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    Clinical Trial Results:
    An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

    Summary
    EudraCT number
    		 2017-003294-33
    Trial protocol
    		 LV   HU   LT  
    Global end of trial date
    25 Jul 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Apr 2021
    First version publication date
    27 Jan 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Alignment with ClinicalTrials.gov record

    Trial information

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    Trial identification
    Sponsor protocol code
    RVT-901-3004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03583372
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Urovant Sciences GmbH
    Sponsor organisation address
    Viaduktstrasse 8 4051, Basel, Switzerland,
    Public contact
    Clinical Trial Information Contact, Urovant Sciences GmbH, 41 (42) 2155999, info@urovant.com
    Scientific contact
    Clinical Trial Information Contact, Urovant Sciences GmbH, 41 (42) 2155999, info@urovant.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
    26 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in subjects with overactive bladder (OAB) for up to 52 weeks.
    Protection of trial subjects
    Each investigator obtained approval of the study from a properly constituted Institutional Review Board (IRB), Research Ethics Board (REB), or Independent Ethics Committee (IEC) prior to study initiation. This study was conducted in compliance with Good Clinical Practice (GCP). Prior to participating in any study procedures, the study was discussed with each subject and/or with the subject’s legally authorized representative, and written informed consent was obtained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 506
    Worldwide total number of subjects
    506
    EEA total number of subjects
    0
    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)
    271
    From 65 to 84 years
    231
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 506 subjects with overactive bladder (OAB) who completed 12 weeks in Study RVT-901-3003 (NCT03492281) and were screened and randomized for this extension study, 505 received at least 1 dose of double-blind study drug (Safety Set Extension [SAF-Ext]: vibegron, N = 273; tolterodine, N = 232).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Assessor, Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 40 Weeks Vibegron 75 mg
    Arm description
    		 Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vibegron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vibegron 75-mg tablet, administered as a single tablet, orally, once daily

    Arm title
    		 52 Weeks Vibegron 75 mg
    Arm description
    		 Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vibegron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vibegron 75-mg tablet, administered as a single tablet, orally, once daily

    Arm title
    		 40 Weeks Tolterodine ER 4 mg
    Arm description
    		 Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tolterodine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tolterodine ER 4-mg capsule, administered as a single capsule, orally, once daily

    Arm title
    		 52 Weeks Tolterodine ER 4 mg
    Arm description
    		 Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tolterodine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tolterodine ER 4-mg capsule, administered as a single capsule, orally, once daily

    Number of subjects in period 1 [1]
    		40 Weeks Vibegron 75 mg 52 Weeks Vibegron 75 mg 40 Weeks Tolterodine ER 4 mg 52 Weeks Tolterodine ER 4 mg
    Started
    92
    181
    91
    141
    Completed
    79
    156
    72
    123
    Not completed
    13
    25
    19
    18
         Adverse event, serious fatal
    1
    -
    -
    -
         Captured As Other In The Database
    1
    2
    4
    1
         Subject Withdrawn Due To Sponsor
    -
    -
    -
    1
         Consent withdrawn by subject
    6
    11
    7
    8
         Physician decision
    -
    1
    1
    1
         Adverse event, non-fatal
    1
    3
    4
    4
         Lost to follow-up
    4
    6
    3
    2
         Lack of efficacy
    -
    1
    -
    1
         Protocol deviation
    -
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 506 subjects with overactive bladder (OAB) who completed 12 weeks in Study RVT- 901-3003 and were screened and randomized for this extension study, 505 received at least 1 dose of double-blind study drug (Safety Set Extension [SAF-Ext]). Baseline data are reported for members of the SAF-Ext.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    40 Weeks Vibegron 75 mg
    Reporting group description
    		 Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    52 Weeks Vibegron 75 mg
    Reporting group description
    		 Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    40 Weeks Tolterodine ER 4 mg
    Reporting group description
    		 Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    52 Weeks Tolterodine ER 4 mg
    Reporting group description
    		 Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group values
    		 40 Weeks Vibegron 75 mg 52 Weeks Vibegron 75 mg 40 Weeks Tolterodine ER 4 mg 52 Weeks Tolterodine ER 4 mg Total
    Number of subjects
    		 92 181 91 141 505
    Age categorical
    Units:
        < 40
    		 9 11 5 11 36
        ≥ 40 to < 55
    		 22 34 16 27 99
        ≥ 55 to < 65
    		 25 43 27 40 135
        ≥ 65 to < 75
    		 28 70 30 47 175
        ≥ 75
    		 8 23 13 16 60
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.8 ( 13.69 ) 62.1 ( 12.39 ) 62.1 ( 12.14 ) 60.6 ( 12.98 ) -
    Gender categorical
    Units: Subjects
        Female
    		 73 140 70 112 395
        Male
    		 19 41 21 29 110
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 0 0 2
        Asian
    		 4 16 8 11 39
        Black or African American
    		 14 23 10 26 73
        White
    		 72 141 72 102 387
        Other
    		 0 1 1 2 4
    Overactive Bladder (OAB) Type
    Urgency incontinence is the involuntary loss of urine accompanied by urgency (referred to as OAB Wet). In the absence of incontinence, OAB is referred to as OAB Dry.
    Units: Subjects
        Wet
    		 71 146 70 108 395
        Dry
    		 21 35 21 33 110

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    40 Weeks Vibegron 75 mg
    Reporting group description
    		 Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    52 Weeks Vibegron 75 mg
    Reporting group description
    		 Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    40 Weeks Tolterodine ER 4 mg
    Reporting group description
    		 Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    52 Weeks Tolterodine ER 4 mg
    Reporting group description
    		 Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Subject analysis set title
    Overall vibegron 75 mg: SAF-Ext Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Subjecs who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. The SAF-Ext is comprised of all subjects who received at least one dose of double-blind study treatment during RVT-901-3004.

    Subject analysis set title
    Overall tolterodine ER 4 mg: SAF-Ext Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received 40 weeks and 52 weeks tolterodine ER 4 mg. Subjects who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Subjects who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. The SAF-Ext is comprised of all subjects who received at least one dose of double-blind study treatment during RVT-901-3004.

    Subject analysis set title
    40 Weeks Vibegron 75 mg: FAS-Ext Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Full Analysis Set Extension (FAS-Ext) Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable change from Baseline (CFB) micturition measurement in this extension study.

    Subject analysis set title
    52 Weeks Vibegron 75 mg: FAS-Ext Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. FAS-Ext Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study.

    Subject analysis set title
    40 Weeks Tolterodine ER 4 mg: FAS-Ext Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. FAS-Ext Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study.

    Subject analysis set title
    52 Weeks Tolterodine ER 4 mg: FAS-Ext Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. FAS-Ext Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study.

    Subject analysis set title
    40 Weeks Vibegron 75 mg: FAS-Ext-I Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Full Analysis Set Extension for Incontinence (FAS-Ext-I) Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.

    Subject analysis set title
    52 Weeks Vibegron 75 mg: FAS-Ext-I Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. FAS-Ext-I Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.

    Subject analysis set title
    40 Weeks Tolterodine ER 4 mg: FAS-Ext-I Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. FAS-Ext-I Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.

    Subject analysis set title
    52 Weeks Tolterodine ER 4 mg: FAS-Ext-I Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. FAS-Ext-I Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.

    Primary: Number of Subjects with the Indicated Type of Treatment-emergent Adverse Event

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    End point title
    		 Number of Subjects with the Indicated Type of Treatment-emergent Adverse Event [1]
    End point description
    Adverse events were collected in subjects with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
    End point type
    Primary
    End point timeframe
    up to 56 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Overall vibegron 75 mg: SAF-Ext Population Overall tolterodine ER 4 mg: SAF-Ext Population
    Number of subjects analysed
    273
    232
    Units: subjects
    number (not applicable)
        Any TEAE
    171
    126
        Any study drug-related TEAE
    59
    46
        Any Grade ≥ 3 TEAE
    10
    8
        Any Grade ≥ 3 study drug-related TEAE
    1
    1
        Any treatment-emergent (TE) SAE
    9
    10
        Any study drug-related TE SAE
    1
    2
        Any TEAE leading to discontinuation of study drug
    4
    8
        Any TEAE of clinical interest
    41
    32
        Any study drug-related TEAE of clinical interest
    14
    10
    No statistical analyses for this end point

    Secondary: Change from Baseline (CFB) at Week 52 in the Average Number of Micturitions per 24 Hours in all Overactive Bladder (OAB) Subjects

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    End point title
    		 Change from Baseline (CFB) at Week 52 in the Average Number of Micturitions per 24 Hours in all Overactive Bladder (OAB) Subjects [2]
    End point description
    A micturition/void is defined as “Urinated in Toilet” as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a subject voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours” corresponds to one Diary Day (i.e., time between when the subject got up for the day each morning and time the subject got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 52
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis.
    End point values
    		 52 Weeks Vibegron 75 mg 52 Weeks Tolterodine ER 4 mg
    Number of subjects analysed
    152 [3]
    120 [4]
    Units: micturitions per 24 hours
        least squares mean (standard error)
    -2.4 ( 0.24 )
    -2.0 ( 0.26 )
    Notes
    [3] - Full Analysis Set Extension (FAS-Ext) Population. Only subjects with evaluable data were analyzed.
    [4] - FAS-Ext Population. Only subjects with evaluable data were analyzed.
    No statistical analyses for this end point

    Secondary: CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes per 24 Hours in OAB Wet Subjects

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    End point title
    		 CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes per 24 Hours in OAB Wet Subjects [5]
    End point description
    The number of UUI episodes is defined as the number of times a subject had checked “urge” as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to “urge” was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours” corresponds to one Diary Day (i.e., time between when subject got up for the day each morning and time subject got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only subjects with evaluable data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 52
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis.
    End point values
    		 52 Weeks Vibegron 75 mg 52 Weeks Tolterodine ER 4 mg
    Number of subjects analysed
    125 [6]
    91 [7]
    Units: UUI episodes per 24 hours
        least squares mean (standard error)
    -2.2 ( 0.15 )
    -1.7 ( 0.17 )
    Notes
    [6] - Full Analysis Set Extension for Incontinence (FAS-Ext-I) Population
    [7] - FAS-Ext-I Population
    No statistical analyses for this end point

    Secondary: CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) over 24 Hours in All OAB Subjects

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    End point title
    		 CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) over 24 Hours in All OAB Subjects [8]
    End point description
    The number of urgency episodes is defined as the number of times a subject had checked “need to urinate immediately” on a CDD divided by the number of CDDs in the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours” corresponds to one Diary Day (i.e., time between when the subject got up for the day each morning and time the subject got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 52
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis.
    End point values
    		 52 Weeks Vibegron 75 mg 52 Weeks Tolterodine ER 4 mg
    Number of subjects analysed
    152 [9]
    120 [10]
    Units: urgency episodes over 24 hours
        least squares mean (standard error)
    -3.4 ( 0.34 )
    -3.2 ( 0.37 )
    Notes
    [9] - FAS-Ext Population. Only subjects with evaluable data were analyzed.
    [10] - FAS-Ext Population. Only subjects with evaluable data were analyzed.
    No statistical analyses for this end point

    Secondary: CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes over 24 Hours in OAB Wet Subjects

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    End point title
    		 CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes over 24 Hours in OAB Wet Subjects [11]
    End point description
    The number of total incontinence episodes is defined as the number of times a subject had checked the accidental urine leakage box in the PVD, including for reasons of “urge,” “stress,” or “other.” CFB was calculated as the post-BL value minus the BL value. "Over 24 hours” corresponds to one Diary Day (i.e., time between when the subject got up for the day each morning and time the subject got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hours.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 52
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis.
    End point values
    		 52 Weeks Vibegron 75 mg 52 Weeks Tolterodine ER 4 mg
    Number of subjects analysed
    125 [12]
    91 [13]
    Units: Urinary incontinence episodes over 24 hr
        least squares mean (standard error)
    -2.5 ( 0.17 )
    -1.9 ( 0.19 )
    Notes
    [12] - FAS-Ext-I Population. Only subjects with evaluable data were analyzed.
    [13] - FAS-Ext-I Population. Only subjects with evaluable data were analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 56 weeks
    Adverse event reporting additional description
    Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all subjects who received at least one dose of double-blind study treatment during RVT-901-3004. Subjects were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Overall vibegron 75 mg
    Reporting group description
    		 Subjects who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Subjects who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Reporting group title
    Overall tolterodine ER 4 mg
    Reporting group description
    		 Subjects who received 40 weeks and 52 weeks tolterodine ER 4 mg. Subjects who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Subjects who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.

    Serious adverse events
    		 Overall vibegron 75 mg Overall tolterodine ER 4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 273 (3.30%)
    10 / 232 (4.31%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 273 (0.37%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    0 / 273 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 273 (0.37%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 273 (0.37%)
    0 / 232 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall vibegron 75 mg Overall tolterodine ER 4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 273 (23.81%)
    56 / 232 (24.14%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    24 / 273 (8.79%)
    20 / 232 (8.62%)
         occurrences all number
    25
    22
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 273 (5.49%)
    9 / 232 (3.88%)
         occurrences all number
    16
    9
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    5 / 273 (1.83%)
    12 / 232 (5.17%)
         occurrences all number
    5
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 273 (4.76%)
    12 / 232 (5.17%)
         occurrences all number
    16
    13
    Urinary tract infection
         subjects affected / exposed
    18 / 273 (6.59%)
    17 / 232 (7.33%)
         occurrences all number
    22
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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