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    Clinical Trial Results:
    A Randomized, Double-blind, Parallel-group, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

    Summary
    EudraCT number
    		 2012-005735-91
    Trial protocol
    		 GB   BE   DE   NL   CZ   HU   LV   SE   IT   EE   FI   SK   SI   DK   ES   LT   PL   GR   BG  
    Global end of trial date
    22 Oct 2015

    Results information
    Results version number
    		 v1
    This version publication date
    04 Nov 2016
    First version publication date
    04 Nov 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    178-CL-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01972841
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands, 2333 BE
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V., astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V., astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron (5 + 25 mg and 5 + 50 mg) compared to solifenacin (5 mg) and mirabegron (25 mg and 50 mg) monotherapy.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Australia: 56
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 116
    Country: Number of subjects enrolled
    Canada: 133
    Country: Number of subjects enrolled
    China: 118
    Country: Number of subjects enrolled
    Czech Republic: 184
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Estonia: 12
    Country: Number of subjects enrolled
    Finland: 6
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 159
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    Hungary: 114
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Latvia: 29
    Country: Number of subjects enrolled
    Lithuania: 55
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Mexico: 19
    Country: Number of subjects enrolled
    New Zealand: 16
    Country: Number of subjects enrolled
    Norway: 40
    Country: Number of subjects enrolled
    Peru: 14
    Country: Number of subjects enrolled
    Philippines: 20
    Country: Number of subjects enrolled
    Poland: 317
    Country: Number of subjects enrolled
    Romania: 68
    Country: Number of subjects enrolled
    Russian Federation: 108
    Country: Number of subjects enrolled
    Singapore: 17
    Country: Number of subjects enrolled
    Slovakia: 158
    Country: Number of subjects enrolled
    Slovenia: 6
    Country: Number of subjects enrolled
    South Africa: 36
    Country: Number of subjects enrolled
    Korea, Republic of: 211
    Country: Number of subjects enrolled
    Spain: 48
    Country: Number of subjects enrolled
    Sweden: 79
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    Thailand: 50
    Country: Number of subjects enrolled
    Turkey: 5
    Country: Number of subjects enrolled
    Ukraine: 325
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    United States: 873
    Country: Number of subjects enrolled
    Netherlands: 31
    Worldwide total number of subjects
    3527
    EEA total number of subjects
    1501
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2383
    From 65 to 84 years
    1134
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who had symptoms of “wet” overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 435 centers globally. Eligible participants went into a single-blind, 4-week placebo run-in period and completed a micturition diary 7 days prior to each study visit.

    Pre-assignment
    Screening details
    		 A total of 6991 participants were screened, 6275 participants received placebo run-in treatment and 3527 participants were randomized into 1 of 6 treatment arms in a 1:1:1:1:2:2 ratio in the 12-week double-blind treatment period. A total of 953 participants were also enrolled in an ambulatory blood pressure monitoring (ABPM) substudy.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants who received matching placebo once a day for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to solifenacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day.

    Investigational medicinal product name
    Placebo to mirabegron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo to match mirabegron 25 mg or 50 mg orally once a day at the same time each day.

    Arm title
    		 Mirabegron 25 mg
    Arm description
    		 Participants who received mirabegron 25 mg once a day for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq, Myrbetric, Betanis, Betmiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received mirabegron 25 mg orally once a day at the same time each day.

    Arm title
    		 Mirabegron 50 mg
    Arm description
    		 Participants who received mirabegron 50 mg once a day for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq, Myrbetric, Betanis, Betmiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received mirabegron 50 mg orally once a day at the same time each day.

    Arm title
    		 Solifenacin 5 mg
    Arm description
    		 Participants who received solifenacin 5 mg once a day for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    Solifenacin, Vesicare, Vesikur, Vesitrim
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received solifenacin succinate 5 mg orally once a day at the same time each day.

    Arm title
    		 Solifenacin 5 mg + mirabegron 25 mg
    Arm description
    		 Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    Solifenacin, Vesicare, Vesikur, Vesitrim
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received solifenacin succinate 5 mg orally once a day at the same time each day.

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq, Myrbetric, Betanis, Betmiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received mirabegron 25 mg orally once a day at the same time each day.

    Arm title
    		 Solifenacin 5 mg + mirabegron 50 mg
    Arm description
    		 Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    Solifenacin, Vesicare, Vesikur, Vesitrim
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received solifenacin succinate 5 mg orally once a day at the same time each day.

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq, Myrbetric, Betanis, Betmiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received mirabegron 50 mg orally once a day at the same time each day.

    Number of subjects in period 1
    		Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Started
    447
    441
    437
    434
    885
    883
    Treated
    444
    436
    433
    432
    878
    871
    Safety Analysis Set (SAF)
    429
    423
    422
    423
    853
    848
    Full Analysis Set (FAS)
    418
    410
    411
    415
    827
    827
    Completed
    404
    397
    387
    397
    802
    798
    Not completed
    43
    44
    50
    37
    83
    85
         Randomized but never received double-blind tdrug
    2
    5
    4
    2
    6
    13
         Protocol violation
    2
    2
    3
    5
    9
    4
         Did not have a treatment page
    -
    -
    -
    -
    1
    -
         Miscellaneous
    -
    -
    4
    1
    -
    4
         Adverse event
    13
    8
    12
    9
    21
    26
         Lost to follow-up
    4
    2
    4
    2
    9
    3
         Lack of efficacy
    1
    -
    -
    2
    4
    1
         Withdrawal by patient
    21
    27
    23
    16
    33
    34

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received matching placebo once a day for 12 weeks.

    Reporting group title
    Mirabegron 25 mg
    Reporting group description
    		 Participants who received mirabegron 25 mg once a day for 12 weeks.

    Reporting group title
    Mirabegron 50 mg
    Reporting group description
    		 Participants who received mirabegron 50 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 25 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 50 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

    Reporting group values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg Total
    Number of subjects
    		 447 441 437 434 885 883
    Age categorical
    Units: Subjects
    Age continuous
    Randomized analysis set (RAS), comprised of all randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    		 57.46 ( 13.2 ) 56.77 ( 13.46 ) 56.69 ( 13.28 ) 57.88 ( 12.92 ) 56.94 ( 13.78 ) 57.3 ( 13.46 ) -
    Gender categorical
    RAS
    Units:
        Male
    		 102 98 99 92 199 199 789
        Female
    		 345 343 338 342 686 684 2738
    Mean Number of Incontinence Episodes per 24 Hours
    RAS; data only available for 3490 participants [444, 434, 433, 432, 877, 870].
    Units: incontinence episodes
        arithmetic mean (standard deviation)
    		 3.32 ( 3.32 ) 3.33 ( 3.36 ) 3.16 ( 3.44 ) 3.56 ( 3.51 ) 3.15 ( 3.15 ) 3.11 ( 3.05 ) -
    Mean Number of Micturitions per 24 Hours
    RAS; data only available for 3490 participants [444, 434, 433, 432, 877, 870].
    Units: micturitions
        arithmetic mean (standard deviation)
    		 10.9 ( 2.81 ) 10.79 ( 2.61 ) 11.14 ( 3.22 ) 10.77 ( 2.64 ) 10.72 ( 2.85 ) 10.74 ( 2.35 ) -
    Mean Volume Voided per Micturition
    RAS; data only available for 3475 participants [440, 433, 431, 430, 873, 868].
    Units: mL
        arithmetic mean (standard deviation)
    		 157.53 ( 58.53 ) 151.79 ( 60.39 ) 155.36 ( 59.7 ) 152.09 ( 59.57 ) 159.47 ( 58.15 ) 153.74 ( 59.38 ) -
    Number of Incontinence Episodes per Week
    RAS; data only available for 3490 participants [444, 434, 433, 432, 877, 870].
    Units: incontinence episodes
        arithmetic mean (standard deviation)
    		 22.99 ( 23.2 ) 22.85 ( 23.31 ) 21.58 ( 23.53 ) 24.64 ( 24.46 ) 21.57 ( 21.6 ) 21.41 ( 21.1 ) -
    Mean Number of Urgency Incontinence Episodes per 24 Hours
    RAS; data only available for 3469 participants [441, 432, 427, 431, 872, 866]. Only participants with ≥ 1 urgency incontinence episode at baseline were included.
    Units: urgency incontinence episodes
        arithmetic mean (standard deviation)
    		 3.07 ( 3.18 ) 2.92 ( 3.05 ) 2.88 ( 3.28 ) 3.21 ( 3.32 ) 2.79 ( 2.8 ) 2.76 ( 2.63 ) -
    Number of Urgency Incontinence Episodes per Week
    RAS; data only available for 3469 participants [441, 432, 427, 431, 872, 866]. Only participants with ≥ 1 urgency incontinence episode at baseline were included.
    Units: urgency incontinence episodes
        arithmetic mean (standard deviation)
    		 21.25 ( 22.2 ) 20.03 ( 21.09 ) 19.73 ( 22.43 ) 22.23 ( 23.19 ) 19.15 ( 19.26 ) 18.99 ( 18.11 ) -
    Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours
    RAS; data only available for 3488 participants [442, 434, 433, 432, 876, 870]. Only participants with ≥ 1 urgency episode at baseline were included.
    Units: urgency episodes
        arithmetic mean (standard deviation)
    		 6.66 ( 4.02 ) 6.35 ( 3.88 ) 6.58 ( 4.83 ) 6.6 ( 3.87 ) 6.34 ( 3.72 ) 6.33 ( 3.59 ) -
    Mean Number of Nocturia Episodes per 24 Hours
    RAS; data only available for 3002 participants [393, 366, 377, 367, 754, 745]. Only participants with ≥ 1 nocturia episode at baseline were included.
    Units: nocturia episdes
        arithmetic mean (standard deviation)
    		 1.57 ( 1.04 ) 1.53 ( 1.01 ) 1.59 ( 1.08 ) 1.61 ( 0.95 ) 1.57 ( 1.06 ) 1.54 ( 0.97 ) -
    Number of Nocturia Episodes per Week
    RAS; data only available for 3002 participants [393, 366, 377, 367, 754, 745]. Only participants with ≥ 1 nocturia episode at baseline were included.
    Units: nocturia episodes
        arithmetic mean (standard deviation)
    		 10.83 ( 7.26 ) 10.57 ( 7.06 ) 10.98 ( 7.52 ) 11.13 ( 6.6 ) 10.82 ( 7.38 ) 10.62 ( 6.74 ) -
    Mean Number of Pads Used per 24 Hours
    RAS; data only available for 2203 participants [281, 272, 270, 278, 554, 548]. Only participants with ≥ 1 pad used at baseline were included.
    Units: pads
        arithmetic mean (standard deviation)
    		 2.79 ( 2.91 ) 2.74 ( 2.63 ) 2.56 ( 3.11 ) 2.84 ( 3.08 ) 2.44 ( 2.56 ) 2.55 ( 2.37 ) -
    Number of Pads Used per Week
    RAS; data only available for 2203 participants [281, 272, 270, 278, 554, 548]. Only participants with ≥ 1 pad used at baseline were included.
    Units: pads
        arithmetic mean (standard deviation)
    		 19.29 ( 20.38 ) 18.78 ( 18.21 ) 17.5 ( 21.17 ) 19.62 ( 21.39 ) 16.72 ( 17.58 ) 17.5 ( 16.34 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received matching placebo once a day for 12 weeks.

    Reporting group title
    Mirabegron 25 mg
    Reporting group description
    		 Participants who received mirabegron 25 mg once a day for 12 weeks.

    Reporting group title
    Mirabegron 50 mg
    Reporting group description
    		 Participants who received mirabegron 50 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 25 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 50 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

    Primary: Change from Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes per 24 Hours

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    End point title
    		 Change from Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes per 24 Hours
    End point description
    An incontinence episode is defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. The analysis population was the Full Analysis Set (FAS), which was comprised of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from site 10153. Last observation carried forward (LOCF) for EoT was used.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    412
    409
    406
    413
    823
    816
    Units: incontinence episodes
        least squares mean (standard error)
    -1.34 ( 0.1 )
    -1.7 ( 0.1 )
    -1.76 ( 0.1 )
    -1.79 ( 0.1 )
    -2.04 ( 0.07 )
    -1.98 ( 0.07 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.072 [2]
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [1] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [2] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.033
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [3] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.001 [5]
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.58
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [4] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [5] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1222
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.052
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [6] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.

    Primary: Change from Baseline to EoT in Mean Number of Micturitions per 24 Hours

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    End point title
    		 Change from Baseline to EoT in Mean Number of Micturitions per 24 Hours
    End point description
    A micturition is defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    412
    409
    406
    413
    823
    816
    Units: micturitions
        least squares mean (standard error)
    -1.64 ( 0.12 )
    -2 ( 0.12 )
    -2.03 ( 0.12 )
    -2.2 ( 0.12 )
    -2.49 ( 0.08 )
    -2.59 ( 0.08 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.04 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [7] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [8] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.006 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [9] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [10] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.001 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 -0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [11] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [12] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1222
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 < 0.001 [14]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 -0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [13] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [14] - Nominal p-value

    Secondary: Change from Baseline to EoT in Mean Volume Voided per Micturition

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    End point title
    		 Change from Baseline to EoT in Mean Volume Voided per Micturition
    End point description
    The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    413
    407
    408
    411
    821
    821
    Units: mL
        least squares mean (standard error)
    8.44 ( 2.55 )
    13.32 ( 2.57 )
    21.99 ( 2.57 )
    30.99 ( 2.56 )
    34.84 ( 1.81 )
    39.73 ( 1.81 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.219 [16]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    3.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.29
         upper limit
    		 10
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.13
    Notes
    [15] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [16] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.005 [18]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    8.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.61
         upper limit
    		 14.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.13
    Notes
    [17] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [18] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1228
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 < 0.001 [20]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    21.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.35
         upper limit
    		 27.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.14
    Notes
    [19] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [20] - Nominal p-value
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 < 0.001 [22]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    17.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.58
         upper limit
    		 23.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.14
    Notes
    [21] - Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure. No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.
    [22] - Nominal p-value

    Secondary: Change from Baseline to EoT in OAB Questionnaire (OAB-q) Symptom Bother Score

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    End point title
    		 Change from Baseline to EoT in OAB Questionnaire (OAB-q) Symptom Bother Score
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    400
    392
    398
    399
    800
    795
    Units: units on a scale
        least squares mean (standard error)
    -19.45 ( 0.98 )
    -23.93 ( 0.99 )
    -26.14 ( 0.98 )
    -26.44 ( 0.98 )
    -31.06 ( 0.69 )
    -32.24 ( 0.7 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -4.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.98
         upper limit
    		 -2.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [23] - No adjustment for multiplicity was made for this comparison.
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.17
         upper limit
    		 -3.44
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.21
    Notes
    [24] - No adjustment for multiplicity was made for this comparison.
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1192
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -7.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 -4.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.21
    Notes
    [25] - No adjustment for multiplicity was made for this comparison.
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [26]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.46
         upper limit
    		 -3.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [26] - No adjustment for multiplicity was made for this comparison.

    Secondary: Change from Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

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    End point title
    		 Change from Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
    End point description
    The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicates improvement. The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    399
    391
    398
    399
    798
    794
    Units: units on a scale
        least squares mean (standard error)
    1.42 ( 0.11 )
    2.16 ( 0.11 )
    2.18 ( 0.11 )
    2.28 ( 0.11 )
    2.53 ( 0.08 )
    2.55 ( 0.08 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    P-value
    		 = 0.077 [28]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [27] - No adjustment for multiplicity was made for this comparison.
    [28] - P < 0.05 indicates statistical significance at the 0.05 level.
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    P-value
    		 = 0.05 [30]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [29] - No adjustment for multiplicity was made for this comparison.
    [30] - P < 0.05 indicates statistical significance at the 0.05 level.
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [31]
    P-value
    		 = 0.008 [32]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [31] - No adjustment for multiplicity was made for this comparison.
    [32] - P < 0.05 indicates statistical significance at the 0.05 level.
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1192
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [33]
    P-value
    		 = 0.007 [34]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [33] - No adjustment for multiplicity was made for this comparison.
    [34] - P < 0.05 indicates statistical significance at the 0.05 level.

    Secondary: Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT

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    End point title
    		 Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
    End point description
    The number of incontinence episodes is the number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: incontinence episodes
    least squares mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    18.09 ( 1.17 )
    15.65 ( 1.08 )
    12.9 ( 1.06 )
    15.31 ( 1.11 )
    12.51 ( 0.67 )
    11.44 ( 0.7 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    14.45 ( 1.12 )
    12.84 ( 1.05 )
    11.31 ( 1.09 )
    12.19 ( 1.06 )
    9.7 ( 0.65 )
    9.33 ( 0.68 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    14.06 ( 1.17 )
    10.6 ( 0.98 )
    9.5 ( 0.98 )
    11.25 ( 1.03 )
    7.62 ( 0.57 )
    8.21 ( 0.68 )
        Eot [N=412, 409, 406, 413, 823, 816]
    13.7 ( 1.08 )
    11.19 ( 0.95 )
    9.79 ( 0.94 )
    11.21 ( 0.98 )
    8.02 ( 0.55 )
    8.18 ( 0.64 )
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.135
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.282
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Statistical analysis title
    		 Rate ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Statistical analysis title
    		 Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.172
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    823
    816
    Units: incontinence episodes
    least squares mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    -5.23 ( 0.66 )
    -7.59 ( 0.66 )
    -8.99 ( 0.67 )
    -8.92 ( 0.67 )
    -9.62 ( 0.47 )
    -10.51 ( 0.47 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    -8.79 ( 0.71 )
    -10.57 ( 0.72 )
    -10.97 ( 0.72 )
    -11.89 ( 0.72 )
    -12.53 ( 0.5 )
    -12.78 ( 0.51 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    -9.05 ( 0.72 )
    -12.33 ( 0.72 )
    -12.58 ( 0.72 )
    -12.75 ( 0.71 )
    -14.5 ( 0.51 )
    -13.94 ( 0.51 )
        EoT [N=412, 409, 406, 413, 823, 816]
    -9.42 ( 0.68 )
    -11.93 ( 0.68 )
    -12.39 ( 0.68 )
    -12.65 ( 0.68 )
    -14.29 ( 0.48 )
    -13.98 ( 0.48 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.074
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    -1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.27
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.96
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 least square mean difference
    Point estimate
    -2.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 -0.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1227
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.024
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.23
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.84

    Secondary: Change from Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes per 24 Hours

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    End point title
    		 Change from Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes per 24 Hours
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: incontinence episodes
    least squares mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    -0.74 ( 0.1 )
    -1.07 ( 0.1 )
    -1.24 ( 0.1 )
    -1.24 ( 0.1 )
    -1.38 ( 0.07 )
    -1.5 ( 0.07 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    -1.2 ( 0.1 )
    -1.51 ( 0.1 )
    -1.57 ( 0.1 )
    -1.66 ( 0.1 )
    -1.79 ( 0.07 )
    -1.84 ( 0.07 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    -1.3 ( 0.11 )
    -1.76 ( 0.11 )
    -1.81 ( 0.11 )
    -1.8 ( 0.1 )
    -2.08 ( 0.07 )
    -1.98 ( 0.07 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions per 24 Hours

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    End point title
    		 Change from Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions per 24 Hours
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: micturitions
    least squares mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    -1.02 ( 0.11 )
    -1.46 ( 0.11 )
    -1.44 ( 0.11 )
    -1.39 ( 0.11 )
    -1.67 ( 0.08 )
    -1.91 ( 0.08 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    -1.43 ( 0.11 )
    -1.95 ( 0.12 )
    -1.89 ( 0.12 )
    -1.84 ( 0.12 )
    -2.23 ( 0.08 )
    -2.42 ( 0.08 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    -1.51 ( 0.12 )
    -2.01 ( 0.12 )
    -2.03 ( 0.12 )
    -2.22 ( 0.12 )
    -2.47 ( 0.08 )
    -2.6 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 8 and 12 in Mean Volume Voided per Micturition

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    End point title
    		 Change from Baseline to Weeks 4, 8 and 12 in Mean Volume Voided per Micturition
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: mL
    least squares mean (standard error)
        Week 4 [N=403, 398, 399, 395, 798, 802]
    6.95 ( 2.13 )
    10.08 ( 2.14 )
    15.52 ( 2.14 )
    24.23 ( 2.15 )
    25.54 ( 1.51 )
    28.99 ( 1.51 )
        Week 8 [N=395, 382, 380, 387, 770, 771]
    9 ( 2.48 )
    10.96 ( 2.52 )
    17.73 ( 2.53 )
    27.55 ( 2.5 )
    32.94 ( 1.78 )
    36.51 ( 1.77 )
        Week 12 [N=373, 362, 364, 378, 750, 750]
    8.7 ( 2.7 )
    12.88 ( 2.74 )
    22.4 ( 2.73 )
    31.89 ( 2.68 )
    35.52 ( 1.9 )
    41.28 ( 1.9 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to EoT in Corrected Micturition Frequency

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    End point title
    		 Change from Baseline to EoT in Corrected Micturition Frequency
    End point description
    Corrected micturition frequency is defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    412
    409
    406
    413
    823
    816
    Units: micturitions
        least squares mean (standard error)
    0.15 ( 0.24 )
    -0.17 ( 0.24 )
    -0.97 ( 0.24 )
    -1.28 ( 0.24 )
    -1.1 ( 0.17 )
    -1.52 ( 0.17 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 0.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.413
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1222
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean diffrence
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.13
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3

    Secondary: Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EOT

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    End point title
    		 Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EOT
    End point description
    An urgency incontinence episode is defined as the involuntary leakage of urine accompanied by or immediately proceeded by urgency. The number of urgency incontinence episodes is number of times a participant records an urgency incontinence episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: urgency incontinence episodes
    least squares mean (standard error)
        Week 4 [N=403, 404, 396, 401, 813, 806]
    15.76 ( 1.1 )
    13.36 ( 0.99 )
    11.46 ( 1 )
    13.19 ( 1.06 )
    10.22 ( 0.58 )
    9.33 ( 0.58 )
        Week 8 [N=394, 383, 380, 385, 780, 765]
    12.77 ( 1.07 )
    10.65 ( 0.94 )
    10.09 ( 1.02 )
    10.41 ( 1 )
    7.58 ( 0.53 )
    7.31 ( 0.54 )
        Week 12 [N=371, 367, 363, 378, 750, 746]
    12 ( 1.09 )
    8.84 ( 0.89 )
    8.32 ( 0.94 )
    9.29 ( 0.96 )
    5.86 ( 0.46 )
    6.27 ( 0.49 )
        EOT [N=409, 407, 400, 412, 819, 812]
    11.69 ( 1 )
    9.37 ( 0.86 )
    8.63 ( 0.89 )
    9.29 ( 0.91 )
    6.25 ( 0.45 )
    6.15 ( 0.47 )
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.288
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Rate ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: urgency incontinence episodes
    least squares mean (standard error)
        Week 4 [N=403, 404, 396, 401, 813, 806]
    -5.49 ( 0.63 )
    -7.07 ( 0.63 )
    -8.39 ( 0.63 )
    -8.53 ( 0.63 )
    -9.44 ( 0.44 )
    -10.23 ( 0.44 )
        Week 8 [N=394, 383, 380, 385, 780, 765]
    -8.3 ( 0.66 )
    -9.93 ( 0.67 )
    -10.07 ( 0.67 )
    -11.1 ( 0.67 )
    -12.18 ( 0.47 )
    -12.38 ( 0.47 )
        Week 12 [N=371, 367, 363, 378, 750, 746]
    -8.96 ( 0.65 )
    -11.39 ( 0.66 )
    -11.66 ( 0.66 )
    -12.1 ( 0.65 )
    -13.87 ( 0.46 )
    -13.53 ( 0.46 )
        EoT [N=409, 407, 400, 412, 819, 812]
    -9.26 ( 0.62 )
    -11.03 ( 0.62 )
    -11.44 ( 0.62 )
    -12.03 ( 0.62 )
    -13.64 ( 0.44 )
    -13.64 ( 0.44 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.114
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.09
         upper limit
    		 -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.76
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.76
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -2.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.09
         upper limit
    		 -1.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.76
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -2.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 -0.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.76

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes per 24 Hours

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes per 24 Hours
    End point description
    The mean number of urgency incontinence episodes was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: urgency incontinence episodes
    least squares mean (standard error)
        Week 4 [N=403, 404, 396, 401, 813, 806]
    -0.78 ( 0.09 )
    -1 ( 0.09 )
    -1.15 ( 0.09 )
    -1.19 ( 0.09 )
    -1.35 ( 0.06 )
    -1.47 ( 0.06 )
        Week 8 [N=394, 383, 380, 385, 780, 765]
    -1.15 ( 0.1 )
    -1.43 ( 0.1 )
    -1.44 ( 0.1 )
    -1.56 ( 0.1 )
    -1.74 ( 0.07 )
    -1.79 ( 0.07 )
        Week 12 [N=371, 367, 363, 378, 750, 746]
    -1.29 ( 0.1 )
    -1.63 ( 0.1 )
    -1.67 ( 0.1 )
    -1.72 ( 0.1 )
    -1.99 ( 0.07 )
    -1.93 ( 0.07 )
        EoT [N=409, 407, 400, 412, 819, 812]
    -1.33 ( 0.09 )
    -1.58 ( 0.09 )
    -1.62 ( 0.09 )
    -1.71 ( 0.09 )
    -1.95 ( 0.06 )
    -1.94 ( 0.06 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.134
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.043
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean diffeence
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours
    End point description
    An urgency episode is a complaint of a sudden, compelling desire to pass urine, which is difficult to defer; it is recorded when a micturition or incontinence episode is recorded and the severity of urinary urgency recorded is 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 urgency episode at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: urgency episodes
    least squares mean (standard error)
        Week 4 [N=405, 406, 402, 402, 817, 810]
    -1.34 ( 0.15 )
    -1.95 ( 0.14 )
    -1.91 ( 0.15 )
    -2.14 ( 0.15 )
    -2.42 ( 0.1 )
    -2.66 ( 0.1 )
        Week 8 [N=396, 385, 386, 386, 784, 769]
    -1.85 ( 0.15 )
    -2.54 ( 0.15 )
    -2.43 ( 0.15 )
    -2.9 ( 0.15 )
    -3.13 ( 0.11 )
    -3.28 ( 0.11 )
        Week 12 [N=373, 369, 369, 379, 754, 750]
    -2.05 ( 0.16 )
    -2.85 ( 0.16 )
    -2.7 ( 0.16 )
    -3.11 ( 0.16 )
    -3.45 ( 0.11 )
    -3.5 ( 0.11 )
        EoT [N=411, 409, 406, 413, 823, 816]
    -2.06 ( 0.15 )
    -2.74 ( 0.15 )
    -2.63 ( 0.15 )
    -3.05 ( 0.15 )
    -3.38 ( 0.11 )
    -3.51 ( 0.11 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.074
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 -0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 0.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19

    Secondary: Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT

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    End point title
    		 Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
    End point description
    A nocturia episode is defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patients gets up in the morning with the intention to stay awake). The number of nocturia episodes is the number of times a participant records a nocturia episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: nocturia episodes
    least squares mean (standard error)
        Week 4 [N=359, 341, 349, 341, 705, 693]
    9.62 ( 0.43 )
    8.46 ( 0.36 )
    9.11 ( 0.47 )
    9.22 ( 0.42 )
    8.4 ( 0.25 )
    8.09 ( 0.25 )
        Week 8 [N=349, 327, 336, 329, 676, 655]
    8.99 ( 0.44 )
    8.07 ( 0.34 )
    8.61 ( 0.45 )
    8.37 ( 0.38 )
    7.63 ( 0.25 )
    7.11 ( 0.24 )
        Week 12 [N=336, 312, 321, 320, 652, 641]
    8.91 ( 0.43 )
    7.99 ( 0.37 )
    8.34 ( 0.48 )
    8.17 ( 0.39 )
    7.26 ( 0.24 )
    6.67 ( 0.23 )
        EoT [N=363, 344, 353, 350, 708, 697]
    8.83 ( 0.42 )
    7.79 ( 0.35 )
    8.14 ( 0.45 )
    8.12 ( 0.37 )
    7.33 ( 0.24 )
    6.67 ( 0.22 )
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 0.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Rate ratio vs. Mirabgeron 25 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.049
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Rate ratio vs. Mirabgeron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 0.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: nocturia episodes
    least squares mean (standard error)
        Week 4 [N=359, 341, 349, 341, 705, 693]
    -1.27 ( 0.27 )
    -2.25 ( 0.28 )
    -1.8 ( 0.27 )
    -1.79 ( 0.28 )
    -2.39 ( 0.19 )
    -2.5 ( 0.19 )
        Week 8 [N=349, 327, 336, 329, 676, 655]
    -1.94 ( 0.27 )
    -2.7 ( 0.28 )
    -2.41 ( 0.28 )
    -2.6 ( 0.28 )
    -3.13 ( 0.2 )
    -3.48 ( 0.2 )
        Week 12 [N=336, 312, 321, 320, 652, 641]
    -1.95 ( 0.29 )
    -2.77 ( 0.3 )
    -2.73 ( 0.29 )
    -2.89 ( 0.29 )
    -3.49 ( 0.21 )
    -3.96 ( 0.21 )
        EoT [N=363, 344, 353, 350, 708, 697]
    -2.05 ( 0.27 )
    -2.91 ( 0.28 )
    -2.75 ( 0.28 )
    -2.81 ( 0.28 )
    -3.42 ( 0.2 )
    -3.96 ( 0.2 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.83
         upper limit
    		 -0.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 -0.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes per 24 Hours

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes per 24 Hours
    End point description
    The mean number of nocturia episodes was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: nocturia episodes
    least squares mean (standard error)
        Week 4 [N=359, 341, 349, 341, 705, 693]
    -0.17 ( 0.04 )
    -0.31 ( 0.04 )
    -0.25 ( 0.04 )
    -0.24 ( 0.04 )
    -0.33 ( 0.03 )
    -0.35 ( 0.03 )
        Week 8 [N=349, 327, 336, 329, 676, 655]
    -0.27 ( 0.04 )
    -0.37 ( 0.04 )
    -0.35 ( 0.04 )
    -0.36 ( 0.04 )
    -0.44 ( 0.03 )
    -0.5 ( 0.03 )
        Week 12 [N=336, 312, 321, 320, 652, 641]
    -0.26 ( 0.04 )
    -0.38 ( 0.04 )
    -0.39 ( 0.04 )
    -0.41 ( 0.04 )
    -0.49 ( 0.03 )
    -0.56 ( 0.03 )
        EoT [N=363, 344, 353, 350, 708, 697]
    -0.27 ( 0.04 )
    -0.4 ( 0.04 )
    -0.39 ( 0.04 )
    -0.39 ( 0.04 )
    -0.48 ( 0.03 )
    -0.56 ( 0.03 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 -0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 -0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05

    Secondary: Number of Pads Used at Weeks 4, 8, 12 and EoT

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    End point title
    		 Number of Pads Used at Weeks 4, 8, 12 and EoT
    End point description
    The number of pads used is the number of times a participant records a new pad used during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. Only participants with ≥ 1 pad used at baseline were included in the analysis. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: pads
    least squares mean (standard error)
        Week 4 [N=248, 250, 247, 257, 506, 499]
    15.62 ( 1.33 )
    13.46 ( 1.24 )
    10.05 ( 1.21 )
    11.41 ( 1.23 )
    9.71 ( 0.7 )
    9.34 ( 0.68 )
        Week 8 [N=239, 237, 240, 243, 485, 472]
    12.75 ( 1.22 )
    10.79 ( 1.05 )
    9.53 ( 1.39 )
    8.45 ( 1.03 )
    8.07 ( 0.65 )
    7.58 ( 0.62 )
        Week 12 [N=226, 225, 229, 241, 468, 461]
    12.62 ( 1.21 )
    9.65 ( 1 )
    8.44 ( 1.26 )
    8.21 ( 0.95 )
    6.6 ( 0.58 )
    6.64 ( 0.61 )
        EoT [N=252, 252, 249, 262, 510, 502]
    12.29 ( 1.11 )
    10.15 ( 0.97 )
    8.16 ( 1.17 )
    8.53 ( 0.94 )
    7.04 ( 0.56 )
    6.8 ( 0.59 )
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.938
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Statistical analysis title
    		 Rate ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.967
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Statistical analysis title
    		 Rate ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Statistical analysis title
    		 Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.069
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: pads
    least squares mean (standard error)
        Week 4 [N=248, 250, 247, 257, 506, 499]
    -3.69 ( 0.71 )
    -5.68 ( 0.71 )
    -7.83 ( 0.71 )
    -8.23 ( 0.7 )
    -7.61 ( 0.5 )
    -8.58 ( 0.5 )
        Week 8 [N=239, 237, 240, 243, 485, 472]
    -6.24 ( 0.77 )
    -8.44 ( 0.77 )
    -8.43 ( 0.76 )
    -10.67 ( 0.76 )
    -9.49 ( 0.54 )
    -10.59 ( 0.54 )
        Week 12 [N=226, 225, 229, 241, 468, 461]
    -6.29 ( 0.75 )
    -9.06 ( 0.75 )
    -9.41 ( 0.75 )
    -10.8 ( 0.73 )
    -10.66 ( 0.52 )
    -11.23 ( 0.53 )
        EoT [N=252, 252, 249, 262, 510, 502]
    -6.6 ( 0.71 )
    -8.76 ( 0.71 )
    -9.8 ( 0.72 )
    -10.63 ( 0.7 )
    -10.67 ( 0.5 )
    -11.21 ( 0.5 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.958
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.73
         upper limit
    		 1.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.86
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.27
         upper limit
    		 1.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.86
    Statistical analysis title
    		 Difference vs. Mirabgeron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.62
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.87
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.108
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.13
         upper limit
    		 0.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used per 24 Hours

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used per 24 Hours
    End point description
    The mean number of pads used was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 pads used at baseline were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: pads
    least squares mean (standard error)
        Week 4 [N=248, 250, 247, 257, 506, 499]
    -0.52 ( 0.1 )
    -0.81 ( 0.1 )
    -1.12 ( 0.1 )
    -1.19 ( 0.1 )
    -1.09 ( 0.07 )
    -1.23 ( 0.07 )
        Week 8 [N=239, 237, 240, 243, 485, 472]
    -0.82 ( 0.11 )
    -1.2 ( 0.11 )
    -1.24 ( 0.11 )
    -1.53 ( 0.11 )
    -1.36 ( 0.08 )
    -1.51 ( 0.08 )
        Week 12 [N=226, 225, 229, 241, 468, 461]
    -0.92 ( 0.11 )
    -1.3 ( 0.11 )
    -1.37 ( 0.11 )
    -1.56 ( 0.11 )
    -1.54 ( 0.08 )
    -1.59 ( 0.08 )
        EoT [N=252, 252, 249, 262, 510, 502]
    -0.94 ( 0.1 )
    -1.26 ( 0.1 )
    -1.41 ( 0.1 )
    -1.53 ( 0.1 )
    -1.53 ( 0.07 )
    -1.58 ( 0.07 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.993
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.65
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Secondary: Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT

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    End point title
    		 Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
    End point description
    The number of incontinence-free days is the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: incontinence-free days
    arithmetic mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    2.25 ( 0.13 )
    2.48 ( 0.13 )
    2.98 ( 0.13 )
    2.74 ( 0.14 )
    3.08 ( 0.1 )
    3.37 ( 0.1 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    2.92 ( 0.14 )
    3.17 ( 0.14 )
    3.63 ( 0.15 )
    3.31 ( 0.14 )
    3.88 ( 0.1 )
    4.01 ( 0.1 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    3.19 ( 0.15 )
    3.69 ( 0.15 )
    3.96 ( 0.15 )
    3.68 ( 0.14 )
    4.33 ( 0.1 )
    4.25 ( 0.1 )
        EoT [N=412, 409, 406, 413, 823, 816]
    3.16 ( 0.14 )
    3.51 ( 0.14 )
    3.89 ( 0.14 )
    3.61 ( 0.14 )
    4.2 ( 0.1 )
    4.23 ( 0.1 )
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.68
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.68
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 1.95
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.68

    Secondary: Number of Days with < 8 Micturitions at Weeks 4, 8, 12 and EoT

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    End point title
    		 Number of Days with < 8 Micturitions at Weeks 4, 8, 12 and EoT
    End point description
    The number of days with < 8 micturitions is the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: days
    arithmetic mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    1.49 ( 0.1 )
    1.74 ( 0.1 )
    1.55 ( 0.1 )
    1.86 ( 0.11 )
    2.07 ( 0.08 )
    2.11 ( 0.08 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    1.69 ( 0.1 )
    2.08 ( 0.12 )
    1.99 ( 0.11 )
    2.22 ( 0.12 )
    2.59 ( 0.09 )
    2.7 ( 0.09 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    1.76 ( 0.11 )
    2.31 ( 0.13 )
    2.25 ( 0.12 )
    2.49 ( 0.13 )
    2.87 ( 0.09 )
    2.95 ( 0.1 )
        EoT [N=412, 409, 406, 413, 823, 816]
    1.8 ( 0.11 )
    2.28 ( 0.12 )
    2.22 ( 0.12 )
    2.49 ( 0.12 )
    2.84 ( 0.09 )
    2.92 ( 0.09 )
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.5
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.59
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 1.77
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 1.84

    Secondary: Number of Incontinence-Free Days with < 8 micturitions per day at Weeks 4, 8 and 12 and EoT

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    End point title
    		 Number of Incontinence-Free Days with < 8 micturitions per day at Weeks 4, 8 and 12 and EoT
    End point description
    The number of incontinence-free days with < 8 micturitions per day is the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: days
    arithmetic mean (standard error)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    0.64 ( 0.07 )
    0.84 ( 0.08 )
    0.87 ( 0.08 )
    0.91 ( 0.08 )
    1.21 ( 0.07 )
    1.32 ( 0.07 )
        Week 8 [N=397, 385, 386, 386, 784, 769]
    0.85 ( 0.08 )
    1.2 ( 0.1 )
    1.23 ( 0.1 )
    1.31 ( 0.1 )
    1.75 ( 0.08 )
    1.89 ( 0.08 )
        Week 12 [N=374, 369, 369, 379, 754, 750]
    0.98 ( 0.09 )
    1.47 ( 0.11 )
    1.5 ( 0.11 )
    1.6 ( 0.11 )
    2.12 ( 0.09 )
    2.15 ( 0.09 )
        EoT [N=412, 409, 406, 413, 823, 816]
    1.01 ( 0.08 )
    1.4 ( 0.1 )
    1.47 ( 0.1 )
    1.59 ( 0.1 )
    2.04 ( 0.08 )
    2.12 ( 0.09 )
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.64
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 1.75
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.32
         upper limit
    		 2.06
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Overdispersed binomial regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.33
         upper limit
    		 2.07

    Secondary: Change from Baseline in Patient Perception of Bladder Condition Questionnaire (PPBC) at Weeks 4, 8 and 12 and EoT

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    End point title
    		 Change from Baseline in Patient Perception of Bladder Condition Questionnaire (PPBC) at Weeks 4, 8 and 12 and EoT
    End point description
    The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. The analysis population is FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 393, 394, 791, 791]
    -0.54 ( 0.06 )
    -0.72 ( 0.06 )
    -0.83 ( 0.06 )
    -0.81 ( 0.06 )
    -0.99 ( 0.04 )
    -1.07 ( 0.04 )
        Week 8 [N=381, 372, 380, 385, 758, 761]]
    -0.8 ( 0.06 )
    -1.07 ( 0.06 )
    -1.12 ( 0.06 )
    -1.18 ( 0.06 )
    -1.32 ( 0.04 )
    -1.48 ( 0.04 )
        Week 12 [N=371, 362, 366, 375, 739, 735]
    -0.95 ( 0.06 )
    -1.23 ( 0.06 )
    -1.34 ( 0.06 )
    -1.32 ( 0.06 )
    -1.57 ( 0.04 )
    -1.72 ( 0.04 )
        EoT [N=400, 393, 398, 399, 801, 795]
    -0.91 ( 0.06 )
    -1.18 ( 0.06 )
    -1.31 ( 0.06 )
    -1.27 ( 0.06 )
    -1.53 ( 0.04 )
    -1.66 ( 0.04 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07

    Secondary: Change from Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score

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    End point title
    		 Change from Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    -13.84 ( 0.92 )
    -17.05 ( 0.93 )
    -18.98 ( 0.93 )
    -19.53 ( 0.93 )
    -23.46 ( 0.65 )
    -25.19 ( 0.65 )
        Week 8 [N=381, 370, 380, 385, 757, 761]
    -17.35 ( 0.98 )
    -22.79 ( 0.99 )
    -23.54 ( 0.98 )
    -24.69 ( 0.97 )
    -29.1 ( 0.69 )
    -30.04 ( 0.69 )
        Week 12 [N=371, 362, 366, 374, 738, 734]
    -19.94 ( 1.01 )
    -24.44 ( 1.02 )
    -26.8 ( 1.02 )
    -26.72 ( 1.01 )
    -31.7 ( 0.72 )
    -33.15 ( 0.72 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQL) Total Score

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQL) Total Score
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1 -6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    10.16 ( 0.83 )
    13.54 ( 0.83 )
    15.28 ( 0.83 )
    14.78 ( 0.83 )
    17.46 ( 0.58 )
    17.95 ( 0.59 )
        Week 8 [N=381, 370, 380, 385, 757, 761]
    14.51 ( 0.88 )
    17.95 ( 0.89 )
    18.54 ( 0.88 )
    18.57 ( 0.88 )
    22.3 ( 0.62 )
    22.45 ( 0.62 )
        Week 12 [N=371, 362, 366, 374, 738, 734]
    15.76 ( 0.92 )
    19.59 ( 0.93 )
    21.48 ( 0.92 )
    20.54 ( 0.91 )
    24.63 ( 0.65 )
    24.93 ( 0.65 )
        EoT [N=400, 392, 398, 399, 800, 795]
    15.37 ( 0.88 )
    18.94 ( 0.89 )
    21 ( 0.89 )
    20.15 ( 0.89 )
    23.96 ( 0.63 )
    24.3 ( 0.63 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    3.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.69
         upper limit
    		 5.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.08
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.03
         upper limit
    		 6.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.09
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    5.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.88
         upper limit
    		 7.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.09
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 5.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.09

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Coping

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Coping
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    11.74 ( 0.99 )
    14.87 ( 1 )
    17.68 ( 1 )
    16.52 ( 1 )
    19.31 ( 0.7 )
    20.36 ( 0.7 )
        Week 8 [N=381, 370, 380, 385, 757, 761]
    16.13 ( 1.04 )
    20.64 ( 1.05 )
    21.52 ( 1.04 )
    21.69 ( 1.03 )
    25.49 ( 0.74 )
    25.85 ( 0.73 )
        Week 12 [N=371, 362, 366, 374, 738, 734]
    18.17 ( 1.09 )
    22.04 ( 1.1 )
    24.94 ( 1.1 )
    23.67 ( 1.09 )
    28.32 ( 0.77 )
    29.03 ( 0.78 )
        EoT [N=400, 392, 398, 399, 800, 795]
    17.73 ( 1.05 )
    21.28 ( 1.06 )
    24.32 ( 1.05 )
    23.25 ( 1.05 )
    27.37 ( 0.74 )
    28.12 ( 0.75 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 6.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.29
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Lest squares mean difference
    Point estimate
    4.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.34
         upper limit
    		 7.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.29
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    6.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.55
         upper limit
    		 8.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 6.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.29

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Concern

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Concern
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    11.24 ( 0.95 )
    15.89 ( 0.96 )
    17.39 ( 0.95 )
    17.18 ( 0.95 )
    20.48 ( 0.67 )
    21.09 ( 0.67 )
        Week 8 [N=381, 370, 380, 385, 757, 761]
    16.1 ( 0.99 )
    20.63 ( 1.01 )
    20.55 ( 1 )
    20.96 ( 0.99 )
    25.26 ( 0.71 )
    25.65 ( 0.7 )
        Week 12 [N=371, 362, 366, 374, 738, 734]
    17.53 ( 1.03 )
    22.37 ( 1.04 )
    23.62 ( 1.04 )
    23.19 ( 1.03 )
    27.53 ( 0.73 )
    28.24 ( 0.73 )
        EoT [N=400, 392, 398, 399, 800, 795]
    16.98 ( 1 )
    21.55 ( 1.01 )
    23.07 ( 1 )
    22.65 ( 1 )
    26.89 ( 0.71 )
    27.47 ( 0.71 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.84
         upper limit
    		 6.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.22
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.42
         upper limit
    		 7.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.22
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    5.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.93
         upper limit
    		 7.75
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.23
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.01
         upper limit
    		 6.81
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.22

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Sleep

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Sleep
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    9.28 ( 0.95 )
    12.7 ( 0.96 )
    13.8 ( 0.96 )
    13.08 ( 0.96 )
    15.97 ( 0.68 )
    16.66 ( 0.68 )
        Week 8 [N=381, 370, 380, 385, 757, 761]
    13.58 ( 1.03 )
    16.39 ( 1.05 )
    17.33 ( 1.03 )
    16.43 ( 1.03 )
    20.29 ( 0.73 )
    20.49 ( 0.73 )
        Week 12 [N=371, 362, 366, 374, 738, 734]
    14.4 ( 1.05 )
    18.04 ( 1.06 )
    19.16 ( 1.06 )
    18.35 ( 1.05 )
    22.97 ( 0.74 )
    22.76 ( 0.75 )
        EoT [N=400, 392, 398, 399, 800, 795]
    14.17 ( 1.01 )
    17.51 ( 1.02 )
    19.11 ( 1.02 )
    17.97 ( 1.01 )
    22.39 ( 0.72 )
    22.39 ( 0.72 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 6.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 6.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    4.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.42
         upper limit
    		 7.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.25
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    3.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 5.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Social

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in HRQL Subscale Score: Social
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    7.07 ( 0.78 )
    9.04 ( 0.79 )
    10.19 ( 0.78 )
    9.89 ( 0.78 )
    11.55 ( 0.55 )
    11.25 ( 0.55 )
        Week 8 [N=381, 370, 380, 385, 757, 761]
    10.65 ( 0.82 )
    11.5 ( 0.83 )
    12.34 ( 0.82 )
    12.02 ( 0.81 )
    14.89 ( 0.58 )
    14.73 ( 0.58 )
        Week 12 [N=371, 362, 366, 374, 738, 734]
    10.84 ( 0.83 )
    13.43 ( 0.84 )
    15.35 ( 0.84 )
    13.74 ( 0.83 )
    16.16 ( 0.59 )
    16.08 ( 0.59 )
        EoT [N=400, 392, 398, 399, 800, 795]
    10.56 ( 0.81 )
    13.04 ( 0.81 )
    14.87 ( 0.81 )
    13.57 ( 0.81 )
    15.84 ( 0.57 )
    15.82 ( 0.57 )
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    2.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 4.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.99
    Statistical analysis title
    		 Difference vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 4.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.99
    Statistical analysis title
    		 Difference vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 4.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.99
    Statistical analysis title
    		 Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.337
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 2.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.99

    Secondary: Patient’s Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT

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    End point title
    		 Patient’s Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
    End point description
    The PGIC is a 2-part questionnaire, assessing both the change in the patient’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). The analysis population was the FAS. The number of participants analyzed includes participants with data available. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 12: Very much improved
    8.4
    13.9
    15.1
    13.5
    19.8
    27.1
        Week 12: Much improved
    29.7
    32.9
    34.8
    40.5
    39.8
    34
        Week 12: Minimally improved
    29.7
    26.8
    26.5
    25.8
    22.2
    20.7
        Week 12: No change
    17.5
    12.9
    9.7
    8.9
    7.7
    7.3
        Week 12: Minimally worse
    4.1
    1.5
    2.2
    1.7
    0.8
    0.8
        Week 12: Much worse
    1
    1
    1.2
    0.5
    0.2
    0
        Week 12: Very much worse
    0.5
    0.5
    0.7
    0.5
    0.2
    0.5
        EoT: Very much improved
    8.4
    13.9
    15.1
    13.5
    20
    27.1
        EoT: Much improved
    30.4
    33.2
    34.8
    41
    40
    34.6
        EoT: Minimally improved
    29.9
    26.8
    27
    26.3
    22.6
    21.3
        EoT: No change
    18.2
    13.4
    10.2
    9.6
    7.9
    7.4
        EoT: Minimally worse
    4.1
    1.5
    2.2
    1.7
    0.8
    0.8
        EoT: Much worse
    1
    1
    1.2
    0.7
    0.4
    0
        EoT: Very much worse
    0.5
    0.5
    0.7
    0.5
    0.2
    0.6
    No statistical analyses for this end point

    Secondary: PGIC Scale: Impression in General Health at Week 12 and EoT

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    End point title
    		 PGIC Scale: Impression in General Health at Week 12 and EoT
    End point description
    The PGIC is a 2-part questionnaire, assessing both the change in the patient’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). The analysis population was the FAS. The number of participants analyzed includes participants with data available. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 12: Very much improved
    4.8
    8
    7.3
    7.7
    10.3
    14.6
        Week 12: Much improved
    23.9
    28
    29.2
    31.8
    33.4
    30.2
        Week 12: Minimally improved
    23.9
    21.5
    22.4
    24.1
    20.1
    20.9
        Week 12: No change
    31.8
    27.8
    27.5
    25.3
    23.9
    21.6
        Week 12: Minimally worse
    4.3
    2.9
    2.2
    1.4
    2.5
    2.2
        Week 12: Much worse
    1.7
    0.7
    1.2
    0.5
    0.5
    0.1
        Week 12: Very much worse
    0.2
    0.5
    0.5
    0.5
    0.2
    0.6
        EoT: Very much improved
    4.8
    8
    7.3
    7.7
    10.3
    14.6
        EoT: Much improved
    24.2
    28
    29.2
    31.8
    33.6
    30.4
        EoT: Minimally improved
    24.4
    21.5
    22.9
    24.1
    20.2
    21.3
        EoT: No change
    32.3
    28.3
    27.7
    26.5
    24.3
    21.9
        EoT: Minimally worse
    4.3
    2.9
    2.4
    1.9
    2.8
    2.7
        EoT: Much worse
    1.9
    0.7
    1.2
    0.5
    0.5
    0.2
        EoT: Very much worse
    0.5
    0.7
    0.5
    0.7
    0.2
    0.7
    No statistical analyses for this end point

    Secondary: Change from Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

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    End point title
    		 Change from Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: participants
    number (not applicable)
        No problems -> no problems
    204
    239
    225
    227
    449
    452
        No problems -> slight problems
    16
    20
    25
    22
    41
    38
        No problems -> moderate problems
    11
    12
    9
    8
    20
    10
        No problems -> severe problems
    1
    3
    3
    1
    1
    2
        No problems -> unable to walk about
    0
    1
    0
    0
    0
    1
        No problems -> no data
    2
    4
    5
    4
    6
    9
        Slight problems -> no problems
    33
    35
    35
    30
    76
    60
        Slight problems -> slight problems
    27
    20
    24
    19
    40
    49
        Slight problems -> moderate problems
    11
    6
    4
    6
    19
    9
        Slight problems -> severe problems
    5
    0
    3
    1
    2
    2
        Slight problems -> unable to walk about
    0
    0
    0
    0
    0
    0
        Slight problems -> no data
    2
    3
    0
    0
    0
    2
        Moderate problems -> no problems
    17
    7
    25
    18
    31
    46
        Moderate problems -> slight problems
    18
    10
    10
    22
    24
    25
        Moderate problems -> moderate problems
    21
    12
    10
    13
    33
    35
        Moderate problems -> severe problems
    10
    5
    4
    2
    8
    10
        Moderate problems -> unable to walk about
    0
    0
    0
    1
    1
    1
        Moderate problems -> no data
    1
    1
    0
    1
    0
    2
        Severe problems -> no problems
    3
    5
    9
    7
    12
    17
        Severe problems -> slight problems
    6
    7
    3
    4
    13
    8
        Severe problems -> moderate problems
    5
    4
    8
    8
    15
    15
        Severe problems -> severe problems
    8
    5
    1
    8
    11
    13
        Severe problems -> unable to walk about
    0
    0
    0
    0
    0
    0
        Severe problems -> no data
    0
    0
    2
    1
    1
    0
        Unable to walk about -> no problems
    0
    0
    0
    2
    2
    0
        Unable to walk about -> slight problems
    1
    0
    0
    0
    0
    0
        Unable to walk about -> moderate problems
    1
    0
    0
    0
    0
    1
        Unable to walk about -> severe problems
    1
    0
    0
    0
    0
    0
        Unable to walk about -> unable to walk about
    0
    0
    0
    0
    0
    0
        Unable to walk about -> no data
    0
    0
    0
    0
    0
    0
        No data -> no problems
    12
    7
    3
    6
    15
    16
        No data -> slight problems
    1
    0
    1
    2
    4
    2
        No data -> moderate problems
    0
    3
    1
    0
    0
    2
        No data -> severe problems
    0
    1
    0
    2
    2
    0
        No data -> unable to walk about
    0
    0
    0
    0
    0
    0
        No data -> no data
    1
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care

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    End point title
    		 Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: participants
    number (not applicable)
        No problems -> no problems
    311
    324
    336
    319
    652
    647
        No problems -> slight problems
    21
    17
    9
    20
    22
    26
        No problems -> moderate problems
    9
    5
    6
    3
    12
    4
        No problems -> severe problems
    0
    0
    1
    1
    1
    1
        No problems -> unable to wash/dress myself
    1
    0
    1
    0
    0
    0
        No problems -> no data
    4
    8
    6
    5
    6
    12
        Slight problems -> no problems
    17
    13
    16
    25
    35
    33
        Slight problems -> slight problems
    10
    10
    12
    12
    22
    26
        Slight problems -> moderate problems
    2
    4
    1
    2
    3
    7
        Slight problems -> severe problems
    2
    0
    0
    0
    1
    2
        Slight problems -> unable to wash/dress myself
    0
    0
    0
    0
    0
    0
        Slight problems -> no data
    1
    0
    0
    1
    1
    0
        Moderate problems -> no problems
    6
    8
    3
    2
    17
    16
        Moderate problems -> slight problems
    3
    1
    8
    3
    9
    7
        Moderate problems -> moderate problems
    9
    1
    2
    6
    8
    9
        Moderate problems -> severe problems
    0
    0
    0
    0
    2
    1
        Moderate problems -> unable to wash/dress myself
    0
    0
    0
    0
    0
    0
        Moderate problems -> no data
    0
    0
    0
    0
    0
    1
        Severe problems -> no problems
    2
    2
    2
    1
    3
    4
        Severe problems -> slight problems
    1
    0
    0
    3
    3
    3
        Severe problems -> moderate problems
    1
    2
    0
    0
    7
    3
        Severe problems -> severe problems
    3
    3
    0
    1
    1
    0
        Severe problems -> unable to wash/dress myself
    0
    0
    0
    0
    0
    0
        Severe problems -> no data
    0
    0
    1
    0
    0
    0
        Unable to wash/dress myself -> no problems
    0
    1
    1
    0
    0
    3
        Unable to wash/dress myself -> slight problems
    0
    0
    0
    0
    0
    0
        Unable to wash/dress myself -> moderate problems
    1
    0
    0
    0
    0
    0
        Unable to wash/dress myself -> severe problems
    0
    0
    0
    0
    0
    0
        Unable to wash/dress myself -> unable to wash/dres
    0
    0
    0
    1
    0
    0
        Unable to wash/dress myself -> no data
    0
    0
    0
    0
    0
    0
        No data -> no problems
    13
    8
    3
    8
    20
    18
        No data -> slight problems
    0
    2
    2
    1
    1
    0
        No data -> moderate problems
    0
    1
    0
    1
    0
    2
        No data -> severe problems
    0
    0
    0
    0
    0
    0
        No data -> unable to wash/dress myself
    0
    0
    0
    0
    0
    0
        No data -> no data
    1
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

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    End point title
    		 Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: participants
    number (not applicable)
        No problems -> No problems
    196
    228
    219
    223
    434
    451
        No problems -> Slight problems
    37
    25
    28
    25
    37
    48
        No problems -> Moderate problems
    9
    5
    9
    8
    13
    11
        No problems -> Severe problems
    2
    0
    1
    0
    1
    1
        No problems -> unable to do usual activities
    0
    0
    0
    0
    1
    1
        No problems -> no data
    2
    5
    4
    3
    5
    8
        Slight problems -> no problems
    45
    41
    52
    52
    98
    95
        Slight problems -> slight problems
    28
    29
    23
    25
    64
    56
        Slight problems -> moderate problems
    15
    9
    3
    8
    18
    12
        Slight problems -> severe problems
    2
    0
    2
    0
    2
    3
        Slight problems ->unable to do usual activities
    0
    0
    0
    0
    0
    0
        Slight problems -> no data
    2
    2
    0
    3
    2
    4
        Moderate problems -> no problems
    14
    13
    15
    13
    44
    26
        Moderate problems -> slight problems
    12
    9
    16
    14
    29
    30
        Moderate problems -> moderate problems
    15
    11
    9
    12
    25
    17
        Moderate problems -> severe problems
    1
    3
    0
    1
    3
    3
        Moderate problems ->unable to do usual activities
    0
    0
    0
    0
    0
    1
        Moderate problems -> no data
    1
    1
    2
    0
    0
    1
        Severe problems -> no problems
    7
    3
    7
    6
    7
    11
        Severe problems -> slight problems
    3
    4
    6
    2
    8
    8
        Severe problems -> moderate problems
    6
    7
    5
    6
    9
    7
        Severe problems -> severe problems
    4
    1
    1
    3
    2
    9
        Severe problems -> unable to do usual activities
    0
    1
    0
    0
    0
    0
        Severe problems -> no data
    0
    0
    1
    0
    0
    0
        No data -> no problems
    12
    7
    2
    7
    18
    15
        No data -> slight problems
    1
    2
    3
    1
    1
    3
        No data -> moderate problems
    0
    2
    0
    2
    2
    2
        No data -> severe problems
    0
    0
    0
    0
    0
    0
        No data -> unable to do usual activities
    0
    0
    0
    0
    0
    0
        No data -> no data
    1
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

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    End point title
    		 Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: participants
    number (not applicable)
        No pain/discomfort -> no pain/discomfort
    131
    175
    153
    154
    290
    317
        No pain/discomfort -> slight pain/discomfort
    38
    29
    37
    33
    74
    51
        No pain/discomfort -> moderate pain/discomfort
    10
    9
    17
    13
    19
    20
        No pain/discomfort -> severe pain/discomfort
    0
    0
    3
    3
    3
    1
        No pain/discomfort -> extreme pain/discomfort
    0
    0
    0
    0
    1
    0
        No pain/discomfort -> no data
    2
    3
    4
    2
    3
    8
        Slight pain/discomfort -> no pain/discomfort
    53
    51
    44
    46
    117
    105
        Slight pain/discomfort -> slight pain/discomfort
    54
    49
    45
    47
    94
    101
        Slight pain/discomfort -> moderate pain/discomfort
    12
    11
    14
    18
    15
    19
        Slight pain/discomfort -> severe pain/discomfort
    3
    0
    2
    0
    6
    3
        Slight pain/discomfort -> exteme pain/discomfort
    2
    0
    1
    0
    0
    0
        Slight pain/discomfort -> no data
    2
    5
    2
    2
    2
    4
        Moderate pain/discomfort -> no pain/discomfort
    20
    14
    24
    23
    45
    46
        Moderate pain/discomfort -> slight pain/discomfort
    23
    15
    20
    22
    46
    45
        Moderate pain/discomfort -> moderate pain/discomf
    31
    13
    16
    15
    34
    40
        Moderate pain/discomfort -> severe pain/discomfort
    4
    5
    3
    1
    4
    6
        Moderate pain/discomfort -> extreme pain/discomf
    0
    0
    0
    0
    1
    0
        Moderate pain/discomfort -> no data
    1
    0
    0
    1
    1
    1
        Severe pain/discomfort -> no pain/discomfort
    2
    4
    3
    1
    8
    12
        Severe pain/discomfort -> slight pain/discomfort
    3
    4
    6
    4
    11
    7
        Severe pain/discomfort -> moderate pain/discomfort
    8
    4
    6
    11
    15
    11
        Severe pain/discomfort -> severe pain/discomfort
    4
    3
    1
    4
    7
    8
        Severe pain/discomfort -> extreme pain/discomfort
    0
    1
    1
    0
    1
    0
        Severe pain/discomfort -> no data
    0
    0
    1
    0
    1
    0
        Extreme pain/discomfort -> no pain/discomfort
    0
    0
    0
    0
    1
    0
        Extreme pain/discomfort -> slight pain/discomfort
    1
    0
    0
    2
    1
    1
        Extreme pain/discomfort -> moderate pain/discomf
    0
    2
    1
    0
    1
    1
        Extreme pain/discomfort -> severe pain/discomfort
    0
    2
    1
    2
    3
    0
        Extreme pain/discomfort -> extreme pain/discomfort
    0
    0
    0
    0
    1
    0
        Extreme pain/discomfort -> no data
    0
    0
    0
    1
    0
    0
        No data -> no pain/discomfort
    11
    5
    3
    6
    14
    14
        No data -> slight pain/discomfort
    2
    2
    2
    2
    6
    3
        No data -> moderate pain/discomfort
    0
    4
    0
    2
    1
    3
        No data -> severe pain/discomfort
    0
    0
    0
    0
    0
    0
        No data -> extreme pain/discomfort
    0
    0
    0
    0
    0
    0
        No data -> no data
    1
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

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    End point title
    		 Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: participants
    number (not applicable)
        Not anxious -> not anxious
    137
    176
    187
    166
    360
    370
        Not anxious -> slightly anxious
    42
    27
    25
    29
    45
    50
        Not anxious -> moderately anxious
    7
    6
    6
    8
    13
    11
        Not anxious -> severely anxious
    0
    2
    5
    1
    2
    1
        Not anxious -> extremely anxious
    0
    0
    1
    0
    0
    1
        Not anxious -> no data
    2
    3
    2
    1
    3
    6
        Slightly anxious -> not anxious
    42
    60
    54
    59
    122
    134
        Slightly anxious -> slightly anxious
    49
    40
    45
    40
    79
    65
        Slightly anxious -> moderately anxious
    17
    16
    12
    17
    18
    16
        Slightly anxious -> severely anxious
    4
    2
    2
    2
    5
    5
        Slightly anxious -> extremely anxious
    0
    0
    0
    0
    1
    0
        Slightly anxious -> no data
    2
    3
    2
    5
    3
    4
        Moderately anxious -> not anxious
    12
    13
    12
    22
    42
    35
        Moderately anxious -> slightly anxious
    19
    17
    19
    14
    43
    41
        Moderately anxious -> moderately anxious
    17
    7
    11
    10
    18
    23
        Moderately anxious -> severely anxious
    2
    3
    0
    1
    8
    7
        Moderately anxious -> extremely anxious
    0
    1
    0
    0
    1
    1
        Moderately anxious -> no data
    1
    1
    2
    0
    1
    3
        Severely anxious -> not anxious
    7
    5
    6
    6
    12
    8
        Severely anxious -> slightly anxious
    3
    3
    4
    5
    11
    6
        Severely anxious -> moderately anxious
    5
    7
    2
    6
    6
    7
        Severely anxious -> severely anxious
    10
    1
    2
    5
    5
    2
        Severely anxious -> extremely anxious
    1
    0
    0
    1
    0
    3
        Severely anxious -> no data
    0
    1
    1
    0
    0
    0
        Extremely anxious -> not anxious
    2
    1
    0
    0
    2
    1
        Extremely anxious -> slightly anxious
    2
    2
    1
    2
    2
    3
        Extremely anxious -> moderately anxious
    1
    1
    1
    1
    2
    1
        Extremely anxious -> severely anxious
    0
    1
    1
    3
    0
    1
        Extremely anxious -> extremely anxious
    0
    0
    2
    1
    1
    2
        Extremely anxious -> no data
    0
    0
    0
    0
    0
    0
        No data -> not anxious
    9
    8
    3
    6
    13
    14
        No data -> slightly anxious
    4
    1
    2
    2
    6
    3
        No data -> moderately anxious
    0
    2
    0
    2
    1
    2
        No data -> severely anxious
    0
    0
    0
    0
    0
    1
        No data -> extremely anxious
    0
    0
    0
    0
    1
    0
        No data -> no data
    1
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Time Work Missed

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    End point title
    		 Change from Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Time Work Missed
    End point description
    The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with both baseline and post-baseline values are included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of work time missed
    arithmetic mean (standard deviation)
        Week 12 [N=128, 127, 139, 130, 274, 244]
    -2.98 ( 21.7 )
    -0.33 ( 22.03 )
    -1.72 ( 18.7 )
    -2.47 ( 14.13 )
    -2.06 ( 20.93 )
    -2.59 ( 19.65 )
        EoT [N=129, 127, 140, 132, 277, 247]
    -2.96 ( 21.61 )
    -0.33 ( 22.03 )
    -1.71 ( 18.64 )
    -2.44 ( 14.03 )
    -1.48 ( 21.95 )
    -2.55 ( 19.54 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

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    End point title
    		 Change from Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
    End point description
    The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with both baseline and post-baseline values are included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of impairment while working
    arithmetic mean (standard deviation)
        Week 12 [N=126,122, 138, 130, 271, 241]
    -11.27 ( 25.36 )
    -14.96 ( 26.21 )
    -12.25 ( 25.06 )
    -10.85 ( 25.58 )
    -14.69 ( 26.99 )
    -13.07 ( 27.35 )
        EoT [N=127, 122, 139, 132, 273, 244]
    -11.18 ( 25.28 )
    -14.96 ( 26.21 )
    -12.37 ( 25.01 )
    -10.98 ( 25.68 )
    -14.58 ( 26.92 )
    -12.87 ( 27.31 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 8 and 12 in the Patient's Assessment of TS-VAS

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    End point title
    		 Change from Baseline to Weeks 4, 8 and 12 in the Patient's Assessment of TS-VAS
    End point description
    The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: units on a scale
    least squares mean (standard error)
        Week 4 [N=395, 386, 391, 394, 788, 788]
    1.14 ( 0.12 )
    1.68 ( 0.12 )
    1.77 ( 0.12 )
    1.82 ( 0.12 )
    2.06 ( 0.08 )
    2.13 ( 0.08 )
        Week 8 [N=380, 369, 380, 385, 754, 756]
    1.5 ( 0.11 )
    2.16 ( 0.12 )
    2.09 ( 0.11 )
    2.2 ( 0.11 )
    2.48 ( 0.08 )
    2.48 ( 0.08 )
        Week 12 [N=370, 361, 366, 373, 736, 732]
    1.47 ( 0.12 )
    2.24 ( 0.12 )
    2.23 ( 0.12 )
    2.32 ( 0.12 )
    2.58 ( 0.08 )
    2.63 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    410
    827
    827
    Units: percentage of particpants
    number (not applicable)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    23.2
    24.9
    27.6
    28.9
    35.1
    37.3
        Week 8 [N=397, 385, 386, 386, 784, 769]
    28.7
    35.3
    40.7
    38.3
    45.3
    48.2
        Week 12 [N=374, 369, 369, 379, 754, 750]
    38
    42.5
    47.4
    42.7
    52.3
    52.7
        EoT [N=412, 409, 406, 413, 823, 816]
    37.6
    40.6
    46.3
    42.9
    50.7
    52.2
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.69
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.81
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.93
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.73

    Secondary: Percentage of Participants with ≥ 10 Points Improvement from Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with ≥ 10 Points Improvement from Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    56.4
    62.6
    69.9
    73.9
    73.9
    75.8
        Week 8 [N=381, 370, 380, 385, 757, 761]
    62.2
    71.6
    73.4
    79.2
    83.9
    82.8
        Week 12 [N=371, 362, 366, 374, 738, 734]
    66
    72.1
    78.4
    82.4
    83.5
    85.1
        EoT [N=400, 392, 398, 399, 800, 795]
    65.3
    71.2
    77.1
    81.2
    82.8
    84.3
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.224
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.69
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.96
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 2.67
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 2.26

    Secondary: Percentage of Participants with ≥ 10 Points Improvement from Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with ≥ 10 Points Improvement from Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=397, 388, 392, 394, 790, 789]
    45.3
    52.8
    59.7
    61.7
    62.9
    61.3
        Week 8 [N=381, 370, 380, 385, 757, 761]
    51.2
    62.2
    65.3
    66.2
    71.5
    69.3
        Week 12 [N=371, 362, 366, 374, 738, 734]
    57.7
    62.4
    69.1
    71.7
    76.3
    71.8
        EoT [N=400, 392, 398, 399, 800, 795]
    56.8
    61
    68.3
    71.2
    74.5
    71.1
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.077
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.72
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.321
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.53
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 2.53
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.294
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.53

    Secondary: Percentage of Participants with 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT). The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    41.1
    45.3
    56.7
    53.2
    57.2
    60.6
        Week 8 [N=397, 385, 386, 386, 784, 769]
    54.9
    61.8
    63.7
    65.3
    69.8
    70.6
        Week 12 [N=374, 369, 369, 379, 754, 750]
    58.6
    66.4
    70.2
    71
    75.9
    76.1
        EoT [N=412, 409, 406, 413, 823, 816]
    59.5
    64.5
    69
    70.5
    74.5
    75.7
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.251
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.53
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.107
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.64
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 2.07
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 1.85

    Secondary: Percentage of Participants with Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with micturition frequency normalization is defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Participants with less < 8 micturitions per 24 hours at baseline was not included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    24.1
    30.8
    25.4
    31.1
    36
    37.7
        Week 8 [N=397, 385, 386, 386, 784, 769]
    28.7
    37.9
    34.5
    37
    45.3
    49
        Week 12 [N=374, 369, 369, 379, 754, 750]
    29.7
    42.3
    40.7
    44.9
    50.8
    53.1
        EoT [N=412, 409, 406, 413, 823, 816]
    31.1
    42.1
    40.1
    45
    51.3
    52.6
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.67
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.84
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.9
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 2.08

    Secondary: Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=406, 406, 402, 402, 817, 810]
    12.8
    13.1
    16.7
    17.7
    23.9
    26
        Week 8 [N=397, 385, 386, 386, 784, 769]
    19.1
    24.4
    29.8
    28.2
    36.6
    38.4
        Week 12 [N=374, 369, 369, 379, 754, 750]
    29.1
    32.2
    35
    31.9
    42.4
    43.7
        EoT [N=412, 409, 406, 413, 823, 816]
    28.6
    30.6
    34
    31.5
    40.9
    43.1
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.92
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 2.11
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 2.07
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 2.04

    Secondary: Percentage of Participants with ≥ 1 Point Improvement from Baseline in PPBC at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with ≥ 1 Point Improvement from Baseline in PPBC at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=397, 388, 393, 394, 791, 791]
    48.9
    52.8
    60.3
    58.1
    63.1
    62.7
        Week 8 [N=381, 372, 380, 385, 758, 761]
    56.4
    65.3
    69.7
    72.7
    71.6
    75.4
        Week 12 [N=371, 362, 366, 375, 739, 735]
    59.8
    66.9
    73.8
    74.1
    76.6
    80
        EoT [N=400, 393, 398, 399, 801, 795]
    59.8
    65.4
    72.4
    71.9
    75.7
    78.4
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.78
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 2.27
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.32
         upper limit
    		 2.36
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 2.04

    Secondary: Percentage of Participants with Major (≥ 2 points) Improvement from Baseline in PPBC at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants with Major (≥ 2 points) Improvement from Baseline in PPBC at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=397, 388, 393, 394, 791, 791]
    15.9
    20.6
    22.4
    27.4
    31.1
    31.1
        Week 8 [N=381, 372, 380, 385, 758, 761]
    27
    33.3
    35
    40.5
    42.7
    46.4
        Week 12 [N=371, 362, 366, 375, 739, 735]
    29.6
    39
    42.3
    44.5
    50.7
    52.9
        EoT [N=400, 393, 398, 399, 801, 795]
    29.5
    37.2
    40.7
    42.6
    49.7
    51.2
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.87
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 2.17
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 2.3
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 2.19

    Secondary: Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=388, 385, 387, 385, 784, 778]
    28.6
    34.8
    45.7
    44.9
    47.8
    52.3
        Week 8 [N=374, 366, 375, 372, 750, 742]
    39.8
    50
    51.5
    56.5
    63.1
    63.5
        Week 12 [N=360, 350, 355, 363, 727, 721]
    45
    55.7
    59.4
    63.1
    66.7
    69.5
        EoT [N=396, 391, 395, 398, 798, 790]
    45.2
    54
    58.2
    62.6
    65.2
    68.2
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.381
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.45
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.7
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 2
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 2.03

    Secondary: Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=388, 385, 387, 385, 784, 778]
    23.2
    28.3
    39.8
    37.7
    40.4
    40.5
        Week 8 [N=374, 366, 375, 372, 750, 742]
    32.9
    43.2
    46.1
    48.4
    54.1
    53
        Week 12 [N=360, 350, 355, 363, 727, 721]
    39.2
    48.3
    53.5
    54.8
    61.6
    59.2
        EoT [N=396, 391, 395, 398, 798, 790]
    39.1
    46
    52.9
    54
    59
    58.2
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.59
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.62
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 2.13
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.63

    Secondary: Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=388, 384, 387, 385, 785, 780]
    23.2
    27.9
    37.7
    34.5
    39.9
    42.9
        Week 8 [N=374, 367, 375, 372, 751, 742]
    35.6
    44.7
    50.1
    51.3
    53.8
    57.7
        Week 12 [N=360, 350, 355, 364, 728, 722]
    40.6
    51.7
    54.9
    56.9
    62
    65.4
        EoT [N=396, 392, 395, 398, 799, 790]
    40.9
    48.5
    53.9
    56
    59.9
    63.8
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.52
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.89
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 2.06
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 2.05

    Secondary: Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours, at least 10 Points Improvement on OAB-q Symptom Bother Scale and at least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours, at least 10 Points Improvement on OAB-q Symptom Bother Scale and at least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=388, 384, 387, 385, 784, 778]
    17.8
    24
    33.6
    31.4
    37.5
    40.2
        Week 8 [N=374, 366, 375, 372, 750, 742]
    29.7
    41.3
    43.2
    47.8
    51.6
    54.7
        Week 12 [N=360, 350, 355, 363, 727, 721]
    35.8
    47.7
    49.6
    54.5
    58.2
    62
        EoT [N=396, 391, 395, 398, 798, 790]
    36.1
    45
    48.4
    53.3
    56.3
    60.3
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.335
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.46
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.81
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 2.02
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.33
         upper limit
    		 2.21

    Secondary: Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours, at least 10 Points Improvement on OAB-q HRQL Total Score and at least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

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    End point title
    		 Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes per 24 Hours, at least 10 Points Improvement on OAB-q HRQL Total Score and at least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
    End point description
    The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    418
    410
    411
    415
    827
    827
    Units: percentage of participants
    number (not applicable)
        Week 4 [N=388, 384, 387, 385, 784, 778]
    15.2
    20.6
    30
    28.6
    32.7
    33.4
        Week 8 [N=374, 366, 375, 372, 750, 742]
    24.9
    36.9
    38.9
    43
    46.3
    46.8
        Week 12 [N=360, 350, 355, 362, 727, 721]
    33.3
    42
    45.6
    49.9
    54.5
    54.2
        EoT [N=396, 391, 395, 398, 798, 790]
    33.3
    39.1
    44.8
    49.2
    51.6
    52.8
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (1) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.416
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.43
    Statistical analysis title
    		 Odds ratio vs. Solifenacin 5 mg (2) (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.105
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.59
    Statistical analysis title
    		 Odds ratio vs. Mirabegron 25 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
    Comparison groups
    Mirabegron 25 mg v Solifenacin 5 mg + mirabegron 25 mg
    Number of subjects included in analysis
    1237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 2.16
    Statistical analysis title
    		 Odds ratio vs. Mirabgeron 50 mg (EoT)
    Statistical analysis description
    Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.87

    Secondary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
    End point description
    A TEAE refers to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing. The analysis population was the Safety Analysis Set (SAF), which comprised all randomized participants who received ≥ 1 dose of double-blind treatment and excluded participants from site 10153.
    End point type
    Secondary
    End point timeframe
    From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    429
    423
    422
    423
    853
    848
    Units: participants
        Any TEAE
    145
    135
    147
    149
    345
    314
        Drug-related TEAEs
    45
    37
    52
    63
    157
    150
        Deaths
    0
    0
    0
    0
    0
    0
        Serious TEAEs
    8
    6
    5
    3
    12
    19
        Drug-related serious TEAEs
    0
    1
    1
    0
    2
    3
        TEAEs leading to discontinuation
    9
    7
    10
    7
    20
    22
        Drug-related TEAEs leading to discontinuation
    7
    4
    6
    5
    17
    19
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume

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    End point title
    		 Change from Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
    End point description
    PVR volume was assessed by ultrasonography or a bladder scanner. The analysis population was the SAF. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    429
    423
    422
    423
    853
    848
    Units: mL
    arithmetic mean (standard deviation)
        Week 4 [N=408, 397, 398, 412, 815, 812]
    -0.8 ( 29.9 )
    1.6 ( 28 )
    -2.1 ( 29.7 )
    5.8 ( 35.6 )
    7.2 ( 47.7 )
    10.6 ( 51.1 )
        Week 8 [N=393, 378, 383, 393, 779, 784]
    -1.9 ( 28.6 )
    -0.4 ( 29.8 )
    -0.6 ( 34.4 )
    5.4 ( 35.2 )
    7 ( 37.4 )
    9.9 ( 46 )
        Week 12 [N=382, 376, 370, 383, 766, 763]
    -1 ( 29.9 )
    1 ( 29.8 )
    0 ( 30.1 )
    4.7 ( 33.1 )
    7.9 ( 44.4 )
    9.6 ( 50.1 )
        EoT [N=410, 401, 404, 414, 821, 815]
    -1 ( 29.4 )
    0.7 ( 29.1 )
    -0.8 ( 30 )
    4.8 ( 33.3 )
    9 ( 55 )
    1.5 ( 32.5 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Mean 24 hours (h), Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Mean 24 hours (h), Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The analysis population was the ABPM analysis set (ABPMAS) which consisted of all participants in the SAF for whom at least 1 ABPM variable (mean value at tmax (4-6h), mean 24-h value, maximum 1-h change from time-matched baseline value, mean daytime value, mean nighttime value or peak/trough difference) could be calculated at baseline and postbaseline visit. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 24-hour mean [N=76, 66, 67, 72, 141, 157]
    -1 ( 1.22 )
    -2.04 ( 1.31 )
    0.96 ( 1.3 )
    1.03 ( 1.26 )
    -0.85 ( 0.9 )
    0.31 ( 0.85 )
        Week 4 mean daytime [N=72, 60, 62, 60, 129, 147]
    -1.55 ( 1.22 )
    -1.19 ( 1.33 )
    -0.67 ( 1.31 )
    -1.13 ( 1.34 )
    -1.63 ( 0.91 )
    -0.53 ( 0.85 )
        Week 4 mean nighttime [N=82, 74, 75, 72, 147, 161]
    -0.51 ( 1.38 )
    -1.14 ( 1.46 )
    1.42 ( 1.44 )
    0.41 ( 1.47 )
    1.14 ( 1.03 )
    0.54 ( 0.98 )
        Week 12 24-hour mean [N=67, 62, 63, 60, 121, 139]
    -1.97 ( 1.37 )
    -2.7 ( 1.42 )
    -1.75 ( 1.41 )
    0.4 ( 1.45 )
    -0.71 ( 1.02 )
    0.4 ( 0.95 )
        Week 12 mean daytime [N=65, 56, 55, 53, 106, 116]
    -2.22 ( 1.37 )
    -2.53 ( 1.46 )
    -2.14 ( 1.48 )
    -2.09 ( 1.5 )
    -0.39 ( 1.06 )
    -0.71 ( 1.02 )
        Week 12 mean nighttime [N=75, 64, 71, 65, 132,146]
    -1.03 ( 1.64 )
    -2.81 ( 1.77 )
    -0.77 ( 1.68 )
    1.31 ( 1.76 )
    0.11 ( 1.23 )
    0.79 ( 1.17 )
        EoT 24-hour mean [N=80, 73, 76, 78, 150, 168]
    -1.73 ( 1.24 )
    -3.44 ( 1.29 )
    -1.14 ( 1.27 )
    0.37 ( 1.25 )
    -0.52 ( 0.9 )
    -0.08 ( 0.85 )
        EoT mean daytime [N=78, 67, 69, 69, 137, 153]
    -2.01 ( 1.22 )
    -3.29 ( 1.31 )
    -1.92 ( 1.3 )
    -2.17 ( 1.3 )
    -0.68 ( 0.92 )
    -1.28 ( 0.87 )
        EoT mean nighttime [N=88, 80, 82, 82, 160, 175]
    -1 ( 1.47 )
    -3.48 ( 1.54 )
    -0.6 ( 1.52 )
    1.42 ( 1.52 )
    0.41 ( 1.09 )
    0.91 ( 1.04 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 24-hour mean [N=76, 66, 67, 72, 141, 157]
    -0.7 ( 0.5 )
    -0.86 ( 0.54 )
    0.22 ( 0.54 )
    0.25 ( 0.52 )
    0.03 ( 0.37 )
    0.38 ( 0.35 )
        Week 4 mean daytime [N=72, 60, 62, 60, 129, 147]
    -1.25 ( 0.53 )
    -0.36 ( 0.58 )
    -0.33 ( 0.57 )
    -0.77 ( 0.58 )
    -0.4 ( 0.4 )
    0.07 ( 0.37 )
        Week 4 mean nighttime [N=82, 74, 75, 72, 147, 161]
    -0.12 ( 0.59 )
    -0.97 ( 0.62 )
    0.4 ( 0.62 )
    0.48 ( 0.63 )
    0.93 ( 0.44 )
    0.47 ( 0.42 )
        Week 12 24-hour mean [N=67, 62, 63, 60, 121, 139]
    -0.8 ( 0.56 )
    -0.93 ( 0.58 )
    -0.19 ( 0.57 )
    0.43 ( 0.59 )
    -0.37 ( 0.41 )
    0.31 ( 0.39 )
        Week 12 mean daytime [N=65, 56, 55, 53, 106, 116]
    -0.85 ( 0.6 )
    -0.54 ( 0.64 )
    -0.4 ( 0.65 )
    -0.33 ( 0.66 )
    -0.06 ( 0.46 )
    -0.18 ( 0.44 )
        Week 12 mean nighttime [N=75, 64, 71, 65, 132,146]
    -0.49 ( 0.66 )
    -1.39 ( 0.71 )
    -0.03 ( 0.68 )
    0.92 ( 0.71 )
    0.23 ( 0.49 )
    0.49 ( 0.47 )
        EoT 24-hour mean [N=80, 73, 76, 78, 150, 168]
    -0.96 ( 0.51 )
    -1.41 ( 0.53 )
    -0.11 ( 0.52 )
    0.05 ( 0.52 )
    -0.02 ( 0.37 )
    0.25 ( 0.35 )
        EoT mean daytime [N=78, 67, 69, 69, 137, 153]
    -1.17 ( 0.53 )
    -0.98 ( 0.58 )
    -0.69 ( 0.57 )
    -0.79 ( 0.57 )
    -0.18 ( 0.4 )
    -0.36 ( 0.38 )
        EoT mean nighttime [N=88, 80, 82, 82, 160, 178]
    -0.41 ( 0.6 )
    -2 ( 0.63 )
    0.08 ( 0.63 )
    0.71 ( 0.63 )
    0.56 ( 0.45 )
    0.61 ( 0.43 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: beats per minute (bpm)
    least squares mean (standard error)
        Week 4 24-hour mean [N=76, 66, 67, 72, 141, 157]
    -0.83 ( 0.63 )
    1.14 ( 0.68 )
    2.32 ( 0.67 )
    0.36 ( 0.65 )
    0.4 ( 0.46 )
    0.69 ( 0.44 )
        Week 4 mean daytime [N=72, 60, 62, 60, 129, 147]
    -0.7 ( 0.73 )
    1.19 ( 0.79 )
    3.52 ( 0.78 )
    0.37 ( 0.8 )
    -0.05 ( 0.54 )
    0.61 ( 0.51 )
        Week 4 mean nighttime [N=82, 74, 75, 72, 147, 161]
    -0.72 ( 0.68 )
    0.98 ( 0.71 )
    1.77 ( 0.7 )
    1.09 ( 0.72 )
    0.86 ( 0.5 )
    0.86 ( 0.48 )
        Week 12 24-hour mean [N=67, 62, 63, 60, 121, 189]
    0.7 ( 0.72 )
    0.38 ( 0.74 )
    1.19 ( 0.74 )
    0.12 ( 0.76 )
    0.94 ( 0.53 )
    1.44 ( 0.5 )
        Week 12 mean daytime [N=65, 56, 55, 53, 106, 116]
    0.89 ( 0.82 )
    0.25 ( 0.88 )
    2.12 ( 0.89 )
    -0.13 ( 0.9 )
    0.84 ( 0.64 )
    1.36 ( 0.61 )
        Week 12 mean nighttime [N=75, 64, 71, 65, 132,146]
    0.34 ( 0.71 )
    0.21 ( 0.77 )
    0.19 ( 0.73 )
    0.06 ( 0.76 )
    0.76 ( 0.53 )
    1.52 ( 0.51 )
        EoT 24-hour mean [N=80, 73, 76, 78, 150, 168]
    0.41 ( 0.65 )
    0.63 ( 0.68 )
    1.67 ( 0.67 )
    0.02 ( 0.66 )
    0.85 ( 0.47 )
    1.52 ( 0.45 )
        EoT mean daytime [N=78, 67, 69, 69, 137, 153]
    0.45 ( 0.74 )
    0.37 ( 0.8 )
    2.64 ( 0.79 )
    -0.07 ( 0.79 )
    0.32 ( 0.56 )
    1.24 ( 0.53 )
        EoT mean nighttime [N=88, 80, 82, 82, 160, 175]
    0.39 ( 0.66 )
    0.82 ( 0.69 )
    0.75 ( 0.68 )
    0.45 ( 0.68 )
    1.21 ( 0.49 )
    1.64 ( 0.47 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Mean SBP 4 to 6 Hours Postdose

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Mean SBP 4 to 6 Hours Postdose
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 [N=77, 63, 73, 72, 142, 160]
    -2.71 ( 1.68 )
    0.34 ( 1.86 )
    -1.03 ( 1.72 )
    -1.77 ( 1.74 )
    -1.55 ( 1.23 )
    -1.47 ( 1.17 )
        Week 12 [N=72, 60, 64, 59, 130, 131]
    -4.86 ( 1.78 )
    -2.13 ( 1.95 )
    -1.64 ( 1.88 )
    -3.15 ( 1.96 )
    -0.26 ( 1.32 )
    0.6 ( 1.32 )
        EoT [N=83, 75, 79, 78, 157, 169]
    -4.4 ( 1.6 )
    -2.19 ( 1.68 )
    -1.94 ( 1.64 )
    -3.64 ( 1.65 )
    -0.61 ( 1.16 )
    -0.98 ( 1.12 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Mean DBP 4 to 6 Hours Postdose

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Mean DBP 4 to 6 Hours Postdose
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EOT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 [N=77, 63, 73, 72, 142, 160]
    -1.24 ( 0.84 )
    0.09 ( 0.93 )
    -0.65 ( 0.86 )
    -0.48 ( 0.87 )
    -0.22 ( 0.62 )
    -0.71 ( 0.58 )
        Week 12 [N=72, 60, 64, 59, 130, 131]
    -1.74 ( 0.92 )
    -0.45 ( 1 )
    -0.31 ( 0.97 )
    -1.49 ( 1.01 )
    0.48 ( 0.68 )
    -0.03 ( 0.68 )
        EoT [N=83, 75, 79, 78, 157, 169]
    -1.85 ( 0.84 )
    -0.71 ( 0.88 )
    -0.71 ( 0.85 )
    -1.22 ( 0.86 )
    0.44 ( 0.61 )
    -0.8 ( 0.59 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Mean Pulse Rate 4 to 6 Hours Postdose

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Mean Pulse Rate 4 to 6 Hours Postdose
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: bpm
    least squares mean (standard error)
        Week 4 [N=77, 63, 73, 72, 142, 160]
    0.02 ( 1.08 )
    2.39 ( 1.19 )
    3.68 ( 1.1 )
    0.47 ( 1.11 )
    -0.91 ( 0.79 )
    0.67 ( 0.75 )
        Week 12 [N=72, 60, 64, 59, 130, 131]
    0.1 ( 1.1 )
    1.22 ( 1.2 )
    1.87 ( 1.16 )
    0.37 ( 1.21 )
    0.15 ( 0.81 )
    1.39 ( 0.81 )
        EoT [N=83, 75, 79, 78, 157, 169]
    -0.43 ( 1.05 )
    0.82 ( 1.1 )
    3.41 ( 1.07 )
    -1.25 ( 1.08 )
    0.34 ( 0.76 )
    1.25 ( 0.73 )
    No statistical analyses for this end point

    Secondary: Maximum 1-hour Change from Time-matched Baseline in SBP at Weeks 4, 12 and EoT

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    End point title
    		 Maximum 1-hour Change from Time-matched Baseline in SBP at Weeks 4, 12 and EoT
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 [N=76, 66, 67, 72, 141, 157]
    34.05 ( 2.06 )
    31.14 ( 2.2 )
    38.2 ( 2.19 )
    35.16 ( 2.11 )
    32.88 ( 1.51 )
    32.8 ( 1.43 )
        Week 12 [N=67, 62, 63, 60, 121, 139]
    33.21 ( 2.3 )
    30.68 ( 2.38 )
    32.88 ( 2.36 )
    35.11 ( 2.42 )
    33.53 ( 1.7 )
    32.82 ( 1.59 )
        EoT [N=80, 73, 76, 78, 150, 168]
    34.98 ( 2.11 )
    30.65 ( 2.2 )
    33.53 ( 2.16 )
    34.95 ( 2.14 )
    34.7 ( 1.54 )
    32.55 ( 1.45 )
    No statistical analyses for this end point

    Secondary: Maximum 1-hour Change from Time-matched Baseline in DBP at Weeks 4, 12 and EoT

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    End point title
    		 Maximum 1-hour Change from Time-matched Baseline in DBP at Weeks 4, 12 and EoT
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 [N=76, 66, 67, 72, 141, 157]
    18.78 ( 1.27 )
    19.15 ( 1.36 )
    20.41 ( 1.35 )
    20.02 ( 1.31 )
    20.74 ( 0.93 )
    20.27 ( 0.88 )
        Week 12 [N=67, 62, 63, 60, 121, 139]
    19.68 ( 1.23 )
    19.52 ( 1.28 )
    20.41 ( 1.27 )
    21.18 ( 1.3 )
    19.26 ( 0.92 )
    20.01 ( 0.85 )
        EoT [N=80, 73, 76, 78, 150, 168]
    20.29 ( 1.16 )
    19.29 ( 1.22 )
    20.71 ( 1.19 )
    20.47 ( 1.18 )
    20.29 ( 0.85 )
    20.36 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Maximum 1-hour Change from Time-matched Baseline in Pulse Rate at Weeks 4, 12 and EoT

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    End point title
    		 Maximum 1-hour Change from Time-matched Baseline in Pulse Rate at Weeks 4, 12 and EoT
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 bpm) were included in the analysis. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4,12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: bpm
    least squares mean (standard error)
        Week 4 [N=76, 66, 67, 72, 141, 157]
    22.34 ( 1.35 )
    23.86 ( 1.44 )
    25.12 ( 1.43 )
    24.28 ( 1.38 )
    21.48 ( 0.99 )
    21.8 ( 0.94 )
        Week 12 [N=67, 62, 63, 60, 121, 139]
    22.63 ( 1.42 )
    23.54 ( 1.47 )
    26.03 ( 1.46 )
    23.52 ( 1.5 )
    22.6 ( 1.05 )
    24.08 ( 0.98 )
        EoT [N=80, 73, 76, 78, 150, 168]
    23.01 ( 1.31 )
    24.12 ( 1.37 )
    26.23 ( 1.34 )
    23.33 ( 1.33 )
    22.66 ( 0.96 )
    24.14 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference is defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: mmHg
    least squares mean (standard error)
        Week 4 [N=76, 66, 67, 72, 141, 157]
    -0.71 ( 1.86 )
    0.14 ( 1.99 )
    -0.69 ( 1.98 )
    0.85 ( 1.91 )
    -1.61 ( 1.36 )
    0.41 ( 1.29 )
        Week 12 [N=67, 62, 63, 60, 121, 139]
    1.18 ( 1.98 )
    -2.45 ( 2.05 )
    -4.55 ( 2.03 )
    -1.63 ( 2.08 )
    0.68 ( 1.47 )
    0.62 ( 1.37 )
        EoT [N=80, 73, 76, 78, 150, 168]
    1.15 ( 1.83 )
    -1.38 ( 1.91 )
    -2.3 ( 1.87 )
    -0.97 ( 1.85 )
    0.25 ( 1.33 )
    0.68 ( 1.26 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference is defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    176
    189
    Units: nnHg
    least squares mean (standard error)
        Week 4 [N=76, 66, 67, 72, 141, 157]
    -0.76 ( 1.31 )
    -1.08 ( 1.4 )
    -0.2 ( 1.39 )
    -1.6 ( 1.34 )
    0.39 ( 0.96 )
    -0.56 ( 0.91 )
        Week 12 [N=67, 62, 63, 60, 121, 139]
    0.53 ( 1.3 )
    0.15 ( 1.34 )
    -1.9 ( 1.33 )
    -0.66 ( 1.36 )
    -1.24 ( 0.96 )
    0.46 ( 0.9 )
        EoT [N=80, 73, 76, 78, 150, 168]
    0.87 ( 1.23 )
    0.27 ( 1.28 )
    -0.96 ( 1.26 )
    -1.67 ( 1.24 )
    -0.98 ( 0.89 )
    0.52 ( 0.85 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 4, 12 and EoT in Pulse Rate Peak/Trough Difference

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    End point title
    		 Change from Baseline to Weeks 4, 12 and EoT in Pulse Rate Peak/Trough Difference
    End point description
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference is defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. The analysis population was the ABPMAS. N is the number of participants analyzed with data available at each time point. LOCF for EoT was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12
    End point values
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    92
    85
    87
    86
    141
    157
    Units: bpm
    least squares mean (standard error)
        Week 4 [N=76, 66, 67, 72, 141, 157]
    1.16 ( 1.38 )
    0.46 ( 1.48 )
    1.54 ( 1.46 )
    0.78 ( 1.41 )
    -0.68 ( 1.01 )
    -0.51 ( 0.96 )
        Week 12 [N=67, 62, 63, 60, 121, 139]
    3.35 ( 1.45 )
    -0.04 ( 1.5 )
    1.15 ( 1.49 )
    3.49 ( 1.53 )
    -0.53 ( 1.07 )
    1.48 ( 1 )
        EoT [N=80, 73, 76, 78, 150, 168]
    2.48 ( 1.32 )
    0.45 ( 1.37 )
    1.14 ( 1.35 )
    3.16 ( 1.33 )
    -0.02 ( 0.96 )
    1.8 ( 0.91 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received matching placebo once a day for 12 weeks.

    Reporting group title
    Mirabegron 25 mg
    Reporting group description
    		 Participants who received mirabegron 25 mg once a day for 12 weeks.

    Reporting group title
    Mirabegron 50 mg
    Reporting group description
    		 Participants who received mirabegron 50 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 25 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 50 mg
    Reporting group description
    		 Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

    Serious adverse events
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 429 (1.86%)
    6 / 423 (1.42%)
    5 / 422 (1.18%)
    3 / 423 (0.71%)
    12 / 853 (1.41%)
    19 / 848 (2.24%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    1 / 423 (0.24%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    1 / 422 (0.24%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    2 / 848 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    1 / 422 (0.24%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Renal stone removal
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    1 / 422 (0.24%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    1 / 423 (0.24%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    1 / 423 (0.24%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    1 / 422 (0.24%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    1 / 422 (0.24%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrub typhus
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    1 / 423 (0.24%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 423 (0.24%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    0 / 853 (0.00%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 423 (0.00%)
    0 / 422 (0.00%)
    0 / 423 (0.00%)
    1 / 853 (0.12%)
    0 / 848 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Mirabegron 25 mg Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 25 mg Solifenacin 5 mg + mirabegron 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 429 (1.86%)
    17 / 423 (4.02%)
    14 / 422 (3.32%)
    25 / 423 (5.91%)
    72 / 853 (8.44%)
    60 / 848 (7.08%)
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    8 / 429 (1.86%)
    17 / 423 (4.02%)
    14 / 422 (3.32%)
    25 / 423 (5.91%)
    72 / 853 (8.44%)
    60 / 848 (7.08%)
         occurrences all number
    8
    18
    14
    27
    73
    61

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2013
    Substantial amendment 1, dated 09 Sep 2013, is summarized as follows: ● Inclusion criterion 3 relating to female patients of childbearing potential and inclusion criterion 14 relating to the number of urgency episodes/24 h, respectively, were clarified. ● The sample size justification for change from baseline in mean number of incontinence episodes/24 h was modified to accommodate the 7-day diary period. ● The efficacy analyses were modified. The adjustment for multiplicity was changed from a hierarchical testing procedure to a sequential Bonferroni-based testing procedure to control the type 1 error across the variables. Additional sensitivity analyses for the coprimary and key secondary efficacy endpoints were added. ● Expected adverse drug reactions (ADRs) and expected risks were updated in line with the company core data sheets. ● Antidepressant drugs with anticholinergic ADRs were moved from the list of restricted medications to prohibited medications as these drugs sometimes are used to treat OAB. ● Nonsubstantial changes were implemented in addition to the substantial changes mentioned above.
    12 Nov 2014
    Substantial amendment 2, dated 12 Nov 2014, is summarized as follows. ● The number of screened patients was increased to meet the target of 3392 randomized patients. ● The number of patients to be randomized in the ABPM substudy was increased to ensure the number of 608 evaluable patients. In addition, the investigator was allowed to repeat the baseline (directly) and week 4 (at week 8) ABPM assessments to increase the number of evaluable patients in the ABPM substudy. ● Exclusion criteria 4, 10 and 24 relating to neurological cause for detrusor overactivity, QTcF interval (QT interval corrected using Fridericia’s correction formula) and urinary tract infection (UTI), respectively, were clarified. ● The list of prohibited or restricted medications was removed from Appendix 1 of the protocol and was provided to investigational sites via separate communications.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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