Trial Outcomes & Findings for A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients (NCT NCT01745094)

Last Updated: 2018-02-28

Results Overview

TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

223 participants

Primary outcome timeframe

From first dose of study drug up to weeks 16

Results posted on

2018-02-28

Participant Flow

Participants with overactive bladder (OAB) were enrolled in 29 sites in Japan.

Participant milestones

Participant milestones
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Overall Study STARTED	35	37	58	93
Overall Study COMPLETED	30	37	46	90
Overall Study NOT COMPLETED	5	0	12	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 25 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Overall Study Not Meeting the Eligibility Criteria	1	3	0
Overall Study Adverse Event	0	3	0
Overall Study Withdrawal by Subject	2	1	2
Overall Study Protocol Violation	1	3	1
Overall Study Need Further Examinations Due to Biopsy	0	1	0
Overall Study Show no Stable Solifenacin Intake	0	1	0
Overall Study Untenable Due to Recurrent Cystitis	1	0	0

Baseline Characteristics

Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=35 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=58 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.	Total n=223 Participants Total of all reporting groups
Age, Continuous	65.6 Years STANDARD_DEVIATION 8.71 • n=35 Participants	62.8 Years STANDARD_DEVIATION 10.27 • n=37 Participants	66.9 Years STANDARD_DEVIATION 9.47 • n=58 Participants	63.8 Years STANDARD_DEVIATION 10.34 • n=93 Participants	64.7 Years STANDARD_DEVIATION 9.92 • n=223 Participants
Sex: Female, Male Female	30 Participants n=35 Participants	32 Participants n=37 Participants	45 Participants n=58 Participants	79 Participants n=93 Participants	186 Participants n=223 Participants
Sex: Female, Male Male	5 Participants n=35 Participants	5 Participants n=37 Participants	13 Participants n=58 Participants	14 Participants n=93 Participants	37 Participants n=223 Participants
Overactive Bladder Symptom Score (OABSS)	7.1 Units on a Scale STANDARD_DEVIATION 2.31 • n=33 Participants • Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.	8.5 Units on a Scale STANDARD_DEVIATION 2.36 • n=37 Participants • Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.	7.5 Units on a Scale STANDARD_DEVIATION 2.67 • n=55 Participants • Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.	8.1 Units on a Scale STANDARD_DEVIATION 2.45 • n=93 Participants • Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.	7.8 Units on a Scale STANDARD_DEVIATION 2.49 • n=218 Participants • Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.
Overactive Bladder questionnaire Short Form (OAB-q SF) Score: Symptom Severity	33.94 Units on a Scale STANDARD_DEVIATION 20.386 • n=33 Participants • FAS participants with available data are included in the analysis.	39.37 Units on a Scale STANDARD_DEVIATION 20.470 • n=37 Participants • FAS participants with available data are included in the analysis.	32.12 Units on a Scale STANDARD_DEVIATION 17.701 • n=55 Participants • FAS participants with available data are included in the analysis.	31.29 Units on a Scale STANDARD_DEVIATION 19.205 • n=93 Participants • FAS participants with available data are included in the analysis.	33.27 Units on a Scale STANDARD_DEVIATION 19.328 • n=218 Participants • FAS participants with available data are included in the analysis.
OAB-q SF Score: Total Health-Related Quality of Life (HRQOL)	73.71 Units on a Scale STANDARD_DEVIATION 18.662 • n=33 Participants • FAS participants with available data are included in the analysis.	70.31 Units on a Scale STANDARD_DEVIATION 18.873 • n=37 Participants • FAS participants with available data are included in the analysis.	75.10 Units on a Scale STANDARD_DEVIATION 17.708 • n=55 Participants • FAS participants with available data are included in the analysis.	76.06 Units on a Scale STANDARD_DEVIATION 19.341 • n=93 Participants • FAS participants with available data are included in the analysis.	74.49 Units on a Scale STANDARD_DEVIATION 18.743 • n=218 Participants • FAS participants with available data are included in the analysis.
Number of Micturitions per 24 Hours	10.38 micturitions STANDARD_DEVIATION 2.128 • n=33 Participants • FAS participants with available data are included in the analysis.	11.12 micturitions STANDARD_DEVIATION 2.722 • n=37 Participants • FAS participants with available data are included in the analysis.	9.81 micturitions STANDARD_DEVIATION 1.918 • n=55 Participants • FAS participants with available data are included in the analysis.	10.15 micturitions STANDARD_DEVIATION 2.331 • n=93 Participants • FAS participants with available data are included in the analysis.	10.26 micturitions STANDARD_DEVIATION 2.302 • n=218 Participants • FAS participants with available data are included in the analysis.
Number of Urgency Episodes per 24 Hours	2.86 urgency episodes STANDARD_DEVIATION 2.433 • n=30 Participants • FAS participants with available data are included in the analysis.	4.12 urgency episodes STANDARD_DEVIATION 2.586 • n=36 Participants • FAS participants with available data are included in the analysis.	2.86 urgency episodes STANDARD_DEVIATION 1.997 • n=49 Participants • FAS participants with available data are included in the analysis.	3.63 urgency episodes STANDARD_DEVIATION 2.846 • n=90 Participants • FAS participants with available data are included in the analysis.	3.42 urgency episodes STANDARD_DEVIATION 2.586 • n=205 Participants • FAS participants with available data are included in the analysis.
Number of Incontinence Episodes per 24 Hours	1.45 incontinence episodes STANDARD_DEVIATION 1.454 • n=14 Participants • FAS participants with available data are included in the analysis.	1.54 incontinence episodes STANDARD_DEVIATION 1.248 • n=28 Participants • FAS participants with available data are included in the analysis.	2.09 incontinence episodes STANDARD_DEVIATION 2.121 • n=29 Participants • FAS participants with available data are included in the analysis.	1.51 incontinence episodes STANDARD_DEVIATION 1.520 • n=60 Participants • FAS participants with available data are included in the analysis.	1.64 incontinence episodes STANDARD_DEVIATION 1.616 • n=131 Participants • FAS participants with available data are included in the analysis.
Number of Urge Incontinence Episodes per 24 Hours	1.42 urge incontinence episodes STANDARD_DEVIATION 1.506 • n=11 Participants • FAS participants with available data are included in the analysis.	1.42 urge incontinence episodes STANDARD_DEVIATION 1.243 • n=28 Participants • FAS participants with available data are included in the analysis.	1.69 urge incontinence episodes STANDARD_DEVIATION 1.366 • n=26 Participants • FAS participants with available data are included in the analysis.	1.30 urge incontinence episodes STANDARD_DEVIATION 1.138 • n=52 Participants • FAS participants with available data are included in the analysis.	1.43 urge incontinence episodes STANDARD_DEVIATION 1.245 • n=117 Participants • FAS participants with available data are included in the analysis.
Volume Voided per Micturition	158.627 mL STANDARD_DEVIATION 47.0511 • n=33 Participants • FAS participants with available data are included in the analysis.	158.633 mL STANDARD_DEVIATION 43.6678 • n=37 Participants • FAS participants with available data are included in the analysis.	182.362 mL STANDARD_DEVIATION 56.3405 • n=55 Participants • FAS participants with available data are included in the analysis.	173.658 mL STANDARD_DEVIATION 47.5973 • n=93 Participants • FAS participants with available data are included in the analysis.	171.029 mL STANDARD_DEVIATION 49.7826 • n=218 Participants • FAS participants with available data are included in the analysis.
Number of Nocturia Episodes per Night	1.79 nocturia episodes STANDARD_DEVIATION 1.075 • n=28 Participants • FAS participants with available data are included in the analysis.	1.55 nocturia episodes STANDARD_DEVIATION 0.783 • n=29 Participants • FAS participants with available data are included in the analysis.	1.85 nocturia episodes STANDARD_DEVIATION 1.006 • n=50 Participants • FAS participants with available data are included in the analysis.	1.72 nocturia episodes STANDARD_DEVIATION 1.084 • n=81 Participants • FAS participants with available data are included in the analysis.	1.74 nocturia episodes STANDARD_DEVIATION 1.018 • n=188 Participants • FAS participants with available data are included in the analysis.
Postvoid Residual (PVR) Volume	14.95 mL STANDARD_DEVIATION 23.214 • n=35 Participants	10.51 mL STANDARD_DEVIATION 16.066 • n=37 Participants	13.93 mL STANDARD_DEVIATION 17.188 • n=58 Participants	12.11 mL STANDARD_DEVIATION 20.199 • n=93 Participants	12.76 mL STANDARD_DEVIATION 19.273 • n=223 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to weeks 16

Population: SAF

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=35 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=58 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Severe	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Drug-related TEAEs	6 Participants	6 Participants	12 Participants	28 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Deaths	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Serious TEAEs	1 Participants	1 Participants	5 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Drug-related Serious TEAEs	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs leading to permanent discontinuation (PD)	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Drug-related TEAEs leading to PD	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAEs	23 Participants	21 Participants	42 Participants	69 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Mild	22 Participants	20 Participants	40 Participants	67 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Moderate	1 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and week 8, 16

Population: FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.

The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in OABSS Total Score Week 8	-3.5 units on a scale Standard Deviation 2.32	-2.1 units on a scale Standard Deviation 2.22	-3.5 units on a scale Standard Deviation 2.52	-2.5 units on a scale Standard Deviation 2.32
Change From Baseline in OABSS Total Score Week 16	-3.5 units on a scale Standard Deviation 2.60	-3.9 units on a scale Standard Deviation 2.70	-3.6 units on a scale Standard Deviation 2.90	-4.0 units on a scale Standard Deviation 2.90
Change From Baseline in OABSS Total Score Week 16 (LOCF)	-3.4 units on a scale Standard Deviation 2.95	-3.9 units on a scale Standard Deviation 2.70	-3.6 units on a scale Standard Deviation 2.86	-4.0 units on a scale Standard Deviation 2.90

SECONDARY outcome

Timeframe: Week 8 and 16

Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Number of Participants Who Achieved Normalization for OABSS Total Score Week 8	19 Participants	8 Participants	28 Participants	26 Participants
Number of Participants Who Achieved Normalization for OABSS Total Score Week 16	18 Participants	16 Participants	27 Participants	48 Participants
Number of Participants Who Achieved Normalization for OABSS Total Score Week 16 (LOCF)	19 Participants	16 Participants	29 Participants	49 Participants

SECONDARY outcome

Timeframe: Baseline and week 8, 16

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score Week 8	-19.46 units on a scale Standard Deviation 16.735	-12.52 units on a scale Standard Deviation 20.926	-15.29 units on a scale Standard Deviation 14.348	-10.39 units on a scale Standard Deviation 17.222
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score Week 16	-21.00 units on a scale Standard Deviation 19.557	-22.25 units on a scale Standard Deviation 20.877	-17.68 units on a scale Standard Deviation 15.930	-16.56 units on a scale Standard Deviation 18.171
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score Week 16 (LOCF)	-21.21 units on a scale Standard Deviation 18.631	-22.25 units on a scale Standard Deviation 20.877	-17.55 units on a scale Standard Deviation 16.253	-16.31 units on a scale Standard Deviation 18.034

SECONDARY outcome

Timeframe: Baseline and week 8, 16

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in OAB-q SF Total HRQL Score Week 8	15.14 units on a scale Standard Deviation 12.786	9.31 units on a scale Standard Deviation 15.559	12.43 units on a scale Standard Deviation 15.449	6.14 units on a scale Standard Deviation 13.797
Change From Baseline in OAB-q SF Total HRQL Score Week 16	17.54 units on a scale Standard Deviation 13.349	16.72 units on a scale Standard Deviation 16.439	14.72 units on a scale Standard Deviation 16.428	12.72 units on a scale Standard Deviation 17.170
Change From Baseline in OAB-q SF Total HRQL Score Week 16 (LOCF)	17.34 units on a scale Standard Deviation 13.005	16.72 units on a scale Standard Deviation 16.439	13.88 units on a scale Standard Deviation 16.080	12.56 units on a scale Standard Deviation 17.022

SECONDARY outcome

Timeframe: Baseline and week 4, 8, 12, 16

Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in the Number of Micturitions Per 24 Hours Week 12	-1.98 micturitions Standard Deviation 1.667	-2.40 micturitions Standard Deviation 1.997	-1.50 micturitions Standard Deviation 1.850	-1.75 micturitions Standard Deviation 2.136
Change From Baseline in the Number of Micturitions Per 24 Hours Week 4	-0.34 micturitions Standard Deviation 1.576	-0.98 micturitions Standard Deviation 1.977	-1.33 micturitions Standard Deviation 1.604	-1.02 micturitions Standard Deviation 1.666
Change From Baseline in the Number of Micturitions Per 24 Hours Week 8	-1.69 micturitions Standard Deviation 1.690	-1.31 micturitions Standard Deviation 1.862	-1.74 micturitions Standard Deviation 1.586	-1.32 micturitions Standard Deviation 1.656
Change From Baseline in the Number of Micturitions Per 24 Hours Week 16	-2.06 micturitions Standard Deviation 1.677	-2.36 micturitions Standard Deviation 2.106	-1.90 micturitions Standard Deviation 1.920	-2.13 micturitions Standard Deviation 2.118
Change From Baseline in the Number of Micturitions Per 24 Hours Week 16 (LOCF)	-1.89 micturitions Standard Deviation 1.789	-2.36 micturitions Standard Deviation 2.106	-1.94 micturitions Standard Deviation 1.792	-2.12 micturitions Standard Deviation 2.094

SECONDARY outcome

Timeframe: Week 16

Normalization for the mean number of micturitions per 24 hours was defined as \< 8 micturitions per 24 hours.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours	10 Participants	17 Participants	23 Participants	40 Participants

SECONDARY outcome

Timeframe: Baseline and week 4, 8, 12, 16

Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=30 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=36 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=49 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=90 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in the Number of Urgency Episodes Per 24 Hours Week 4	-1.15 urgency episodes Standard Deviation 1.843	-1.26 urgency episodes Standard Deviation 1.927	-1.45 urgency episodes Standard Deviation 1.790	-1.43 urgency episodes Standard Deviation 2.057
Change From Baseline in the Number of Urgency Episodes Per 24 Hours Week 8	-1.77 urgency episodes Standard Deviation 0.969	-1.49 urgency episodes Standard Deviation 1.897	-1.76 urgency episodes Standard Deviation 1.490	-1.37 urgency episodes Standard Deviation 2.189
Change From Baseline in the Number of Urgency Episodes Per 24 Hours Week 12	-1.95 urgency episodes Standard Deviation 1.279	-2.55 urgency episodes Standard Deviation 2.162	-1.89 urgency episodes Standard Deviation 1.674	-1.88 urgency episodes Standard Deviation 2.576
Change From Baseline in the Number of Urgency Episodes Per 24 Hours Week 16	-1.77 urgency episodes Standard Deviation 1.253	-2.59 urgency episodes Standard Deviation 2.201	-1.93 urgency episodes Standard Deviation 1.759	-2.06 urgency episodes Standard Deviation 2.419
Change From Baseline in the Number of Urgency Episodes Per 24 Hours Week 16 (LOCF)	-1.57 urgency episodes Standard Deviation 1.382	-2.59 urgency episodes Standard Deviation 2.201	-1.93 urgency episodes Standard Deviation 1.877	-2.02 urgency episodes Standard Deviation 2.392

SECONDARY outcome

Timeframe: Week 16

Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours	16 Participants	13 Participants	31 Participants	38 Participants

SECONDARY outcome

Timeframe: Baseline and week 4, 8, 12, 16

Participants completed the patient diary (paper document) for 3 days immediately before each visit. 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 by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=14 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=28 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=29 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=60 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Week 8	-1.06 incontinence episodes Standard Deviation 0.983	-0.73 incontinence episodes Standard Deviation 0.842	-1.26 incontinence episodes Standard Deviation 1.453	-0.76 incontinence episodes Standard Deviation 1.273
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Week 12	-1.31 incontinence episodes Standard Deviation 1.236	-1.04 incontinence episodes Standard Deviation 1.177	-1.03 incontinence episodes Standard Deviation 1.238	-0.93 incontinence episodes Standard Deviation 1.248
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Week 4	-0.85 incontinence episodes Standard Deviation 0.675	-0.55 incontinence episodes Standard Deviation 0.787	-1.12 incontinence episodes Standard Deviation 1.141	-0.64 incontinence episodes Standard Deviation 1.032
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Week 16	-1.22 incontinence episodes Standard Deviation 1.076	-1.08 incontinence episodes Standard Deviation 1.168	-1.32 incontinence episodes Standard Deviation 1.517	-1.08 incontinence episodes Standard Deviation 1.068
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Week 16 (LOCF)	-1.07 incontinence episodes Standard Deviation 1.064	-1.08 incontinence episodes Standard Deviation 1.168	-1.32 incontinence episodes Standard Deviation 1.505	-1.06 incontinence episodes Standard Deviation 1.055

SECONDARY outcome

Timeframe: Week 16

Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours	10 Participants	21 Participants	19 Participants	46 Participants

SECONDARY outcome

Timeframe: Baseline and week 4, 8, 12, 16

Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=11 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=28 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=26 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=52 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours Week 12	-1.30 urge incontinence episodes Standard Deviation 1.252	-0.94 urge incontinence episodes Standard Deviation 1.115	-0.84 urge incontinence episodes Standard Deviation 0.996	-0.91 urge incontinence episodes Standard Deviation 1.160
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours Week 4	-0.87 urge incontinence episodes Standard Deviation 0.689	-0.50 urge incontinence episodes Standard Deviation 0.756	-0.77 urge incontinence episodes Standard Deviation 1.220	-0.82 urge incontinence episodes Standard Deviation 1.055
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours Week 8	-1.17 urge incontinence episodes Standard Deviation 1.045	-0.65 urge incontinence episodes Standard Deviation 0.793	-1.07 urge incontinence episodes Standard Deviation 1.068	-0.72 urge incontinence episodes Standard Deviation 1.208
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours Week 16	-1.07 urge incontinence episodes Standard Deviation 0.940	-1.00 urge incontinence episodes Standard Deviation 1.089	-1.11 urge incontinence episodes Standard Deviation 1.089	-0.96 urge incontinence episodes Standard Deviation 1.040
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours Week 16 (LOCF)	-0.97 urge incontinence episodes Standard Deviation 0.948	-1.00 urge incontinence episodes Standard Deviation 1.089	-1.04 urge incontinence episodes Standard Deviation 1.412	-0.94 urge incontinence episodes Standard Deviation 1.027

SECONDARY outcome

Timeframe: Baseline and week 8, 16

Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was \> 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was \> 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was \> 0 at baseline was included in the analysis.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=33 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=55 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in the Volume Voided Per Micturition Week 8	22.120 mL Standard Deviation 26.2220	19.380 mL Standard Deviation 31.5492	33.781 mL Standard Deviation 32.6029	24.821 mL Standard Deviation 35.8941
Change From Baseline in the Volume Voided Per Micturition Week16	28.532 mL Standard Deviation 32.2243	33.031 mL Standard Deviation 38.2492	35.780 mL Standard Deviation 33.8236	36.921 mL Standard Deviation 43.8896
Change From Baseline in the Volume Voided Per Micturition Week 16 (LOCF)	29.865 mL Standard Deviation 32.5400	33.031 mL Standard Deviation 38.2492	34.118 mL Standard Deviation 32.6790	36.957 mL Standard Deviation 43.6344

SECONDARY outcome

Timeframe: Baseline and week 4, 8, 12, 16

Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=28 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=29 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=50 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=81 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in the Number of Nocturia Episodes Per Night Week 4	0.17 nocturia episodes Standard Deviation 1,122	-0.07 nocturia episodes Standard Deviation 0.787	-0.45 nocturia episodes Standard Deviation 0.709	-0.27 nocturia episodes Standard Deviation 0.738
Change From Baseline in the Number of Nocturia Episodes Per Night Week 8	-0.38 nocturia episodes Standard Deviation 0.681	-0.21 nocturia episodes Standard Deviation 0.688	-0.37 nocturia episodes Standard Deviation 0.682	-0.44 nocturia episodes Standard Deviation 0.825
Change From Baseline in the Number of Nocturia Episodes Per Night Week 12	-0.35 nocturia episodes Standard Deviation 0.704	-0.48 nocturia episodes Standard Deviation 0.796	-0.29 nocturia episodes Standard Deviation 0.829	-0.58 nocturia episodes Standard Deviation 0.916
Change From Baseline in the Number of Nocturia Episodes Per Night Week 16	-0.38 nocturia episodes Standard Deviation 0.881	-0.31 nocturia episodes Standard Deviation 0.674	-0.44 nocturia episodes Standard Deviation 0.813	-0.61 nocturia episodes Standard Deviation 0.992
Change From Baseline in the Number of Nocturia Episodes Per Night Week 16 (LOCF)	-0.43 nocturia episodes Standard Deviation 0.847	-0.31 nocturia episodes Standard Deviation 0.674	-0.44 nocturia episodes Standard Deviation 0.812	-0.60 nocturia episodes Standard Deviation 0.982

SECONDARY outcome

Timeframe: Baseline and week 4, 8, 12, 16

Population: SAF

Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.

Outcome measures

Outcome measures
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=35 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 Participants Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=58 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 Participants Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Change From Baseline in Postvoid Residual (PVR) Volume Week 4	-4.95 mL Standard Deviation 18.078	5.88 mL Standard Deviation 17.709	13.78 mL Standard Deviation 35.702	4.36 mL Standard Deviation 20.797
Change From Baseline in Postvoid Residual (PVR) Volume Week 8	-2.83 mL Standard Deviation 19.442	5.07 mL Standard Deviation 19.512	11.05 mL Standard Deviation 32.310	1.87 mL Standard Deviation 13.428
Change From Baseline in Postvoid Residual (PVR) Volume Week 12	-2.53 mL Standard Deviation 21.047	5.29 mL Standard Deviation 22.163	6.51 mL Standard Deviation 22.067	1.17 mL Standard Deviation 17.997
Change From Baseline in Postvoid Residual (PVR) Volume Week 16	0.63 mL Standard Deviation 24.102	3.96 mL Standard Deviation 14.897	7.31 mL Standard Deviation 22.754	3.60 mL Standard Deviation 24.223
Change From Baseline in Postvoid Residual (PVR) Volume Week 16 (LOCF)	-0.42 mL Standard Deviation 23.576	3.96 mL Standard Deviation 14.897	8.00 mL Standard Deviation 28.833	3.17 mL Standard Deviation 24.144

Adverse Events

Solifenacin 2.5 mg + Mirabegron 25 mg

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Solifenacin 2.5 mg + Mirabegron 50 mg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Solifenacin 5 mg + Mirabegron 25 mg

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Solifenacin 5 mg + Mirabegron 50 mg

Serious events: 4 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Solifenacin 2.5 mg + Mirabegron 25 mg n=35 participants at risk Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 2.5 mg + Mirabegron 50 mg n=37 participants at risk Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.	Solifenacin 5 mg + Mirabegron 25 mg n=58 participants at risk Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.	Solifenacin 5 mg + Mirabegron 50 mg n=93 participants at risk Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Cardiac disorders Atrial fibrillation	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.1% 1/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	2.7% 1/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Injury, poisoning and procedural complications Laceration	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.7% 1/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.7% 1/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	2.2% 2/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Investigations Blood pressure increased	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.7% 1/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Investigations Blood urea increased	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.7% 1/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Investigations ECG ST segment depression	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.7% 1/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	1.1% 1/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.
Skin and subcutaneous tissue disorders Urticaria	2.9% 1/35 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/37 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/58 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.	0.00% 0/93 • From first dose of study drug up to week 16 Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.

Other adverse events

Additional Information

Medical Director

Astellas Pharma Inc.

Phone: +81-3-3244-0512 Ext:

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.
Publication restrictions are in place

Restriction type: OTHER