Moderately anxious -> Moderately anxious	76 participants	71 participants	75 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Moderately anxious -> Extremely anxious	7 participants	1 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Moderately anxious -> Missing data	3 participants	2 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Extremely anxious -> Not anxious	1 participants	2 participants	2 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Extremely anxious -> Moderately anxious	5 participants	9 participants	2 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Extremely anxious -> Missing data	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Missing data -> Not anxious	1 participants	4 participants	1 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Missing data -> Moderately anxious	0 participants	0 participants	0 participants
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score Missing data -> Extremely anxious	0 participants	0 participants	0 participants

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 30 other events

Deaths: 0 deaths

Mirabegron 50 mg

Serious events: 11 serious events

Other events: 27 other events

Deaths: 0 deaths

Mirabegron 100 mg

Serious events: 14 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=453 participants at risk Participants received matching placebo tablets orally once a day for 12 weeks	Mirabegron 50 mg n=442 participants at risk Participants received mirabegron 50 mg tablets orally once a day for 12 weeks	Mirabegron 100 mg n=433 participants at risk Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
Vascular disorders Hypertension	6.6% 30/453 • Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake	6.1% 27/442 • Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake	4.8% 21/433 • Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake

Additional Information

Medical Director, Medical Sciences

Astellas Pharma Global Development, Inc.

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 at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
Publication restrictions are in place

Restriction type: OTHER