Clinical trial NCT03583372
Conditions: Overactive Bladder
Keywords: Beta-3 adrenergic receptor (β3-AR) agonists incontinence OAB vibegron urge urinary incontinence Urinary bladder, overactive Urologic Diseases Lower Urinary Tract Symptoms Urological Agents
Sponsor: Urovant Sciences GmbH
Start date: 2018-06-14; Completion date: 2019-07-25
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vibegron intervention 2: placebos intervention 3: Tolterodine Tartrate ER
Intervention descriptions: intervention 1: single daily dose 75 mg intervention 2: placebo to match vibegron (experimental drug) and tolterodine (active comparator) intervention 3: single daily dose of 4 mg

Protocol documents:
Prot_000.pdf: 
Clinical Study Protocol 
RVT-901-3004 
Urovant Sciences GmbH 
Effective:  12-APR-2019 
Confidential 
Page | 1 
CLINICAL STUDY PROTOCOL 
Study Title: 
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 
Protocol Number: 
RVT-901-3004 
Compound Name and/or Number: Vibegron 
Indication 
Treatment of Overactive Bladder 
Sponsor: 
Urovant Sciences GmbH 
Viaduktstrasse 8 
4051 Basel  
Switzerland 
Development Phase: 
3 
Regulatory Identifier(s): 
IND# 106,410 
EudraCT# 2017-003294-33 
Current Version and Effective 
Date: 
Version 3.0 
12-APR-2019 
Previous Version(s) and Effective 
Date(s): 
Version 2.0 
06-FEB-2018 
Study Director: 
 
, Clinical Development 
Confidentiality Statement 
The information contained in this document, particularly unpublished data, is the property or under 
control of Urovant Sciences GmbH, and is provided to you in confidence as an investigator, potential 
investigator or consultant, for review by you, your staff, and an applicable Institutional Review Board or 
Independent Ethics Committee.  The information is only to be used by you in connection with authorized 
clinical studies of the investigational drug described in the protocol.  You will not disclose any of the 
information to others without written authorization from Urovant Sciences GmbH.  except to the extent 
necessary to obtain informed consent from those persons to whom the drug may be administered. 
NCT Number: NCT03583372
This NCT number has been applied to the document for
purposes of posting on clinicaltrials.gov


Clinical Study Protocol 
RVT-901-3004 
Urovant Sciences GmbH 
Effective:  12-APR-2019 
Confidential 
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SUMMARY OF CHANGES 
Version 
Location of Change 
Description of Change 
3.0 
Global 
Minor formatting, typographical, and grammatical errors were 
corrected. 
3.0 
Sponsor Signature Page The Sponsor signatory was changed from 
 to 
 
. 
3.0 
Medical 
Contact/Sponsor 
Information Page 
The secondary medical monitor was changed from 
 
 to 
. 
3.0 
Table of Contents; List 
of Tables, List of 
Figures 
Fields were updated. 
3.0 
1 
The approximate number of study sites was updated. 
3.0 
1; 5.1.1 
Reference to electronic completion of questionnaires was 
removed. 
3.0 
1; 3; 9.2.1 
A clarification was added that primary safety will assess adverse 
events that are treatment-emergent. 
3.0 
1; 3 
The endpoint categories of “Secondary Efficacy” and 
“Exploratory Efficacy” were renamed to “Secondary” and 
Exploratory”, respectively. 
3.0 
1; 3; 9.3.1 
The following endpoints previously included as “Secondary 
Efficacy” endpoints were moved to “Exploratory” endpoints. 
3.0 
1 
The statistical methods section was reordered with the sample size 
information appearing first. 


Clinical Study Protocol 
RVT-901-3004 
Urovant Sciences GmbH 
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Version 
Location of Change 
Description of Change 
3.0 
1; 9.3; 9.4.1; 9.4.2; 9.5; 
9.5.1; 9.6; former 9.8 
(removed) 
The description of statistical methods was revised in accordance 
with statistical analysis only being performed for the following 
4 secondary endpoints: 
• 
Change from baseline (CFB) at Week 52 in average number 
of micturitions per 24 hours in all OAB patients; 
• 
CFB at Week 52 in average number of urge urinary 
incontinence (UUI) episodes per 24 hours in OAB Wet 
patients; 
• 
CFB at Week 52 in average number of urgency episodes 
(need to urinate immediately) over 24 hours in all OAB 
patients; 
• 
CFB at Week 52 in average number of total urinary 
incontinence episodes over 24 hours in OAB Wet patients. 
All analysis will be considered descriptive only. 
3.0 
1.1 
A Week 12 physical exam was included in the Schedule of 
Activities. 
3.0 
1.1; 8.3.1 
Text was updated to indicate the collection period for adverse 
events and serious adverse events will begin following the first 
dose of Study Treatment in RVT-901-3004. 
3.0 
1.1; 8.3.1 
Phrasing was removed that limits the collection of adverse events 
to events “deemed related to study procedures” (all adverse events 
are recorded). 
3.0 
4.1 
The paragraphs in the study design section were reorganized to 
match the order in the synopsis. 
3.0 
6.4; 9.1 
Text on blinding was updated to reflect an updated blinding 
strategy for the study as double-blind, Sponsor open (partially 
unblinded). 
3.0 
7.7.1 
A clarification was added that all prior OAB meds should be 
assessed during prior medications review. 
3.0 
7.7.3 
A clarification was added that prohibition of medications with a 
narrow therapeutic index is specific only to the example drugs 
provided. 
3.0 
7.8; 9.3.1 
A clarification was added for the definition of “Complete Diary 
Day”. 
3.0 
8.3.3 
A clarification was added that overdose events that do not result 
in an adverse event will be reported as a protocol deviation in the 
eCRF. 
3.0 
1; 9.4 
“Extension” was added to analysis population names to 
distinguish analysis sets from this study versus RVT-901-3003. 
2.0 
Cover page 
Added Basel address; changed study director contact. 
2.0 
Global 
Minor typographical/grammatical errors were corrected. 


Clinical Study Protocol 
RVT-901-3004 
Urovant Sciences GmbH 
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Version 
Location of Change 
Description of Change 
2.0 
Medical 
Contact/Sponsor 
Information Page 
Update 
 to 
 and 
 to 
 to reflect new companies. 
2.0 
Table of Contents 
Updated all page numbers; Sections 5.4 and 5.4.1:  Replaced 
“Discontinuation” with “Interruption” and removed “Withdrawal 
from the Study”. 
2.0 
1; 3; 9.3.1 
Addition of two exploratory efficacy endpoints 
2.0 
1; 2.1 
Addition of (RVT-901) after Vibegron to align with Certificate of 
Analysis for product. 
2.0 
1; 3; 9.2.2; 9.3.1; 9.5.1 
 
2.0 
1.1 
Updated Schedule of Activities and visit events to reflect protocol 
text; updated and realigned footnotes accordingly. 
2.0 
5.4; 5.4.1 
Replaced “discontinuation” with “interruption”; reversed order of 
sentences. 
2.0 
6.6 
Removed study medication rechallenge in patients with a grade 3 
or higher drug-related AE reported. 
2.0 
7 
Moved Visit Reminders to 7.10. 
2.0 
7.8; 7.8.1 
Updates to Patient Voiding Diary instructions, training, and 
description. 
2.0 
7.9; 7.9.1; 7.9.2 
Updates to Urine Volume Collection instructions, training, and 
description. 
2.0 
7.10 
Update to instructions on Reminders for Diary Collection. 
2.0 
7.11; 7.11.1; 7.11.2 
Updates to Electronic Diary instructions and training. 
2.0 
8.3.1 
Updated and condensed section wording for Reporting Adverse 
Events. 
2.0 
8.6 
Updated MACCE language to match CAC Charter. 
2.0 
8.7 
Addition of timeframe around pregnancy and infant outcome. 
1.1 
Global 
Minor typographical/grammatical errors were corrected. 
1.1 
Sponsor Signature Page Minor wording update to sentence:  This protocol has been 
approved by a representative of Urovant Sciences GmbH. 
1.1 
1 
Wording in study design description changed from “at 
approximately 100 study sites” corrected to “at approximately 330 
study sites.”  


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RVT-901-3004 
Urovant Sciences GmbH 
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Version 
Location of Change 
Description of Change 
1.1 
1; 5.1.1 
Inclusion criterion #3 updated to reflect wording in Section 5.2.1. 
1.1 
1.1 
Footnotes were updated to include:  a note that paper diaries may 
be used with timing for their collection included; clarification that 
urinalysis will be performed if there is a positive dipstick result. 
1.1 
1.1 
eDiary completion for the Week 44 Visit was added. 
1.1 
5.2.1 
Changes were made to description of contraception requirements 
and methods for female patients 
1.1 
6.1 
“Tablet” or “capsule” descriptors were added to Table 6-1. 
1.1 
6.2 
Wording was added to indicate the study treatment should be 
swallowed whole. 
1.1 
7.2; 7.16 
Clarified that tablet/capsule count will be recorded in the 
interactive voice or web response system rather than case report 
form. 
1.1 
7.4 
The timing for collection of paper diaries (if used) was added. 
1.1 
7.4.4 
Removed reference to pharmacokinetic sampling as this is not 
performed in this extension study. 
1.1 
8.6 
Added adverse events suggestive of cystitis or urinary tract 
infection and moved liver test values to end of list. 
 




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Urovant Sciences GmbH 
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MEDICAL CONTACT/SPONSOR INFORMATION PAGE 
Sponsor Medical Contact/Serious Adverse Event Contact Information: 
Role 
Name 
Day Time 
After-Hours 
Primary 
Medical 
Monitor 
Office: 
Mobile:
Fax:  
 
E-mail:  
 
Office: 
Mobile:
Fax:  
 
E-mail:  
 
Secondary
Medical 
Monitor 
Mobile:  
 
E-mail:  
Mobile:  
 
E-mail:  
 
Contact for Serious 
Adverse Events (SAEs) 
Email:  
 
Phone:  
 
Fax:  
 
 
 
Study Sponsor: 
This study is sponsored by Urovant Sciences GmbH. 
 


Clinical Study Protocol 
RVT-901-3004 
Urovant Sciences GmbH 
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INVESTIGATOR STATEMENT 
• I confirm agreement to conduct the study in compliance with the protocol. 
• I acknowledge that I am responsible for overall study conduct.  I agree to personally 
conduct or supervise the described study. 
• I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study understand their obligations and will comply with the study 
protocol.  Mechanisms are in place to ensure that site staff receives the appropriate 
training and information throughout the study. 
 
 
 
 
Principal Investigator Name (Printed) 
 
Signature 
 
 
 
Date 
 
Site 
 


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TABLE OF CONTENTS 
SUMMARY OF CHANGES ...........................................................................................................2 
SPONSOR SIGNATURE PAGE ....................................................................................................6 
MEDICAL CONTACT/SPONSOR INFORMATION PAGE ........................................................7 
INVESTIGATOR STATEMENT ...................................................................................................8 
TABLE OF CONTENTS .................................................................................................................9 
LIST OF TABLES .........................................................................................................................13 
LIST OF FIGURES .......................................................................................................................13 
1. 
SYNOPSIS .................................................................................................................14 
1.1. 
Schedule of Activities .................................................................................................20 
2. 
INTRODUCTION ......................................................................................................24 
2.1. 
Indication ....................................................................................................................24 
2.2. 
Background .................................................................................................................24 
2.3. 
Study Rationale ...........................................................................................................25 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................26 
4. 
INVESTIGATIONAL PLAN .....................................................................................28 
4.1. 
Overall Study Design ..................................................................................................28 
4.2. 
Treatment Arms and Duration ....................................................................................30 
4.3. 
Number of Participants ...............................................................................................30 
4.4. 
Definition of Study Completion by a Patient .............................................................30 
4.5. 
End of Study Definition ..............................................................................................30 
5. 
STUDY POPULATION .............................................................................................31 
5.1. 
Eligibility Criteria .......................................................................................................31 
5.1.1. 
Inclusion Criteria ........................................................................................................31 
5.1.2. 
Exclusion Criteria .......................................................................................................31 
5.2. 
On-Study Restrictions .................................................................................................33 
5.2.1. 
Contraception ..............................................................................................................33 
5.2.2. 
Meals and Dietary Restrictions ...................................................................................33 
5.3. 
Screen Failure .............................................................................................................34 
5.4. 
Interruption of Study Treatment .................................................................................34 
5.4.1. 
Temporary Interruption ..............................................................................................34 
5.4.2. 
Rechallenge .................................................................................................................34 


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Urovant Sciences GmbH 
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5.5. 
Withdrawal from the Study ........................................................................................34 
5.6. 
Lost to Follow Up .......................................................................................................35 
5.7. 
Early Study Termination .............................................................................................35 
6. 
STUDY TREATMENT ..............................................................................................36 
6.1. 
Study Treatments Description ....................................................................................36 
6.2. 
Administration of Study Treatments ..........................................................................36 
6.3. 
Study Treatment Assignment .....................................................................................36 
6.4. 
Blinding ......................................................................................................................37 
6.4.1. 
Unblinding ..................................................................................................................37 
6.5. 
Dose Modification ......................................................................................................37 
6.6. 
Treatment Discontinuation and Rechallenge ..............................................................37 
6.7. 
Packaging and Labeling ..............................................................................................38 
6.8. 
Preparation/Handling/Storage/Accountability ............................................................38 
6.9. 
Study Treatment Compliance .....................................................................................38 
6.10. 
Study Treatment Overdose .........................................................................................38 
6.11. 
Treatment after the End of the Study ..........................................................................39 
7. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................40 
7.1. 
Order of Assessments .................................................................................................40 
7.2. 
Scheduling Visits ........................................................................................................40 
7.3. 
Unscheduled Visits .....................................................................................................40 
7.4. 
Assignment of Patient Number ...................................................................................40 
7.5. 
Informed Consent .......................................................................................................40 
7.6. 
Inclusion/Exclusion Criteria .......................................................................................41 
7.7. 
Prior and Concomitant Medications ...........................................................................41 
7.7.1. 
Prior Medications ........................................................................................................41 
7.7.2. 
Concomitant Medications ...........................................................................................41 
7.7.3. 
Prohibited Medications and Non-Drug Therapies ......................................................42 
7.7.4. 
Permitted Medications and Non-Drug Therapies .......................................................43 
7.7.5. 
Requirements for Use of Stable Therapies .................................................................43 
7.8. 
Patient Voiding Diary .................................................................................................44 
7.8.1. 
Patient Voiding Diary Training/Re-Training..............................................................44 
7.9. 
Urine Volume Diary ...................................................................................................44 
7.9.1. 
Urine Volume Collection Training/Re-Training ........................................................45 


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7.9.2. 
Dispense Urine Collection and Measurement Supplies ..............................................45 
7.10. 
Reminders for Diary Collection ..................................................................................45 
7.11. 
Electronic Diary ..........................................................................................................45 
7.11.1. 
eDiary Device Set-Up and Training ...........................................................................46 
7.11.2. 
Device Training/Re-Training ......................................................................................46 
7.12. 
Patient-Reported Outcomes ........................................................................................46 
7.13. 
Post-Void Residual Volume .......................................................................................47 
7.14. 
Physical Examination .................................................................................................47 
7.15. 
Electrocardiogram .......................................................................................................47 
7.16. 
Vital Signs ..................................................................................................................47 
7.17. 
Adverse Events ...........................................................................................................48 
7.18. 
Clinical Laboratory Assessments ...............................................................................48 
7.18.1. 
Chemistry, Hematology, and Urinalysis (Laboratory Safety Evaluations) ................48 
7.18.2. 
Urine β-hCG ...............................................................................................................50 
7.19. 
IxRS Randomization to Study Treatment ...................................................................50 
7.20. 
Dispense Double-Blind Study Treatment ...................................................................50 
7.21. 
Study Treatment Return/Accountability Review ........................................................50 
7.22. 
Follow-up Visit ...........................................................................................................50 
8. 
SAFETY CONSIDERATIONS ..................................................................................51 
8.1. 
Definition of an Adverse Event ..................................................................................51 
8.2. 
Definition of a Serious Adverse Event .......................................................................52 
8.3. 
Adverse Event Reporting ............................................................................................53 
8.3.1. 
Period for Reporting Adverse Events .........................................................................54 
8.3.2. 
Reporting Serious Adverse Events .............................................................................54 
8.3.3. 
Study Treatment Overdose Management ...................................................................55 
8.4. 
Assigning Causal Relationship to Study Treatment ...................................................55 
8.5. 
Assigning Severity Rating for Adverse Events ..........................................................56 
8.6. 
Adverse Events of Clinical Interest ............................................................................56 
8.6.1. 
Criteria for Temporary Withholding of Study Treatment in Association with 
Liver Test Abnormalities ............................................................................................57 
8.6.2. 
Criteria for Permanent Discontinuation of Study Treatment in Association 
with Liver Test Abnormalities ....................................................................................58 
8.7. 
Pregnancy Management and Reporting to the Sponsor ..............................................59 


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8.8. 
Benefit/Risk Assessment ............................................................................................59 
9. 
STATISTICAL CONSIDERATIONS .......................................................................60 
9.1. 
Responsibility for Analyses/In-House Blinding .........................................................60 
9.2. 
Hypotheses ..................................................................................................................60 
9.2.1. 
Primary Objective and Hypotheses ............................................................................60 
9.2.2. 
Secondary Objectives .................................................................................................60 
9.3. 
Analysis Endpoints .....................................................................................................61 
9.3.1. 
Efficacy Endpoints ......................................................................................................61 
9.3.2. 
Safety Endpoints .........................................................................................................63 
9.4. 
Analysis Populations...................................................................................................63 
9.4.1. 
Efficacy Analysis Populations ....................................................................................63 
9.4.2. 
Safety Analysis Populations .......................................................................................64 
9.5. 
Statistical Methods ......................................................................................................64 
9.5.1. 
Statistical Methods for Efficacy Analyses ..................................................................64 
9.5.2. 
Statistical Methods for Safety Analyses .....................................................................65 
9.6. 
Multiplicity .................................................................................................................65 
9.7. 
Sample Size Determination ........................................................................................65 
9.8. 
Interim Analyses .........................................................................................................65 
10. 
STUDY GOVERNANCE CONSIDERATIONS .......................................................66 
10.1. 
Financial Disclosure ...................................................................................................66 
10.2. 
Data Management .......................................................................................................66 
10.3. 
Monitoring ..................................................................................................................66 
10.4. 
Auditing or Inspections ...............................................................................................67 
10.5. 
Study Oversight Committees ......................................................................................67 
10.5.1. 
Clinical Adjudication Committee ...............................................................................67 
10.5.2. 
Steering Committee ....................................................................................................67 
10.6. 
Protocol Modifications ...............................................................................................67 
10.7. 
Study Discontinuation ................................................................................................68 
10.8. 
Publications .................................................................................................................68 
10.9. 
Investigator-Specific Responsibilities ........................................................................68 
10.9.1. 
Compliance with Regulations and Ethical Standards .................................................68 
10.9.2. 
Protocol Compliance ..................................................................................................68 
10.9.3. 
Institutional Review Board/Independent Ethics Committee Requirements ...............69 


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10.9.4. 
Informed Consent .......................................................................................................69 
10.9.5. 
Confidentiality ............................................................................................................70 
10.9.6. 
Study Files and Retention of Records ........................................................................70 
10.9.7. 
Electronic Case Report Forms ....................................................................................71 
10.9.8. 
Investigational Product Accountability ......................................................................71 
10.10. 
Sponsor-Specific Responsibilities ..............................................................................72 
10.10.1. 
Study Report ...............................................................................................................72 
10.10.2. 
Posting of Information on Publicly Available Clinical Trial Registers ......................72 
11. 
REFERENCES ...........................................................................................................73 
APPENDICES ...............................................................................................................................75 
APPENDIX 1. LIST OF ABBREVIATIONS ............................................................................76 
APPENDIX 2. ALGORITHM FOR ASSESSING LABORATORY VALUES ........................79 
APPENDIX 3. APPROXIMATE BLOOD/TISSUE VOLUMES 
DRAWN/COLLECTED BY SAMPLE TYPE ..........................................................80 
APPENDIX 4. GUIDELINES FOR ELEVATIONS IN HEPATIC ENZYMES .......................81 
 
LIST OF TABLES 
Table 1 
RVT-901-3004 Schedule of Activities .......................................................................20 
Table 2 
RVT-901-3004 Study Treatments ..............................................................................36 
Table 3 
Listing of Prohibited Medications ..............................................................................42 
Table 4 
Laboratory Tests .........................................................................................................49 
Table 5 
Criteria for Determining the Grade/Severity of Adverse Event Terms ......................56 
 
LIST OF FIGURES 
Figure 1 
RVT-901-3004 Study Schematic ................................................................................29 
 


Clinical Study Protocol 
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1. 
SYNOPSIS 
Study Title 
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 
Protocol Number 
RVT-901-3004 
Study Center 
Location(s) 
International 
Number of Study 
Centers Planned 
~110 
Study Phase 
3 
Target Population 
Adult men and women with either: 
• Overactive bladder (OAB) Wet; or 
• OAB Dry 
Number of Patients 
Planned 
500 
Study Objectives 
 
Primary Safety 
Objective 
• To evaluate the safety and tolerability of vibegron (RVT-901) for up to 52 
weeks in patients with symptoms of overactive bladder (OAB) who 
previously completed treatment in study RVT-901-3003 
Secondary and 
Exploratory 
Objectives 
• To evaluate the efficacy of vibegron in patients with symptoms of OAB 
Study Design 
This is an international Phase 3, double-blind, active (tolterodine)-controlled, 
parallel-group, multicenter, 40-week extension study to evaluate the safety, 
tolerability, and efficacy of vibegron 75 mg in men and women with symptoms of 
overactive bladder syndrome (OAB).  This study is an extension for patients who 
have completed the Phase 3, double-blind, randomized, 12-week study RVT-901-
3003. 
Approximately 500 men and women with overactive bladder who completed 
12 weeks in study RVT-901-3003 will be permitted to enroll in this extension 
study, at approximately 110 study sites. 
During this extension study, all patients who had been randomized in 
RVT-901-3003 to receive either vibegron 75 mg or tolterodine ER 4 mg will 
continue their same treatment once daily in a blinded fashion for an additional 
40 weeks; patients who had been randomized in RVT-901-3003 to the placebo 
group will be randomized 1:1 to receive blinded study treatment of vibegron 
75 mg or tolterodine ER 4 mg once daily for 40 weeks during the extension.  
Thus, through participation in both the RVT-901-3003 study and the RVT-901-
3004 (extension) study, patients originally randomized to vibegron or tolterodine 
will receive 52 weeks total of vibegron or tolterodine treatment, and patients 
originally randomized to placebo will receive 40 weeks total of vibegron or 
tolterodine treatment. 


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Study visits will be named to reflect continuation from the RVT-901-3003 study, 
with the first study visit of this extension study occurring at Study Treatment 
Week 12.  Following enrollment in this extension study, patients will return to the 
clinic for visits at Week 16, Week 24, Week 36, Week 44, and Week 52 (all 
relative to Day 1 of RVT-901-3003).  The Schedule of Activities (Section 1.1) 
summarizes the assessments/procedures to be performed at each visit. 
This study consists of a randomized double-blind Treatment Period (40 weeks), 
and a Safety Follow-up Period (4 weeks).  All patients will have a Follow-up Visit 
approximately 28 days after the patient’s last dose of study treatment (i.e., at 
Week 56 for patients who complete the Week 52 Visit, or approximately 4 weeks 
after withdrawal for patients who discontinue the study early).  Additionally, 
unscheduled follow-up visit(s) may be arranged for patients with study-related 
safety concerns as needed. 
Study Treatments 
The investigator, site staff, and the patients will remain blinded to the Study 
Treatment during this extension study. 
All treatments are dosed orally, once daily (QD).  Patients will receive one of the 
following blinded treatments: 
• Vibegron 75 mg tablet + placebo capsule to match tolterodine ER 
4 mg capsule (N = 267) 
• Tolterodine ER 4 mg capsule + placebo tablet to match vibegron 75 mg tablet 
(N = 233) 
All patients previously randomized to placebo in RVT-901-3003 will be 
randomized 1:1 to receive vibegron 75 mg tablet + placebo capsule to match 
tolterodine ER 4 mg capsule or tolterodine ER 4 mg capsule + placebo tablet 
to match vibegron 75 mg tablet, in this extension study. 
Duration of 
Treatment 
40 weeks 
Note:  upon entering this extension study, all patients will have already received 
2 weeks of treatment with placebo plus an additional 12 weeks of treatment with 
vibegron, tolterodine, or placebo in the RVT-901-3003 study. 
Eligibility Criteria 
 
Inclusion Criteria 
1. Has completed participation in study RVT-901-3003. 
2. Willing and able to provide written informed consent. 
3. For females of reproductive potential:  Agrees to remain abstinent or use (or 
have their male partner use) an acceptable method of birth control (as 
defined in Section 5.2.1) each time the patient has intercourse until the 
Follow-up Visit. 
4. For females of reproductive potential:  Agrees not to donate ova (eggs) until 
at least 1 month after the last dose of Study Treatment. 
5. Has demonstrated ≥ 80% compliance with self-administration of Study 
Treatment in study RVT-901-3003. 
6. Has completed a minimum of 4 Complete Diary Days for study RVT-901-
3003 Week 12. 


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7. Is ambulatory and in good general physical and mental health as determined 
by the Investigator. 
8. In the opinion of the Investigator, is able and willing to comply with the 
requirements of the protocol, including completing questionnaires, the 
Voiding Diary, and Voided Volume Diary (will require ability to collect, 
measure, and record voided volume by herself/himself using a graduated 
urine collection and measurement container [provided by the Sponsor, if 
needed]). 
Exclusion Criteria 
1. Was unable to complete participation in study RVT-901-3003 for any 
reason. 
2. Has a change in history or current evidence of any clinically significant 
condition, therapy, lab abnormality, or other circumstance that might, in the 
opinion of the Investigator, confound the results of the study, interfere with 
the patient’s ability to comply with study procedures, or make participation 
in the study not in the patient’s best interest.  Includes any serious or 
unstable, clinically relevant change in gastrointestinal, renal, hepatic, 
cardiovascular, lymphatic, or psychiatric, or other medical disorder during 
the RVT-901-3003 study 
3. Has coronary or neurovascular interventions planned during the duration of 
the study. 
4. Has uncontrolled hyperglycemia (defined as fasting blood glucose 
>150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL 
or 11.1 mmol/L) based on most recent available lab results in study RVT-
901-3003 or, if in the opinion of the Investigator, is uncontrolled. 
5. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg 
and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate 
(by pulse) > 100 beats per minute. 
a. Patients who have systolic blood pressures ≥ 160 mm Hg or 
< 180 mm Hg are excluded, unless deemed by the Investigator and/or 
Medical Monitor as safe to proceed in this study and able to complete 
the study per protocol; these patients must be on stable hypertension 
medication for at least 90 days. 
b. All patients with signs and symptoms of uncontrolled hypertension, 
regardless of blood pressure measurement, are excluded from the 
study.  These include, but are not limited to neurological symptoms or 
findings, hematuria, proteinuria, retinopathy, unstable angina, acute 
heart failure. 
6. Has clinically significant ECG abnormality which, in the opinion of the 
Investigator, exposes the patient to risk by participating in the study  
7. Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the 
upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or 
> 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with 


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Gilbert syndrome) based on most recent available lab results in study RVT-
901-3003. 
8. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 
based on most recent available lab results in study RVT-901-3003. 
9. Use of any prohibited medications as detailed in Section 7.7.3. 
10. Plans to initiate or change the dosing of any medications listed in 
Section 7.7.5 during the study that in the opinion of the investigator is 
assessed to be clinically significant. 
11. Has an allergy, intolerance, or a history of a significant clinical or laboratory 
adverse experience associated with any of the active or inactive components 
of the vibegron formulation or tolterodine formulation. 
12. Is currently participating or has participated in a study with an 
investigational compound or device within 28 days of signing informed 
consent, not including participation in study RVT-901-3003. 
13. Has a history of significant drug or alcohol abuse/dependence within a year 
of informed consent, as assessed by the investigator. 
14. Has a varying sleep schedule anticipated during times when the voiding 
diaries are to be completed. 
Endpoints 
 
Primary Safety 
• Incidence of any treatment-emergent adverse event by system organ class and 
preferred term 
Secondary 
Endpoints 
• Change from baseline (CFB) at Week 52 in average number of micturitions 
per 24 hours in all OAB patients 
• CFB at Week 52 in average number of urge urinary incontinence (UUI) 
episodes per 24 hours in OAB Wet patients 
• CFB at Week 52 in average number of urgency episodes (need to urinate 
immediately) over 24 hours in all OAB patients 
• CFB at Week 52 in average number of total urinary incontinence episodes 
over 24 hours in OAB Wet patients 
Exploratory 
Endpoints 


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Statistical Methods  
Sample Size 
Estimation 
Five hundred (500) patients rolling over from study RVT-901-3003, in addition to 
other long-term safety data with vibegron, is sufficient to characterize the long-
term safety profile of vibegron 75 mg once daily and satisfies the International 
Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) guidance for 1-year exposure. 
Safety 
Safety assessments will include treatment-emergent adverse events, clinical 
laboratory tests, physical examinations, vital signs, and 12-lead ECGs.  Safety 
analyses will be based on all patients who receive any amount of blinded study 
drug (through Week 52 of this extension study).  Two treatment groups will be 
used for reporting of safety data and will be determined based on randomized 
treatment in RVT-901-3004.  Baseline will be the RVT-901-3003 baseline. 
Descriptive statistics will be used to summarize safety endpoints.  No formal 
statistical comparisons will be performed. 
Efficacy 
The efficacy analyses will be for descriptive purposes only and will be conducted 
using the FAS-Extension population, which is a subset of the RVT-901-3003 
treated population who have completed the 12-week treatment period in RVT-
901-3003 and enrolled into this extension study. 
The efficacy endpoints of change from baseline in average number of micturitions, 
average number of UUI episodes, average number of urgency episodes, and 
average number of total incontinence episodes will be analyzed separately using a 
mixed model for repeated measure (MMRM) with restricted maximum likelihood 
estimation.  The analysis model for each efficacy endpoint will include terms for 
treatment, visit, baseline stratification factors (those found to be significant in 
RVT-901-3003), baseline score, and interaction of visit by treatment.  An 
unstructured covariance matrix will be used to model the correlation among 
repeated measurements.  The Kenward-Roger adjustment will be used with 
restricted (or residual) maximum likelihood (REML) to make statistical inference.  
Adjusted means for each treatment group and visit will be estimated along with 
95% confidence intervals.  No formal statistical comparisons will be made.  Only 
the 52-week subjects (those on active treatment in RVT-901-3003 and in 
RVT-901-3004) will be included in the model. 
Descriptive statistics will be used to summarize all efficacy endpoints.  Summaries 
of efficacy endpoints will be presented by treatment group where the 4 treatment 
groups will be determined by randomized treatment in both RVT-901-3003 and 
RVT-901-3004.  Baseline will be the RVT-901-3003 baseline. 


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1.1. 
Schedule of Activities 
Table 1 
RVT-901-3004 Schedule of Activities 
Study Period: 
 
Treatment 
Safety Follow-up/ 
Unscheduled 
Visit Number: 
Visit #6 
Visit #7 
Visit #8 
Visit #9 
Visit #10 
Visit #11 
UNS # 
Visit #12 
Visit Name: 
Week 12 
Week 16 
Week 24 
Week 36 
Week 44 
Week 52 
or Early WD 
Unsch-
eduled23 
Follow-
up24 
Study Day: 
85 
113 
169 
253 
308 
365 
 
393 or 
WD + 28 
Permitted Visit Window: 
± 3 Days 
± 3 Days 
± 3 Days 
± 3 Days 
± 3 Days 
± 3 Days 
 
± 3 Days 
Informed Consent 
X1 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria Eligibility Review 
X1 
 
 
 
 
 
 
 
Electronic Diary (eDiary) 2: 
 
 
 
 
 
 
 
 
eDiary Device 
 
 
 
 
 
 
 
 
Device Function Check4 
X3 
X 
X 
X 
X 
X 
X 
 
Device Re-Training5 
X1 
X 
X 
X 
X 
 
X 
 
Collect eDiary Device 
 
 
 
 
 
X 
 
 
Patient Voiding Diary: 
 
 
 
 
 
 
 
 
Voiding Diary Re-Training6 
X1 
X 
X 
 
X 
X 
X 
 
Patient Completes Voiding Diary7 
X* 
X 
X 
 
X 
X 
 
 
Urine Volume Diary: 
 
 
 
 
 
 
 
 
Voided Volume Diary Re-Training6 
X1 
X 
X 
 
X 
X 
X 
 
Patient Completes Voided Volume Diary8 
X* 
X 
X 
 
X 
X 
 
 
Diary and Visit Reminders 
 
 
 
 
 
 
 
 
Phone Calls/ Optional SMS reminders9 
X* 
X 
X 
 
X 
X 
 
 
Patient Reported Outcomes (PROs)10: 
 
 
 
 
 
 
 
 
Global Impression Items (PGI-Severity, PGI-Control, 
PGI-Frequency, PGI-Leakage, and PGI-Change) 
X* 
 
X 
 
 
X 
 
 
Overactive Bladder Questionnaire (OAB-q LF) 
X* 
 
X 
 
 
X 
 
 
Work Productivity and Activity Impairment 
Questionnaire-Urinary Symptoms (WPAI-US) 
X* 
 
X 
 
 
X 
 
 
EQ-5D 
X* 
 
X 
 
 
X 
 
 
Post-Void Residual (PVR) Volume11 
X* 
 
X 
 
 
X 
 
 
Physical Exam12 
X1 
 
 
 
 
 
X 
X 
ECG13 
X1 
 
 
 
 
 
X 
 
Vital Signs14 
X* 
X 
X 
X 
X 
X 
X 
X 


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Study Period: 
 
Treatment 
Safety Follow-up/ 
Unscheduled 
Visit Number: 
Visit #6 
Visit #7 
Visit #8 
Visit #9 
Visit #10 
Visit #11 
UNS # 
Visit #12 
Visit Name: 
Week 12 
Week 16 
Week 24 
Week 36 
Week 44 
Week 52 
or Early WD 
Unsch-
eduled23 
Follow-
up24 
Study Day: 
85 
113 
169 
253 
308 
365 
 
393 or 
WD + 28 
Permitted Visit Window: 
± 3 Days 
± 3 Days 
± 3 Days 
± 3 Days 
± 3 Days 
± 3 Days 
 
± 3 Days 
Adverse Event Review15 
==============================================================================➔ 
Serious Adverse Events16 
==============================================================================➔ 
Concomitant Medication Review17 
==============================================================================➔ 
Clinical Laboratory Assessments: 
 
 
 
 
 
 
 
 
Chemistry 
X* 
X 
X 
 
 
X 
X 
X 
Hematology 
X* 
X 
X 
 
 
X 
X 
X 
Urine Dipstick18 
X* 
X 
X 
 
 
X 
X 
X 
Urine Pregnancy -hCG (women)19 
X* 
X 
X 
X 
X 
X 
X 
X 
IxRS Randomization to Study Treatment 
X1 
 
 
 
 
 
 
 
Dispense Study Treatment20 
X1 
X 
X 
X 
X 
 
X 
 
Study Treatment Return/Accountability Review21 
X* 
X 
X 
X 
X 
X 
 
 
Administer Witnessed Dose of Study Treatment22 
X1 
 
 
 
 
 
 
 
Abbreviations:  IxRS, interactive voice or web response system; WD, withdrawal; β-hCG, β-human chorionic gonadotropin 
 
Table Footnotes: 
Week 12 
1. Patients continuing from the RVT-901-3003 study at Week 12 require additional study procedures for the RVT-901-3004 extension 
study. 
* Activities collected at Week 12 Visit in RVT-901-3003. 
Electronic Diary (eDiary) 
2. The Electronic Diary (eDiary) for this study includes both the Patient Voiding Diary and the Urine Volume Diary, and will be 
implemented via an eDiary device (provisioned smartphone).  A paper diary will be provided to all patients to be used as a back-up 
when necessary.  If a back-up paper diary is used, it should be collected at the next visit. 
3. The site will update the Subject Status Screen on the eDiary to move the patient to the RVT-901-3004 extension study. 


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eDiary Device 
4. At each visit during the Treatment Period, site personnel will confirm that the eDiary Device is functioning properly. 
5. Specific re-training on device operation will be provided to the patient at each visit. 
Patient Voiding Diary and Urine Volume Diary 
6. Specific re-training on completion of the Voiding Diary and Voided Volume Diary will be provided to the patient at each visit. 
7. The Voiding Diary should be completed by the patient on all of the 7 Diary Days prior to the Week 16, 24, 44, and 52 Visits.  Patient 
will receive an alert and/or phone call reminder to complete the diary. 
8. The Voided Volume collection and Voided Volume Diary completion should be performed by the patient on one (1) of the 7 Diary 
Days prior to the Weeks 16, 24, 44, and 52 Visits. 
Diary and Visit Reminders 
9. Patient will receive phone call reminders from the site to complete the Diary on approximately the first day and third day of each diary 
collection period (or next business day).  Patient may consent to additional SMS Text reminders (where available). 
Patient Reported Outcomes (PROs) 
10. Vital signs, followed by PRO Questionnaires, will be the first procedure performed at visits that include PRO administration.  
Questionnaires will be administered on paper at the site in the order listed in the Schedule of Activities. 
Post Void Residual Volume 
11. All efforts will be made to ensure the same device and operator are used for all PVR volume measurements for individual patients (in 
study RVT-901-3003 and RVT-901-3004). 
Physical/ECG/Vitals 
12. A Complete Physical Exam will be performed at the Follow-up Visit. 
13. A single 12-lead ECG will be obtained at Week 12. 
14. Vital Signs includes Blood Pressure (average of three measurements taken 1-2 minutes apart after sitting for 5 min), Heart Rate, 
Temperature, Respiration Rate, and Weight. 
Adverse Events 
15. Adverse Events will be collected from the time a patient takes the first dose of Study Treatment in the RVT-901-3004 study until the 
Follow-up Visit is completed. 


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16. Serious Adverse Events will be collected from the time a patient takes the first dose of Study treatment in the RVT-901-3004 study until 
the Follow-up Visit is completed. 
Concomitant Medications 
17. Concomitant medications from RVT-901-3003 will be reviewed and confirmed to be stable.  Concomitant medications will be recorded 
at each study visit and at any Unscheduled Visits. 
Labs 
18. At Weeks 36 and 44, the Urine Dipstick will only be performed if clinically indicated (e.g., symptoms of urinary retention or urinary 
tract infection).  Urinalysis will be performed only if the urine dipstick tests positive for the presence of leukocytes, nitrites, or blood 
cells, and will be performed by the central lab. 
19. Urine beta-human chorionic gonadotropin (β-hCG) will be tested for women of childbearing potential only. 
Dosing/Drug 
20. Dosing will occur every day from the Witnessed Dose on the day of the Week 12 Visit through the day before the Week 52 Visit. 
21. Study Treatment bottles should be returned by the patient at each visit.  Clinic staff will perform accountability and review any 
discrepancies with the patient during the visit. 
22. All patients will take their dose of Study Treatment on the day of the Week 12 Visit at the site as a witnessed dose.  The date and time 
of Study Treatment dosing will be recorded. 
Follow-up/Unscheduled 
23. Unscheduled Visits and the specific procedures performed at these visits will be determined by the Investigator, as clinically indicated.  
The procedures indicated in the Schedule of Activities will be performed at these visits, as clinically indicated, based on the purpose of 
the visit (e.g., follow-up for an adverse event or abnormal laboratory test, dispense study treatment medication).  The reason for the visit 
will be captured in the source documents. 
24. For patients who complete the study or who Withdraw from the study early for any reason, a Follow-up Visit should be performed 
approximately 28 days after the last dose of Study Treatment (on Study Day 393 or approximately 28 days after a patient’s Withdrawal 
from the study).  When a patient withdraws from the study prior to study completion, all applicable activities scheduled for the Week 52 
Visit should be performed at the time of withdrawal. 


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2. 
INTRODUCTION 
2.1. 
Indication 
Vibegron (RVT-901) is currently in development to reduce urge urinary incontinence, urgency, 
and urinary frequency in patients with overactive bladder (OAB). 
2.2. 
Background 
OAB affects approximately 16% of the population in the US and EU.  Prevalence increases with 
age, affecting approximately 1/3 of people 75 years and older [Stewart, 2003; Milsom, 2001].  
The International Continence Society (ICS) defines OAB as urgency, with or without urge 
incontinence, usually associated with frequency and nocturia [Abrams, 2002].  Urgency is 
defined as a sudden compelling desire to void which is difficult to defer.  Urge urinary 
incontinence (UUI) is the involuntary loss of urine accompanied by urgency (referred to as OAB 
Wet) and is present in approximately one-third of patients with OAB [Stewart, 2003; 
Milsom, 2001].  In the absence of incontinence, OAB is referred to as OAB Dry.  UUI is 
distinguished from stress urinary incontinence, which is the involuntary loss of urine on effort or 
physical exertion (e.g., sporting activities), or on sneezing or coughing.  When both components 
are present, the classification is mixed urinary incontinence and the Investigator will make a 
determination of either urgency or stress specified as the predominant component. 
Currently, the predominant class of drugs used to treat OAB is antimuscarinics.  The clinical use 
of antimuscarinics is limited by modest efficacy and poor tolerability due to mechanism-based 
side effects including dry mouth, constipation, and the potential for CNS adverse effects (e.g., 
cognitive impairment).  High discontinuation rates have been observed for both tolterodine and 
oxybutynin, two commonly prescribed antimuscarinics, in both clinical trials and marketed 
settings [D’Souza, 2008; Lawrence, 2000].  In a study evaluating the discontinuation rate of new 
prescriptions for tolterodine ER or oxybutynin, the mean time to discontinuation was 45 to 
60 days, and over 55% of patients never refilled their original prescription [Lawrence, 2000].  At 
six months, less than 1/3 of patients were still refilling their prescriptions.  The lack of efficacy 
or inability to tolerate antimuscarinics leaves patients with few alternative treatment options.  As 
such, there is a clear unmet medical need for better treatment options for patients with OAB.  In 
addition, recent evidence from observational studies suggests that higher cumulative 
anticholinergic use is associated with an increased risk of dementia [Gray, 2015; Gray, 2016]. 
Beta-3 adrenergic receptor (β3-AR) agonists demonstrated efficacy in alleviating symptoms of 
OAB [Chapple, 2009; Chapple, 2010; Chapple, 2012].  To date, one β3-AR agonist, mirabegron 
(Astellas Pharma Global Development, Inc.), has received marketing approval in Japan and the 
United States for the treatment of OAB.  Reductions in micturition frequency, urinary 
incontinence and urgency episodes, and increases in mean volume voided per micturition were 
observed with mirabegron [Chapple, 2009; Chapple, 2010; Chapple, 2012].  Cross-study 
comparisons of the clinical profiles of β3-AR agonists with the antimuscarinic, DETROL® LA 
(tolterodine tartrate extended release, hereafter referred to as tolterodine ER), suggest that β3-AR 
agonists possess similar efficacy for the treatment of OAB with an improved tolerability profile 
[Chapple, 2009; Van Kerrebroeck, 2001].  A recent publication demonstrated that patients 
prescribed mirabegron remained on treatment longer and showed greater adherence than those 


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prescribed traditional antimuscarinics, and mirabegron was associated with a favorable safety 
and tolerability profile [Chapple, 2017]. 
Vibegron is a potent, highly selective, orally available β3-AR agonist demonstrating >9,000 fold 
selectivity for activation of 3-AR over 2-AR and 1-AR in cell based in vitro assays.  
Βeta-adrenergic receptors (β-AR) are prototypic G-protein coupled receptors expressed on the 
surface of cells and mediate intracellular signaling via coupling to G proteins and increasing 
levels of intracellular cyclic adenosine monophosphate (cAMP).  β3-ARs are widely distributed 
in humans and are the most prevalent β-AR subtype expressed on human detrusor smooth 
muscle [Takeda, 2000].  In isolated human bladder smooth muscle, activation of β3-AR using 
subtype-selective agonists results in smooth muscle relaxation suggesting a role of β3-AR 
agonists during the filling phase of the micturition cycle [Yamaguchi, 2002; Biers, 2006].  In 
rodent models of bladder overactivity, β3-AR agonists relax bladder smooth muscle and suppress 
non-neurogenic and neurogenic detrusor over activity [Takeda, 2000; Woods, 2001; 
Takeda, 2002; Kaidoh, 2002].  In rhesus monkeys, dose-dependent increases in bladder capacity 
and decreases in micturition pressure were observed with vibegron.  Bladder capacity was further 
increased by vibegron in combination with tolterodine or darifenacin. 
2.3. 
Study Rationale 
The use of vibegron in a large Phase 2b study (Study 008) in patients with OAB has 
demonstrated encouraging safety, tolerability, and efficacy results.  Furthermore, Phase 3 data in 
Japan (Studies 301 and 302) have demonstrated that vibegron is a safe, well tolerated, and 
effective therapy for OAB patients.  Given there are still OAB patients that do not reach their 
treatment goals with currently approved therapies, there remains an unmet need for new OAB 
therapies with a favorable safety, tolerability, and efficacy profile.  This study is designed to 
evaluate the long-term safety, tolerability, and efficacy of vibegron 75 mg administered once 
daily in patients with OAB. 


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3. 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary Safety 
• To evaluate the safety and tolerability 
of vibegron for up to 52 weeks in 
patients with symptoms of overactive 
bladder (OAB) who previously 
completed treatment in study RVT-
901-3003 
• Incidence of any treatment-emergent adverse event by 
system organ class and preferred term 
Secondary and Exploratory 
• To evaluate the efficacy of vibegron 
in patients with symptoms of OAB 
Secondary Endpoints: 
• Change from baseline (CFB) at Week 52 in average 
number of micturitions per 24 hours in all OAB patients 
• CFB at Week 52 in average number of urge urinary 
incontinence (UUI) episodes per 24 hours in OAB Wet 
patients 
• CFB at Week 52 in average number of urgency 
episodes (need to urinate immediately) over 24 hours in 
all OAB patients 
• CFB at Week 52 in average number of total urinary 
incontinence episodes over 24 hours in OAB Wet 
patients 
Exploratory Endpoints: 


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Objectives 
Endpoints 


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4. 
INVESTIGATIONAL PLAN 
4.1. 
Overall Study Design 
This is an international Phase 3, randomized, double-blind, active (tolterodine)-controlled, 
40-week extension study to evaluate the safety, tolerability, and efficacy of vibegron 75 mg 
administered once daily in patients with OAB. 
This study is an extension for patients who have completed the Phase 3, double-blind, 
randomized, 12-week study RVT-901-3003, which evaluated the efficacy, safety, and tolerability 
of vibegron 75 mg administered once daily in patients with OAB.  Approximately 500 men and 
women with overactive bladder who completed 12 weeks in study RVT-901-3003 will be 
permitted to enroll in this extension study. 
During the study, all patients who had been randomized in RVT-901-3003 to receive either 
vibegron 75 mg or tolterodine ER 4 mg will continue their same treatment once daily in a 
blinded fashion for 40 weeks during the extension; patients who had been randomized to the 
placebo group in RVT-901-3003 will be randomized 1:1 to receive blinded study treatment of 
vibegron 75 mg or tolterodine ER 4 mg once daily for 40 weeks during the extension.  Thus, 
through participation in both the RVT-901-3003 study and the RVT-901-3004 (extension) study, 
patients originally randomized to vibegron or tolterodine will receive 52 weeks total of vibegron 
or tolterodine treatment and patients originally randomized to placebo will receive 40 weeks total 
of vibegron or tolterodine treatment. 
Study visits will be named to reflect continuation from the RVT-901-3003 study, with the first 
study visit of this extension study occurring at Week 12.  Following enrollment in this extension 
study, patients will return to the clinic for visits at Week 16, Week 24, Week 36, Week 44 and 
Week 52 (all relative to Day 1 of RVT-901-3003). 
The study consists of a randomized double-blind Treatment Period (40 weeks) and a Safety 
Follow-up Period (4 weeks).  All patients will have a Safety Follow-up Visit approximately 
28 days after the patient’s last dose of study treatment (i.e., at Week 56 for patients who 
complete the Week 52 Visit, or approximately 4 weeks after withdrawal for patients who 
discontinue the study early).  Additionally, unscheduled follow-up visit(s) may be arranged for 
patients with study-related safety concerns as needed. 
Specific procedures to be performed during the study, as well as their prescribed times and 
associated visit windows, are outlined in the Schedule of Activities (Table 1).  Details of study 
procedures are provided in Section 7. 
A schematic of the study design is shown as Figure 1. 


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Figure 1 
RVT-901-3004 Study Schematic 
 


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4.2. 
Treatment Arms and Duration 
Refer to Section 6 for full details of Study Treatments.  Patients will receive one of the following 
blinded treatments during this extension study: 
• Vibegron 75 mg tablet + placebo capsule to match tolterodine ER 4 mg capsule; both 
oral and administered once daily 
• Tolterodine ER 4 mg capsule + placebo tablet to match vibegron 75 mg tablet; both 
oral and administered once daily 
Dosing will begin at the Week 12 Visit (i.e., the baseline visit of the extension study), and once 
daily dosing of the Study Treatment will continue through Study Day 364, the day before the 
Week 52 Visit. 
4.3. 
Number of Participants 
Approximately 500 patients will be enrolled. 
4.4. 
Definition of Study Completion by a Patient 
A patient is considered to have completed the study if she/he completes the Week 52 Visit. 
4.5. 
End of Study Definition 
End of study is defined as the date when the last patient has either completed the study (see 
Section 4.4 for definition of completion), has discontinued from the study, or is lost to follow-up 
(i.e., the patient is unable to be contacted by the Investigator). 


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5. 
STUDY POPULATION 
5.1. 
Eligibility Criteria 
To be eligible for participation in this study, a patient must have completed participation in study 
RVT-901-3003, and continue to meet all the Inclusion Criteria, and none of the Exclusion 
Criteria.   
5.1.1. 
Inclusion Criteria 
1. Has completed participation in study RVT-901-3003. 
2. Willing and able to provide written informed consent. 
3. For females of reproductive potential:  Agrees to remain abstinent or use (or have their 
male partner use) an acceptable method of birth control (as defined in Section 5.2.1) each 
time the patient has intercourse until the Follow-up Visit. 
4. For females of reproductive potential:  Agrees not to donate ova (eggs) until at least 
1 month after the last dose of Study Treatment. 
5. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in 
study RVT-901-3003. 
6. Has completed a minimum of 4 Complete Diary Days for study RVT-901-3003 Week 12. 
7. Is ambulatory and in good general physical and mental health as determined by the 
Investigator. 
8. In the opinion of the Investigator, is able and willing to comply with the requirements of 
the protocol, including completing questionnaires, the Voiding Diary, and Voided 
Volume Diary (will require ability to collect, measure, and record voided volume by 
herself/himself using a graduated urine collection and measurement container [provided 
by the Sponsor, if needed]). 
5.1.2. 
Exclusion Criteria 
1. Was unable to complete participation in study RVT-901-3003 for any reason. 
2. Has a change in history or current evidence of any clinically significant condition, 
therapy, lab abnormality, or other circumstance that might, in the opinion of the 
Investigator, confound the results of the study, interfere with the patient’s ability to 
comply with study procedures, or make participation in the study not in the patient’s best 
interest.  Includes any serious or unstable, clinically relevant change in gastrointestinal, 
renal, hepatic, cardiovascular, lymphatic, or psychiatric, or other medical disorder during 
the RVT-901-3003 study 
3. Has coronary or neurovascular interventions planned during the duration of the study. 
4. Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 
8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on 
most recent available lab results in study RVT-901-3003 or, if in the opinion of the 
Investigator, is uncontrolled. 


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5. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic 
blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per 
minute. 
a. Patients who have systolic blood pressures ≥ 160 mm Hg or < 180 mm Hg are 
excluded, unless deemed by the Investigator and/or Medical Monitor as safe to 
proceed in this study and able to complete the study per protocol; these patients must 
be on stable hypertension medication for at least 90 days.   
b. All patients with signs and symptoms of uncontrolled hypertension, regardless of 
blood pressure measurement, are excluded from the study.  These include, but are not 
limited to neurological symptoms or findings, hematuria, proteinuria, retinopathy, 
unstable angina, acute heart failure. 
6. Has clinically significant ECG abnormality which, in the opinion of the Investigator, 
exposes the patient to risk by participating in the study 
7. Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of 
normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to 
Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent 
available lab results in study RVT-901-3003. 
8. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most 
recent available lab results in study RVT-901-3003. 
9. Use of any prohibited medications as detailed in Section 7.7.3. 
10. Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the 
study that in the opinion of the investigator is assessed to be clinically significant. 
11. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse 
experience associated with any of the active or inactive components of the vibegron 
formulation or tolterodine formulation. 
12. Is currently participating or has participated in a study with an investigational compound 
or device within 28 days of signing informed consent, not including participation in study 
RVT-901-3003. 
13. Has a history of significant drug or alcohol abuse/dependence within a year of informed 
consent, as assessed by the investigator. 
14. Has a varying sleep schedule anticipated during times when the voiding diaries are to be 
completed. 


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5.2. 
On-Study Restrictions 
5.2.1. 
Contraception 
Female Patients 
In this study, female patients must agree to use (or have their male partner use) a highly effective 
contraception, unless any of the following apply: 
• has reached natural menopause, defined as at least 12 months of spontaneous 
amenorrhea without an alternative medical cause; 
• is permanently sterile, following hysterectomy, bilateral salpingectomy, or bilateral 
oophorectomy. 
The highly effective methods of contraception include the following: 
• combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation, which may be oral intravaginal or transdermal 
• progestogen-only hormonal contraception associated with inhibition of ovulation, 
which may be oral, injectable, or implantable 
• intrauterine device (IUD)  
• intrauterine hormone-releasing system (IUS) 
• bilateral tubal occlusion (including ligation and blockage methods such as Essure™ at 
least 6 months prior to the initial Screening Visit [patients with Essure must have 
prior confirmation of tubal occlusion by hysterosalpingogram]) 
• sexual partner(s) who was vasectomized at least 6 months prior to the Screening Visit 
• sexual abstinence from heterosexual intercourse, as a preferred lifestyle; periodic 
abstinence is not acceptable 
Patients will be provided with information on acceptable methods of contraception as part of the 
informed consent process and will confirm when they sign a consent form they understand the 
requirements for avoidance of pregnancy during the course of the study. 
These methods of contraception are only effective when used consistently, correctly, and in 
accordance with the product label.  The Investigator is responsible for ensuring that patients 
understand how to properly use these methods of contraception. 
5.2.2. 
Meals and Dietary Restrictions 
Patients may consume a normal, regular diet and take their Study Treatment daily without regard 
to food or other medications. 
Patients do not need to fast prior to laboratory draws. 


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5.3. 
Screen Failure 
For patients who provide informed consent and subsequently do not meet eligibility criteria or 
withdraw consent prior to randomization in RVT-901-3004, study site personnel should 
document the screen failure in the patients' source documents.  The documentation should 
include demographics and medical history, the reason for screen failure, the eligibility criteria 
reviewed, procedures performed, etc. 
The screen failure should be reported promptly to interactive voice or web response system 
(IxRS). 
5.4. 
Interruption of Study Treatment 
5.4.1. 
Temporary Interruption 
The medical monitor should be contacted for Study Treatment interruption of > 7 days in 
duration.  Study treatment may be temporarily interrupted for up to 21 consecutive days if 
required for adverse event management, as described in Section 6.6. 
5.4.2. 
Rechallenge 
See Section 6.6. 
5.5. 
Withdrawal from the Study 
Patients may withdraw consent at any time for any reason or be withdrawn from the study at the 
discretion of the Investigator should any untoward effect occur.  Every effort should be made to 
establish and document the possible reasons for withdrawal.  A patient may be withdrawn by the 
Investigator or the Sponsor if enrollment into the study is inappropriate, the study plan is 
violated, or for administrative and/or other safety reasons.  The patient may be discontinued from 
further study participation after discussion between the Investigator and the Sponsor clinical 
monitor (or designee) if the patient requires therapy with any excluded medication.  Medications 
that may cause a patient to be discontinued have been described in Section 7.7.3. 
A patient must be discontinued from the study for any of the following reasons: 
• The patient or legal representative (such as a legal guardian) withdraws consent. 
• Study treatment administration is interrupted for more than 21 consecutive days. 
• The patient has a medical condition or personal circumstance which, in the opinion of 
the Investigator and/or Sponsor, places the patient at unnecessary risk through 
continued participation in the study or does not allow the patient to adhere to the 
requirements of the protocol. 
• The patient has a confirmed positive serum pregnancy test. 
• The patient is unable to complete the study procedures successfully, including 
completion of the Patient Voiding Diary. 


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When a patient withdraws from the study prior to study completion, all applicable activities 
scheduled for the Week 52 Visit should be performed at the time of withdrawal.  Any adverse 
events that are present at the time of withdrawal should be followed in accordance with the 
safety requirements outlined in Section 8. 
Once a patient is withdrawn, he/she shall not be allowed to enroll again. 
5.6. 
Lost to Follow Up 
Should a patient fail to attend a required study visit, the site should attempt to contact the patient 
and re-schedule the missed visit as soon as possible.  The site should also counsel the patient on 
the importance of maintaining the assigned visit schedule and ascertain whether or not the patient 
wishes to and/or should continue in the study based on previous non-compliance.  In cases where 
the patient does not return for the rescheduled visit or cannot be reached to reschedule the missed 
visit, the site should make every effort to regain contact with the patient so that they can 
appropriately be withdrawn from the study with a primary reason of “Lost to Follow-up”.  
Including at least three documented attempts to contact the patient (i.e., phone, email, or certified 
letter).  Efforts to establish the possible reason for discontinuation should be documented. 
5.7. 
Early Study Termination 
The study may be terminated early if the extent (incidence and/or severity) of emerging 
effects/clinical endpoints is such that the risk/benefit ratio to the study population as a whole is 
unacceptable.  In addition, further recruitment in the study overall or at a particular study site 
may be stopped due to insufficient compliance with the protocol, Good Clinical Practice (GCP) 
and/or other applicable regulatory requirements, procedure-related problems or the number of 
discontinuations for administrative reasons is too high. 


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6. 
STUDY TREATMENT 
6.1. 
Study Treatments Description 
Study Treatment is defined as vibegron or tolterodine.  All Study Treatments will be provided by 
the Sponsor. 
Each Study Treatment is described in Table 2. 
Table 2 
RVT-901-3004 Study Treatments 
Study Treatment 
Dose 
Frequency; Route of 
Administration; 
Description 
Use 
Vibegron 
75 mg 
Once daily; oral; tablet 
Experimental 
Tolterodine ER 
4 mg 
Once daily; oral; capsule 
Active control 
Placebo to match vibegron 75 mg 
NA 
Once daily; oral; tablet 
Blinding 
Placebo to match tolterodine ER 4 mg NA 
Once daily; oral; capsule 
Blinding 
 
6.2. 
Administration of Study Treatments 
Throughout the study, all Study Treatments will be taken by mouth once daily in the morning 
with 8 ounces of water and should be swallowed whole.  Study Treatment may be taken without 
regard to meals. 
All doses of Study Treatment will be taken by the patient at home. 
If a patient forgets to take Study Treatment in the morning, the missed dose should be taken as 
soon as possible on the same calendar day.  However, if a dose is missed for an entire calendar 
day, the missed dose should NOT be taken on the following calendar day.  This will be recorded 
as a missed dose. 
6.3. 
Study Treatment Assignment 
Randomization will occur centrally using an IxRS.  Enrollment in this extension study will be 
capped at approximately 500 patients.  There are two treatment arms in this study: 
• Vibegron 75 mg + placebo to match tolterodine ER 4 mg 
• Tolterodine ER 4 mg + placebo to match vibegron 75 mg 
Patients will be assigned to double-blind Study Treatment as follows: 
• All patients randomized to vibegron 75 mg in study RVT-901-3003 will be assigned 
to take vibegron 75 mg during the 40-week extension study. 
• All patients randomized to placebo in study RVT-901-3003 will be randomized 1:1 
and assigned to take vibegron 75 mg or tolterodine ER 4 mg during the 40-week 
extension study. 


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• All patients randomized to tolterodine ER 4 mg in study RVT-901-3003 will be 
assigned to take tolterodine ER 4 mg during the 40-week extension study. 
6.4. 
Blinding 
A double-blind/masking technique will be used:  vibegron and its matching placebo and 
tolterodine ER and its matching placebo will be packaged identically so that treatment 
blind/masking is maintained.  The patient and the Investigator involved in the treatment or 
clinical evaluation of the patients are unaware of the treatment group assignments.  Specific 
Sponsor personnel and delegate(s) will be partially unblinded once RVT-901-3003 reaches 
database lock.  However, Sponsor personnel and delegates involved in patient-level decisions 
will remain blinded.  Therefore, the blinding strategy for the RVT-901-3004 study will be 
double-blind, Sponsor open (partially unblinded). 
At the end of the study (including the 28-day Follow-up Period), the official, final database will 
be frozen and unblinded after medical/scientific review has been performed, and data have been 
declared final and complete.  The Sponsor will be granted access to the unblinded database in 
order to analyze the data.  A clinical study report will be prepared after all patients complete the 
study. 
6.4.1. 
Unblinding 
All efforts should be made to contact the Medical Monitor immediately if the need for emergent 
unblinding of treatment assignment is desired.  In consultation with the Medical Monitor, IxRS 
should be used for emergency unblinding treatment assignment in the event that this is required 
for patient safety. 
In the event that unblinding has occurred, the circumstances around the unblinding (e.g., date and 
reason) must be documented promptly, and the Sponsor notified as soon as possible.  Only the 
Principal Investigator or delegate and the respective patient’s code should be unblinded.  Site 
personnel and Sponsor personnel directly associated with the conduct of the study should not be 
unblinded. 
6.5. 
Dose Modification 
No dose modifications are allowed. 
6.6. 
Treatment Discontinuation and Rechallenge 
Refer to Section 8.6.1 and Section 8.6.2, respectively, for information regarding temporary 
interruption or permanent discontinuation of Study Treatment in association with liver test 
abnormalities. 
Patients who experience a grade 3 or greater toxicity that is considered related to Study 
Treatment should have their treatment discontinued permanently. 
Patients who experience a grade 3 or 4 adverse event that is not related to Study Treatment may 
have their Study Treatment interrupted for a period of up to 21 consecutive days if the 
Investigator believes it is in the best interest of the patient.  (Refer to Table 5 for Criteria for 


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Determining the Grade/Severity of Adverse Event Terms).  Prior to restarting Study Treatment, 
the adverse event must have improved to grade 0, 1, or 2. 
If the adverse event that is not related to Study Treatment remains grade 3 or grade 4 after 
treatment interruption or the Investigator believes it is in the best interest of the patient, Study 
Treatment should be discontinued permanently. 
6.7. 
Packaging and Labeling 
Clinical supplies will be affixed with a clinical label in accordance with regulatory requirements.  
Patients will receive a double-blind supply of Study Treatment bottles at each study visit during 
the Treatment Period. 
6.8. 
Preparation/Handling/Storage/Accountability 
Clinical supplies must be stored in a secure, limited-access location under the storage conditions 
specified on the label. 
Receipt and dispensing of Study Treatment must be recorded by an authorized person at the 
study site. 
Clinical supplies may not be used for any purpose other than that stated in the protocol. 
The Investigator is responsible for keeping accurate records of the clinical supplies received 
from the Sponsor or designee, the amount dispensed to and returned by the patients, and the 
amount remaining at the conclusion of the study.  These records will be monitored throughout 
the study. 
For all sites, the local country Sponsor personnel or designee will provide appropriate 
documentation that must be completed for drug accountability and return. 
6.9. 
Study Treatment Compliance 
If a patient is persistently noncompliant with the Study Treatment, it may be appropriate to 
withdraw the patient from the study.  Interruptions from the protocol specified treatment plan for 
compliance (≤ 75% or >125%) require consultation between the Investigator and the Sponsor 
and written documentation of the collaborative decision on patient management. 
6.10. 
Study Treatment Overdose 
Refer to Section 8.3.3 for Overdose Management.  An overdose is defined as a known deliberate 
or accidental administration of Study Treatment, to or by a study patient, at a dose above that 
assigned to that individual patient according to the study protocol. 
For this study, any dose of vibegron or placebo > 2 tablets and any dose of tolterodine or placebo 
> 2 capsules within a 24-hour window (i.e., > 2 tablets and/or > 2 capsules of blinded Study 
Treatment within a 24-hour window) is an overdose.  There is no known antidote for an 
overdose. 


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6.11. 
Treatment after the End of the Study 
Patients will not receive any additional treatment with the Study Treatment from the Sponsor 
after completion of the study because the indication being studied is not life-threatening or 
seriously debilitating and/or other treatment options are available.  The Investigator is 
responsible for ensuring that consideration has been given to the post-study care of the patient’s 
medical condition. 


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7. 
STUDY ASSESSMENTS AND PROCEDURES 
The Schedule of Activities (Section 1.1) summarizes the study assessments/procedures to be 
performed at each visit.  Individual assessments and procedures are described below. 
It may be necessary to perform these procedures at unscheduled time points if deemed clinically 
necessary by the Investigator.  Furthermore, additional evaluations/testing may be deemed 
necessary by the Investigator and/or the Sponsor for reasons related to patient safety.  In some 
cases, such evaluation/testing may be potentially sensitive in nature, and thus local regulations 
may require that additional informed consent be obtained from the patient.  In these cases, such 
evaluations/testing will be performed in accordance with those regulations. 
7.1. 
Order of Assessments 
Vital signs, followed by PRO questionnaires, will be the first procedures performed at visits that 
include PRO administration.  Blood draws should be performed after PRO administration.  A 
urine pregnancy test (with a negative result) must be done prior to randomization. 
7.2. 
Scheduling Visits 
To the extent possible, all visits should occur at the same time across the study between the hours 
of 8 am and 12 pm.  At the end of each visit, the next visit should be scheduled/confirmed.  
Every effort should be made to adhere to the visit scheduling window as described in the 
Schedule of Activities (Section 1.1) to ensure the patient has an adequate amount of Study 
Treatment to comply with protocol dosing instructions.  Patients will be reminded to complete 
the Patient Voiding Diary and Urine Volume Diary within the 7 days prior to their next visit. 
7.3. 
Unscheduled Visits 
Unscheduled Visits may be performed at any time during the study whenever necessary to assess 
for or follow-up on adverse events, at the patient’s request, or as deemed necessary by the 
Investigator.  The date and reason for the Unscheduled Visit should be recorded in the source 
documentation.  The specific procedures performed at these visits will be determined by the 
Investigator, as clinically indicated.  The recommended minimum procedures are indicated in the 
Schedule of Activities (Section 1.1). 
7.4. 
Assignment of Patient Number 
Patients will retain the unique patient number that was assigned in study RVT-901-3003. 
7.5. 
Informed Consent 
Documented consent must be obtained from each potential patient prior to participating in study 
procedures.  Consent must be documented by the patient’s dated signature on a consent form 
along with the dated signature of the person conducting the consent discussion. 
A copy of the signed and dated consent form should be given to the patient before participation 
in the study. 
The initial informed consent form, any subsequent revised written informed consent form, and 
any written information provided to the patient must receive institutional review board 


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(IRB)/research ethics board (REB)/institutional ethics committee (IEC) approval/favorable 
opinion in advance of use.  The patient should be informed in a timely manner if new 
information becomes available that may be relevant to the patient’s willingness to continue 
participation in the study.  The communication of this information will be provided and 
documented via a revised consent form or addendum to the original consent form that captures 
the patient’s dated signature. 
Specifics about a study and the study population will be added to the consent form template at 
the protocol level. 
The informed consent will adhere to IRB/REB/IEC requirements, applicable laws and 
regulations and Sponsor requirements. 
7.6. 
Inclusion/Exclusion Criteria 
Prior to randomization in RVT-901-3004, all inclusion and exclusion criteria will be reviewed by 
the Investigator or qualified designee to ensure that the patient qualifies for the study. 
All inclusion criteria must be met and none of the exclusion criteria may apply.  No eligibility 
waivers will be granted. 
Patients found ineligible during review of inclusion/exclusion will not proceed through the 
randomization process. 
Compliance with self-administration of Study Treatment in study RVT-901-3003 will be 
calculated based on the tablet/capsule counts recorded in the IxRS of the Run-In and Treatment 
phase in study RVT-901-3003 (Visits #2 through Visit # 6).   
Laboratory results from the Week 4 Visit of RVT-901-3003 study will be used as a basis to 
confirm eligibility for glucose, AST, ALT, and eGFR.  Urine pregnancy test, Urine dipstick 
results, ECG and average blood pressure measure will be confirmed prior to randomization.  
Concomitant medications will be reviewed at to ensure required stability. 
7.7. 
Prior and Concomitant Medications 
7.7.1. 
Prior Medications 
The Investigator or qualified designee will review prior medication use, including all prior 
medications used for the treatment of OAB, and assess for any medically relevant changes.  
Consult the medical monitor if there is any uncertainty regarding patient use of a particular drug 
or drug class. 
7.7.2. 
Concomitant Medications 
Concomitant medications will be reviewed and recorded at each study visit.  Patients will be 
informed at the study start regarding permissible medications during the study.  The Investigator 
or qualified designee will record all medications, if any, taken by the patient during the study.  
This will include initiation of new medications, or changes to existing/ongoing medications. 
Upon entry into the study, patients will be instructed to report the possible need for any 
prescription or nonprescription medications immediately (and before use) to the Investigator. 


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7.7.3. 
Prohibited Medications and Non-Drug Therapies 
Table 3 provides a listing of specific restrictions for concomitant therapy use during the study, 
with any necessary washout periods described.  This table provides examples of prohibited drug 
categories; however, it is not a comprehensive list of all restricted medications. 
Use of other concomitant therapies that are listed in Section 7.7.5 are also prohibited if the 
patient’s dose has changed during the RVT-901-3003 study or if the patient plans to initiate or 
change any of these therapies during the study (as deemed clinical relevant in the opinion of the 
investigator). 
If there is a clinical indication for any therapy that is specifically prohibited during the study, 
discontinuation from Study Treatment may be required.  The Investigator should discuss any 
questions regarding this with the medical monitor.  The final decision on any supportive therapy 
rests with the Investigator and/or the patient's primary physician.  However, the decision to 
continue the patient on Study Treatment requires the mutual agreement of the Investigator, the 
Sponsor, and the patient. 
Consult the medical monitor if there is any uncertainty regarding patient use of a particular drug 
or drug class. 
Table 3 
Listing of Prohibited Medications 
Class 
Examples 
Washout Period/Comments 
Anticholinergics 
darifenacin, fesoterodine, hyoscyamine, 
oxybutynin, propantheline, solifenacin, 
tolterodine, and trospium 
Patient must remain off this 
therapy during the study 
Smooth muscle relaxants 
flavoxate, dicyclomine, propiverine 
Patient must remain off this 
therapy during the study 
Beta-2 adrenergic agonists used 
for the treatment of stress 
urinary incontinence 
clenbuterol 
Patient must remain off this 
therapy during the study 
Systemic beta-2 adrenergic 
agonist 
terbutaline 
Patient must remain off this 
therapy during the study 
Synthetic antidiuretic hormones desmopressin 
Patient must remain off this 
therapy during the study 
Beta-3 adrenergic agonists 
mirabegron 
Patient must remain off this 
therapy during the study 
Medications with a narrow 
therapeutic indexa 
Warfarin, digoxin, lithium, phenytoin, 
theophylline 
Patient must remain off the 
example medications during 
the study 
Intradetrusor botulinum toxins 
intradetrusor injection of botulinum 
toxin 
Patient must not receive this 
therapy during the study 
a Only the listed example medications (warfarin, digoxin, lithium, phenytoin, and theophylline) are prohibited; other 
medications with a narrow therapeutic index (e.g., levothyroxine sodium) are not prohibited. 
 


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7.7.4. 
Permitted Medications and Non-Drug Therapies 
Consult the medical monitor if there is any uncertainty regarding the clinical relevance of patient 
use of a particular drug or drug class. 
7.7.5. 
Requirements for Use of Stable Therapies 
Patients who are receiving any of the therapies from the list below must have been on a stable 
dose to be eligible to enroll in the study.  Additionally, patients who plan to initiate or change 
any of the following therapies during the study are not eligible to enroll in the study (when the 
change is deemed clinically relevant by the investigator): 
• Tricyclic antidepressants or combinations, including, but not limited to, amitriptyline, 
imipramine, and doxepin. 
• Alpha-1-antagonists, unless used for BPH treatment, in which case, stable dosing for 
3 months is required. 
• Serotonin and/or norepinephrine reuptake inhibitors, including, but not limited to, 
fluoxetine, paroxetine, and duloxetine. 
• Alpha-adrenergic agonists, including nonspecific sympathomimetic amines, such as, 
but not limited to, ephedrine, pseudoephedrine, and phenylephrine. 
• Diuretic therapy, including, but not limited to, furosemide and hydrochlorothiazide. 
• Inhaled anticholinergic, including, but not limited to, tiotropium bromide and 
ipratropium bromide. 
• Regular use of phosphodiesterase type 5 (PDE 5) inhibitors, including, but not limited 
to, tadalafil, sildenafil, and vardenafil. 
Note:  Occasional use of PDE 5 inhibitors (e.g., for the treatment of erectile dysfunction) 
is allowed throughout the study. 
Male patients with mild to moderate BPH without evidence of bladder obstruction as determined 
by the Investigator may be included as long as they have been taking a medication for the 
treatment of BPH for at a least 1-year prior to Baseline, with no change in dose of herbal 
medications, alpha antagonist medications, or other symptomatic treatments or medications.  To 
be eligible for the study, these BPH medication/s must have been stable during the RVT-901-
3003 study. 
Patients with a history of hypertension must be on a stable blood pressure treatment regimen and 
must be deemed by the Investigator and/or Medical Monitor as safe to proceed in this study and 
able to complete the study per protocol. 
Patients with a history of cerebral vascular accident, transient ischemic attack, unstable angina, 
myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or 
percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular 
interventions (e.g., carotid artery stenting) should be on stable medical therapy.  To be eligible 
for the study, these medication/s must have been stable during the RVT-901-3003 study and 
anticipated to be stable throughout the extension study, unless approved by the medical monitor. 


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7.8. 
Patient Voiding Diary 
The Patient Voiding Diary is used by participants (via the eDiary or paper Diary) to record the 
frequency of daily OAB symptoms including all micturitions, urgency, incontinence, and main 
reason for incontinence by selecting the respective box for each symptom occurring during the 
course of a given day and night. 
The Patient Voiding Diary should be completed by the patient on all of the 7 days prior to the 
Weeks 16, 24, 44, and 52 Visits. 
A “Diary Day” is defined as the time between when the patient gets up for the day each morning 
(i.e., the time the patient got up for the day yesterday to the time the patient got up for the day 
today; approximately a 24-hour period). 
A “Complete Diary Day” is defined as a Diary Day for which the patient indicates that they 
have recorded all urinations and any leakages that occurred during that Diary Day.  More 
specifically, a “Complete Diary Day” is defined as a Diary Day that includes input of micturition 
data by patients on the voiding diary, and unless a patient indicated “No” to the questions of 
“Did you record each time you urinated or leaked during this Diary Day”, the Diary Day is 
considered complete. 
7.8.1. 
Patient Voiding Diary Training/Re-Training 
All Visits 
The site staff should inquire whether patients had any difficulties with the diary and address any 
questions patients may have.   
Instructions for proper completion of the Patient Voiding Diary should be re-reviewed, and, if 
available, patients may view an instructional video to reinforce their understanding of Patient 
Voiding Diary instructions. 
Patients will be trained to enter data immediately following each event (in real time) and to input 
data from any “missed” events as soon as they are able.  They will review and confirm that data 
from all events occurring within the preceding Diary Day (approximately 24 hours) have been 
entered at a consistent time each morning (e.g., upon getting up for the day). 
7.9. 
Urine Volume Diary 
Urine volume data are collected separately by patients using the Urine Volume component of the 
eDiary, or the paper Urine Volume Chart.  The Urine Volume Chart is a tool routinely used in 
clinical practice and clinical investigation to assess voiding functions over a 24-hour period and 
is regarded as a useful instrument in the investigation of patients with voiding symptoms.  Urine 
volume may be collected during any one (1) of the 7 Diary Days prior to the visit, and it should 
be recorded for ~24-hours starting from the time the patient gets up for the day and continues 
until the time the patient gets up for the day on the next day.   
Patients will be asked to complete the Urine Volume Diary to record their urine volume passed 
during that day.  The Urine Volume collection and Urine Volume Diary completion should be 
performed by the patient on a day that they choose for one (1) complete day of the 7 days prior to 
the Weeks 16, 24, 44, and 52 Visits.  The definition of a Diary Day and data entry instructions 


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will be the same as for the Patient Voiding Diary (i.e., the data should be recorded in real time, 
morning to morning). 
7.9.1. 
Urine Volume Collection Training/Re-Training 
At each subsequent visit the site staff should confirm the patient’s understanding and ability to 
measure a volume of water as practice. 
Patients should be instructed that on the days the paper Urine Volume Chart Diary is completed: 
• Every micturition recorded on the Patient Voiding Diary must have a corresponding 
entry recorded on the Urine Volume Chart (this is automatically done on the eDiary). 
• Every entry recorded on the Urine Volume Chart must have a corresponding 
micturition recorded on the Patient Voiding Diary (this is automatically done on the 
eDiary). 
Site staff should reinstruct the patient on Urine Volume collection procedures as needed.  
Instructions for proper completion of the Urine Volume Chart should be re-reviewed, and, if 
available, patients may view an instructional video to reinforce their understanding of the Urine 
Volume Chart and collection instructions. 
7.9.2. 
Dispense Urine Collection and Measurement Supplies 
The urine collection and measurement container (if needed) are reusable and should be rinsed by 
patients and reused for the days that they will be collecting their urine volume throughout the 
study.  Patients should be reminded to keep the urine collection container with them during the 
period of time when urine volume is being collected. 
7.10. 
Reminders for Diary Collection 
The site will phone the patient on approximately the first day and the third (or next business 
days) of the 7 Diary collection days.  Patients will be reminded to enter data immediately 
following each micturition (in real time); they will also be asked to input data from any “missed” 
events and confirm that data from all micturitions occurring within the preceding 24 hours have 
been entered at a consistent time each morning (e.g., upon getting up for the day).  Patients may 
consent to receive additional reminders via SMS text to their personal mobile phone.  In addition 
to visit reminders, these diary completion reminders will be sent the day before each diary 
collection period begins (to remind patients to start diary completion) and two days prior to the 
end of each diary collect window (to ensure urine volume collection has been completed prior to 
the visit).   
7.11. 
Electronic Diary 
The Electronic Diary (eDiary) for this study includes both the Patient Voiding Diary and the 
Urine Volume Diary and will be implemented via an eDiary device (provisioned smartphone).  
Paper diaries will be provided to all patients to be used when necessary.  When a paper diary is 
used, it should be collected at each visit.   


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7.11.1. 
eDiary Device Set-Up and Training 
Device Setup/Function Check 
The eDiary device will be set-up by the site at the Week 12 Visit and dispensed to the Patient.  
At each subsequent visit, site personnel will check that the device is functioning correctly.  
Instructions on how to perform the set-up task will be provided by the Sponsor. 
7.11.2. 
Device Training/Re-Training 
The site staff should inquire whether patients had any difficulties with the diary and address any 
questions patients may have. 
 
Instructions for proper completion of the eDiary should be re-reviewed, and, if available, patients 
may be asked to view an instructional video to reinforce their understanding of Patient Voiding 
Diary instructions. 
 
Patients will be asked to enter data immediately following each micturition (in real time); they 
will also be asked to input data from any “missed” micturition and confirm that data from all 
micturitions occurring within the preceding 24 hours have been entered at a consistent time each 
morning (e.g., upon getting up for the day). 
 
7.12. 
Patient-Reported Outcomes 
Patients will complete paper questionnaires at the site at the start of each required study visit to 
assess patient-perceived symptom relief, symptom bother, and health-related quality of life at the 
study visits.  These include the following questionnaires: 
• Global Impression Items include Patient Global Impression of Severity (PGI-Severity), 
Patient Global Impression of Control (PGI-Control), Patient Global Impression of 
Frequency (PGI-Frequency), Patient Global Impression of Leakage (PGI-Leakage), and 
Patient Global Impression of Change (PGI-Change).   
• Overactive Bladder Questionnaire (OAB-q long form [OAB-q LF], 1-week recall) is a 
multi-item questionnaire that was developed to assess symptom bother and the impact of 
overactive bladder on health-related quality of life.  The instrument was developed and 
validated in both continent and incontinent OAB patients, including both men and 
women. 
• Work Productivity and Activity Impairment Questionnaire-Urinary Symptoms (WPAI-
US), version 2.0, is a 6-item questionnaire that assesses health-related work productivity 
loss due to urinary symptoms with a 1-week recall period.   
• The EQ-5D health questionnaire is a standardized instrument for use as a measure of 
health outcome [Rabin, 2014].  It is applicable to a wide range of health conditions and 
treatments; it provides a simple descriptive profile and a single index value for health 
status. 


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The Investigator should not provide any additional information to patients prior to completing 
the questionnaires which might influence responses. 
7.13. 
Post-Void Residual Volume 
The risk of acute urinary retention or morbidities related to an increase in Post-Void Residual 
(PVR) is a concern with antimuscarinic therapy that promotes smooth muscle relaxation by 
inhibiting acetylcholine-induced smooth muscle contraction.  If, during contraction, the bladder 
cannot generate enough pressure to overcome the outlet resistance in the urethra, either because 
of poor detrusor contractility or profound obstruction (most commonly from BPH), acute urinary 
retention or incomplete emptying of the bladder may result. 
The volume of urine that remains in the bladder after voiding (PVR) is an objective measurement 
that may serve as a proxy for impaired ability to void.  The physician should assess patients with 
an increase in PVR for an adverse event. 
PVR will be performed via ultrasound at the visits indicated in the Schedule of Activities in 
Section 1.1.  All efforts will be made to ensure the same device and operator are used for all 
PVR measurements for individual patients. 
7.14. 
Physical Examination 
Focused physical examinations will include examination of heart, lungs, abdomen as well as 
any other organ system in which a previous abnormality was noted at Baseline (in study 
RVT-901-3003) or relates to a patient complaint of an adverse event. 
7.15. 
Electrocardiogram 
A single twelve-lead ECG will be performed at the Week 12 Visit and may be performed, 
as clinically indicated, at an Unscheduled Visit. 
All ECGs should be performed after 10 minutes of rest in a semi-recumbent position. 
7.16. 
Vital Signs 
Vital signs including blood pressure, heart rate, respiration rate, and temperature (oral or 
tympanic) will be obtained at all visits after patients have rested quietly in a sitting position for 
5 minutes. 
Three blood pressure measurements will be taken in a sitting position and performed on the same 
arm and by the same site staff, if possible, for each patient throughout the study.  The following 
instructions should be followed: 
• Sitting systolic and diastolic blood pressures will be determined by averaging 3 replicate 
measurements obtained 1 to 2 minutes apart.  The average of the 3 replicate blood 
pressure measurements will be used for eligibility and safety assessments (not an 
individual value).   
The same method for assessing temperature should be used at all visits for a particular patient. 
Body weight will be measured with patients in street clothing with jacket/coat and shoes 
removed. 


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7.17. 
Adverse Events 
Spontaneously reported adverse events will be recorded at each visit.  The Investigator or site 
staff is responsible for detecting, documenting, and reporting events that meet the definition of 
an adverse event or serious adverse event.  See Section 8 for details on adverse event definitions 
and reporting. 
7.18. 
Clinical Laboratory Assessments 
Details regarding specific laboratory procedures/assessments to be performed in this study are 
provided below.  The total amount of blood/tissue to be drawn/collected over the course of the 
study (from pre-study to post-study visits), including approximate blood/tissue volumes 
drawn/collected by visit and by sample type per patient can be found in Appendix 3. 
Please refer to the Schedule of Activities (Section 1.1) for specific laboratory tests performed at 
each study visit. 
7.18.1. 
Chemistry, Hematology, and Urinalysis (Laboratory Safety Evaluations) 
Laboratory tests for chemistry, hematology, and urinalysis are specified in Table 4.  Patients do 
not need to fast prior to laboratory safety tests. 
Analysis of hematology and chemistry will be performed by the central laboratory chosen by the 
Sponsor.  A urine dipstick and urine pregnancy test (for women of childbearing potential) will be 
performed at the site (supplied by the central laboratory).  A sample for urinalysis (including 
microscopy [RBCs, WBCs, epithelial cells, and bacteria]) AND urine culture will be sent to the 
central laboratory only if the urine dipstick tests positive for the presence of leukocytes, nitrites, 
or blood cells.  If a patient reports symptoms that are suggestive of a urinary tract infection at 
any visit, a urine dipstick should be performed and a sample sent for urinalysis and culture, as 
needed. 
If all laboratory values are within the normal reference range, the patient may continue to be 
evaluated for study entry.  If one or more values fall outside the normal range, the Investigator 
may either exclude the patient from the study or investigate further to determine clinical 
relevance.  Please refer to Appendix 2 for an algorithm for assessing out-of-range laboratory 
values. 


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Table 4 
Laboratory Tests 
Hematology 
Chemistry 
Urinalysisa 
Other 
Hematocrit 
Albumin 
Blood 
Serum β-human chorionic 
gonadotropin (β-hCG)b  
Hemoglobin 
Alkaline phosphatase 
Glucose 
 
Platelet count 
Alanine aminotransferase 
(ALT) 
Protein 
 
WBC (total and 
differential) 
Aspartate aminotransferase 
(AST) 
Specific gravity 
 
RBC 
Bicarbonate 
Microscopic exam, 
(RBCs, WBCs, 
epithelial cells, and 
bacteria) 
 
 
Calcium 
pH 
 
 
Chloride 
Color 
 
 
Creatininec 
Urine pregnancy test 
(β-hCG) 
 
 
Glucose (fasting or non-
fasting) 
 
 
 
Potassium 
 
 
 
Sodium 
 
 
 
Total Bilirubin 
 
 
 
Direct Bilirubind 
 
 
 
Blood Urea Nitrogen 
 
 
 
Total Cholesterol 
 
 
a. A sample for urinalysis and urine culture will be sent to the central laboratory only if the urine dipstick 
performed at the site tests positive for the presence of leukocytes, nitrites, or blood cells. 
b. Urine β-hCG will be tested for women of childbearing potential only.  If urine β-hCG is positive, a 
serum β-hCG must be performed. 
c. eGFR will be calculated and reported by the central lab. 
d. If total bilirubin is elevated above the upper limit of normal. 
 


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7.18.2. 
Urine β-hCG 
Women of childbearing potential only must have a urine β-hCG pregnancy test at each study 
visit indicated on the Schedule of Activities (Section 1.1).  A urine pregnancy test (supplied by 
the central laboratory) will be performed at the site.  A positive urine β-hCG test must be 
followed up with a serum β-hCG pregnancy test.  A positive pregnancy test prior to 
randomization requires exclusion.  A positive urine β-hCG test after randomization requires 
immediate interruption of Study Treatment until a serum β-hCG is performed and found to be 
negative.  Patient must be discontinued from the study and followed if pregnancy is confirmed 
by a positive serum β-hCG. 
7.19. 
IxRS Randomization to Study Treatment 
Assignment of patients to double-blind Study Treatment in this study is described in Section 4.1 
and Section 6.3.  The Study Treatment assignments will be managed/recorded via the IxRS. 
7.20. 
Dispense Double-Blind Study Treatment 
At the Week 12, 16, 24, 36 and 44 Visits, double-blind Study Treatment will be dispensed to 
patients, as described in Section 6, and according to their randomized treatment assigned per 
IxRS. 
7.21. 
Study Treatment Return/Accountability Review 
Patients should bring all unused study drug to each study visit.  A complete tablet/capsule count 
will be performed, and results will be recorded as the primary source of patient Study Treatment 
compliance.  Tablet/capsule counts will also be recorded in the IxRS.  All patients should be 
reinstructed regarding dosing compliance during study visits.  The authorized study personnel 
conducting the re-education must document the process in the patient’s source records. 
7.22. 
Follow-up Visit 
The Follow-up Visit should be performed 28 days after the patient’s last dose of Study 
Treatment to collect information about any serious adverse events that occurred during this 
period.  For a patient who discontinues Study Treatment early, the Follow-up Visit should occur 
28 days after the last dose of Study Treatment.  However, if the discontinuation visit occurs 
≥ 28 days after the patient’s last dose of Study Treatment, that visit will serve as the Follow-up 
Visit.  Safety labs may be collected for the evaluation of adverse experiences during 
discontinuation at the discretion of the Investigator. 


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8. 
SAFETY CONSIDERATIONS 
Study assessments of safety include adverse events, physical examinations, vital signs (and 
weight), and clinical laboratory tests. 
8.1. 
Definition of an Adverse Event 
An adverse event is any untoward medical occurrence in a patient or clinical investigation 
patient, temporally associated with the use of a medicinal product, whether or not considered 
related to the medicinal product. 
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use 
of a medicinal product or protocol-specified procedure, whether or not considered related to the 
medicinal product or protocol-specified procedure.  Any worsening (i.e., any clinically 
significant adverse change in frequency and/or intensity) of a preexisting condition that is 
temporally associated with the use of the Sponsor’s product, is also an adverse event. 
Events meeting the definition of an adverse event include: 
• A worsening, excluding minor fluctuations, in the nature, severity, frequency, or duration 
of a pre-existing condition; 
• A new condition detected or diagnosed after investigational product administration even 
though it may have been present prior to the start of the study; 
• Injury or accidents:  If a medical condition is known to have caused the injury or 
accident, the medical condition and the accident should be reported as 2 separate medical 
events (e.g., for a fall secondary to dizziness, both “dizziness” and “fall” should be 
recorded separately);  
• An investigational abnormality (e.g., laboratory parameter, vital sign, ECG) only if the 
abnormality is considered clinically significant by the Investigator based on at least one 
of the following criteria: 
− Induces clinical signs or symptoms; 
− Requires active intervention;  
− Requires interruption or discontinuation of Study Treatment.   
• Signs, symptoms, or the clinical sequelae of a suspected interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either 
investigational product or a concomitant medication. 
• Events that do not meet the definition of an adverse event include: 
• The disease/disorder being studied, or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the patient’s 
condition; 
• Medical or surgical procedure (e.g., endoscopy, appendectomy) should be entered into 
the electronic case report form (eCRF).  If not planned prior to signing the informed 
consent, the condition that leads to the procedure is reported as an adverse or serious 
event, as appropriate.  Periodic procedures for routine maintenance of a medical device 


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should not be considered associated with an adverse event (e.g., expected change of a 
stent); 
• Situations where an untoward medical occurrence did not occur (e.g., planned 
hospitalization for an elective procedure, with elective defined as known or planned at the 
time of signing of the informed consent; social and/or convenience admission to a 
hospital); 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
Adverse events that occur during the study should be evaluated by the Investigator and assessed 
for causal relationship to Study Treatment and severity, as described in Section 8.4 and 
Section 8.5.  Episodic adverse events, such as vomiting, or those that occur repeatedly over a 
period of consecutive days are “intermittent”.  All other events are “continuous”.  Additional 
information on detecting, documenting, and reporting adverse events and serious adverse events 
are provided below.  No toxicity-related dose reductions of Study Treatment are permitted; 
however, Study Treatment can be held for a period of up to 21 days for evaluation and treatment 
of an adverse event.  The Study Treatment may be restarted if deemed safe for the patient by the 
Investigator. 
8.2. 
Definition of a Serious Adverse Event 
If an event is not an adverse event per Section 8.1, then it cannot be a serious adverse event if 
serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, 
death due to progression of disease, etc.).  A serious adverse event is any untoward medical 
occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
c. NOTE:  The term 'life-threatening' in the definition of 'serious' refers to an event in 
which the patient was at risk of death at the time of the event.  It does not refer to an 
event, which hypothetically might have caused death, if it were more severe. 
d. Requires hospitalization or prolongation of existing hospitalization 
e. NOTE:  In general, hospitalization signifies that the patient has been detained 
(usually involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the physician’s 
office or out-patient setting.  Complications that occur during hospitalization are 
adverse events.  If a complication prolongs hospitalization or fulfills any other serious 
criteria, the event is serious.  When in doubt as to whether “hospitalization” occurred 
or was necessary, the adverse event should be considered serious. 
f. Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
g. Results in disability/incapacity 
h. NOTE:  The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions.  This definition is not intended to include experiences 
of relatively minor medical significance such as uncomplicated headache, nausea, 
vomiting, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may 


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interfere or prevent everyday life functions but do not constitute a substantial 
disruption. 
i. Is a congenital anomaly/birth defect 
j. Medical or scientific judgment should be exercised in deciding whether reporting is 
appropriate in other situations, such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize 
the patient or may require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition.  These should also be considered serious.  
Examples of such events are invasive or malignant cancers, intensive treatment in an 
emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency 
or drug abuse. 
8.3. 
Adverse Event Reporting 
The Investigator or site staff is responsible for detecting, documenting, and reporting events that 
meet the definition of an adverse event or serious adverse event. 
The reporting of serious adverse events by the Sponsor (Urovant Sciences GmbH) to regulatory 
authorities is a requirement and each authority has a timetable for reporting these events based 
upon established criteria.  Likewise, it is the responsibility of the Investigator to report serious 
adverse events to their local IRB, REB, or IEC, as required by their local IRB/REB/IEC 
requirements. 
Care will be taken not to introduce bias when detecting adverse events and/or serious adverse 
events.  Open-ended and non-leading verbal questioning of the patient is the preferred method to 
inquire about adverse event occurrence.  Appropriate questions include: 
• • “How are you feeling?” 
• • “Have you had any (other) medical problems since your last visit/contact?” 
• • “Have you taken any new medicines, other than those provided in this study, since 
your last visit/contact? 
The patient’s diary entries and responses to questionnaires used in the study will not be used as a 
primary means to collect adverse events however, they should be reviewed by the study site 
personnel and the study monitors.  Should the Investigator or site staff become aware of a 
potential adverse event through the information collected with these instruments, proper follow-
up with the patient for medical evaluation should be undertaken.  Through this follow-up, if it is 
determined that an adverse event not previously reported has been identified, normal reporting 
requirements should be applied. 
All patients who experience an adverse event will be evaluated at appropriate time intervals and 
followed until the event resolves, becomes stable or chronic, or the patient is deemed lost to 
follow-up.  At the conclusion of the study, the Investigator and medical monitor will assess 
unresolved adverse events and determine if additional/continued follow-up is warranted. 
All adverse events, whether related to the Study Treatment or not, must be fully and completely 
documented on the adverse event case report form and in the patient’s source documents.  In 
addition, any adverse event resulting in permanent treatment discontinuation must be recorded 


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on the appropriate case report form as well as documented in the patient’s source documents.  
Adverse event terms should include a diagnosis, as available, in preference to listing the 
individual signs and symptoms.  If the diagnosis is not known, the Investigator should record 
each sign and symptom as an individual adverse event. 
Reporting for overdose and for pregnancy in the patient or patient’s partner will be reported as 
described in Section 8.3.3 and Section 8.7, respectively. 
8.3.1. 
Period for Reporting Adverse Events 
Adverse events and serious adverse events will be collected from the time a patient takes the first 
dose of Study Treatment in the RVT-901-3004 study until the Follow-up Visit is completed 
approximately 28 days after the last dose of Study Treatment or the date of initiation of another 
investigational agent, an alternate therapeutic drug for overactive bladder, or surgical 
intervention for overactive bladder, whichever occurs first.  Events that occurred prior to the 
patient taking to the first dose of Study Treatment in the RVT-901-3004 study but after the 
patient provided informed consent to participate in the RVT-901-3003 study will be reported 
under the RVT-901-3003 study.  Serious adverse events reported to the Investigator after the 
safety reporting period should be reported to the Sponsor if the Investigator assesses the event as 
related to Study Treatment. 
Reporting instructions for serious adverse events are provided in Section 8.3.2. 
8.3.2. 
Reporting Serious Adverse Events 
All serious adverse events must be reported in the eCRF within 24 hours of the study site 
personnel’s knowledge of the event, regardless of the Investigator assessment of the 
relationship of the event to Study Treatment. 
The event term, start date, severity, and initial causality assessment must be entered in the 
Adverse Event eCRF page and the event must be marked as “Serious”.  This will activate 
additional assessment fields including “action taken with study drug”, “seriousness criteria”, and 
“brief description” which should be completed as soon as information is available.  Marking the 
event as “serious” will automatically send required notifications for Sponsor review. 
The initial serious adverse event report should include: 
• The date of the report; 
• A description of the serious adverse event (event term, seriousness of the event, date 
of onset, intensity); and 
• Causal relationship to the Study Treatment. 
A discharge summary should be provided for all hospitalizations.  If the patient died, the report 
should include the cause of death as the event term (with death as the outcome) and whether the 
event leading to death was related to Study Treatment, as well as the autopsy findings, if 
available. 
Do not delay reporting a suspected serious adverse event to obtain additional information.  Any 
additional information, if collected, can be reported as a follow-up to the initial report. 


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All patients who experience a serious adverse event will be evaluated at appropriate time 
intervals and followed until the event resolves, becomes stable or chronic, or the patient is 
deemed lost to follow-up.  Serious adverse events reported to the Investigator after the safety 
reporting period should be reported to the Sponsor if the Investigator assesses the event as 
related to the Study Treatment. 
8.3.3. 
Study Treatment Overdose Management 
The medical monitor must be contacted in the event of any Study Treatment overdose. 
An overdose is defined as a known deliberate or accidental administration of Study Treatment, to 
or by a study patient, at a dose above that assigned to that individual patient according to the 
study protocol. 
For this study, any dose of > 2 tablets and/or > 2 capsules of blinded Study Treatment within a 
24-hour window is an overdose.  There is no known antidote for an overdose. 
In the event of an overdose, the Investigator or treating physician should: 
• Contact the medical monitor immediately; 
• Closely monitor the patient for adverse events and laboratory abnormalities; 
• Report all overdose that result in an adverse event within 24 hours of awareness by 
the study site, using a serious adverse event form according to Section 8.3.2, whether 
or not the overdose is associated with an adverse event; 
• Overdose events that do not result in an adverse event will be reported as a protocol 
deviation in the eCRF; 
• If possible, obtain a plasma sample for pharmacokinetic analysis within 2 days from 
the date of the last dose of Study Treatment if requested by the medical monitor 
(determined on a case-by-case basis); 
• Document the quantity of the excess dose as well as the duration of the overdosing in 
the eCRF. 
The medical monitor, in consultation with the Investigator, will make decisions regarding patient 
status and potential dose interruptions, based on the clinical evaluation of the patient. 
8.4. 
Assigning Causal Relationship to Study Treatment 
The reasonable possibility of the relationship of an adverse event to Study Treatment is to be 
assessed with careful medical consideration at the time of evaluation of an adverse event.  The 
following definitions are to be used for the relationship of the adverse event to Study Treatment: 
• Probably related:  A clinical event, including laboratory test abnormality, with a 
reasonable time sequence to administration of the drug, unlikely attributed to 
concurrent disease or other drugs or chemicals, or that follows a clinically reasonable 
response on re-administration (re-challenge) or withdrawal (de-challenge). 
• Possibly related:  A clinical event, including laboratory test abnormality, with a 
reasonable time sequence to administration of the drug but that could also be 


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explained by concurrent disease or other drugs or chemicals.  Information on drug 
withdrawal may be lacking or unclear. 
• Not related:  A clinical event, including laboratory test abnormality, with a temporal 
relationship to drug administration that makes a causal relationship improbable and/or 
in which other drugs, chemicals, or underlying disease provide a plausible 
explanation. 
All adverse events, whether related to Study Treatment or not, must be fully and completely 
documented on the adverse event page of the eCRF and in the patient’s clinical record.  In the 
event a patient is withdrawn from the study because of an adverse event, the primary reason for 
withdrawal (i.e., due to an adverse event) must be recorded on the eCRF as such. 
8.5. 
Assigning Severity Rating for Adverse Events 
Severity describes the intensity of a specific event (as in mild, moderate, or severe myocardial 
infarction); the event itself, however, may be of relatively minor medical significance, such as a 
severe headache.  This is not the same as “serious,” which is based on patient/event outcome or 
action taken. 
The Investigator must determine the severity of each adverse event according to the criteria in 
Table 5. 
Table 5 
Criteria for Determining the Grade/Severity of Adverse Event Terms 
Grade 
Criteria 
1/Mild 
Asymptomatic or mild symptoms, clinical or diagnostic 
observations only; intervention not indicated 
2/Moderate 
Minimal, local, or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living 
3/Severe or medically significant 
Not immediately life-threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care activities of 
daily living 
4/Life-threatening 
Life threatening consequences; urgent intervention indicated 
5/Death 
Death related to adverse event 
 
Adverse event severity should be recorded in the appropriate section of the adverse event case 
report form and in the patient’s source documents. 
8.6. 
Adverse Events of Clinical Interest 
Selected non-serious and serious adverse events will be reported as Adverse Events of Clinical 
Interest (AECI) and must be reported within 24 hours of the study site personnel’s knowledge 
of the event as an AECI by marking the appropriate box on the AE eCRF form and assigning the 
most appropriate category.  Additional information requested should be provided as directed in 
the eCRF Completion Guidelines (eCCGs). 


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AECIs that also meet the definition of a serious adverse event must be reported as a serious 
adverse event, as described in Section 8.3.2. 
Adverse Events of Clinical Interest for this study include: 
• 
Potential Major Adverse Cardiac and Cerebrovascular Events (MACCE), which will be 
adjudicated by an independent external expert clinical adjudication committee (CAC) 
into the following categories according to the definitions in the CAC Charter: 
− Death or any event with fatal outcome 
− Myocardial infarction / Heart Attack 
− Cerebrovascular Accident / Stroke 
− Hospitalization for Unstable Angina / Chest Pain 
− Hospitalization for Heart Failure 
− Coronary revascularization / Angioplasty / Stent 
• 
Hypertension: 
An adverse event of hypertension should be reported and will be an AECI as follows: 
− For patients without hypertension (average SBP <140 mmHg, DBP <90 mmHg) 
at baseline, at two consecutive visits, the average of three systolic blood pressure 
(SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg (or both); at 
2 consecutive visits in patients who were not hypertensive at baseline; or, 
− For patients with hypertension at baseline, an increase compared to baseline at 
2 consecutive visits in the average of three SBP by ≥20 mmHg OR DBP 
by ≥10 mmHg;  
− Initiation of, or increase in dose of, medication for treatment of hypertension in 
any patient. 
• 
Adverse events consistent with orthostatic hypotension as confirmed by orthostatic vital 
signs. 
• 
Adverse events suggestive of cystitis or urinary tract infection. 
• 
Elevated AST or ALT lab value requiring that study drug be temporarily withheld or 
permanently discontinued (see Section 8.6.1 and Section 8.6.2). 
8.6.1. 
Criteria for Temporary Withholding of Study Treatment in Association with 
Liver Test Abnormalities 
Elevated liver enzymes or bilirubin sufficient to require withholding study medication must be 
reported within 24 hours of the study site personnel’s knowledge of the event using AECI 
specific CRFs/forms/worksheets provided for the study. 
Hepatic enzymes will be monitored in accordance with FDA drug-induced liver injury guidelines 
[FDA, 2009]. 


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If the following liver test abnormalities develop, Study Treatment should be withheld 
immediately with appropriate clinical follow-up (including repeat laboratory tests, until a 
patient’s laboratory profile has returned to normal/baseline status), and the event reported as a 
serious adverse event: 
• ALT or AST > 8 x ULN; or 
• ALT or AST > 5 x ULN and persists for more than 2 weeks; or 
• ALT or AST > 3 x ULN and total bilirubin > 2 x ULN or international normalized 
ratio (INR) >1.5 
• ALT or AST > 3 x ULN with appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%). 
Rechallenge may be considered if an alternative cause for the abnormal liver tests (ALT, AST, 
total bilirubin) is discovered and the laboratory abnormalities resolve to normal or baseline 
values.  The Investigator and Sponsor must discuss and agree with any decision to rechallenge. 
Rechallenge should not occur when the etiology of the liver test abnormalities is considered 
possibly drug induced. 
8.6.2. 
Criteria for Permanent Discontinuation of Study Treatment in Association with 
Liver Test Abnormalities 
Study treatment should be discontinued permanently if all of the following 4 criteria are met 
(i.e., potential severe drug-induced liver injury/Hy’s law case): 
1. Total bilirubin increases to > 2 x ULN or INR > 1.5; AND 
2. AST or ALT increases to ≥ 3 x ULN; AND 
3. Alkaline phosphatase value does not reach 2 x ULN; AND 
4. No alternative cause explains the combination of the above laboratory abnormalities; 
important alternative causes include, but are not limited to the following: 
• Hepatobiliary tract disease; 
• Viral hepatitis (e.g., hepatitis A/B/C/D/E, Epstein-Barr virus); 
• Exposure to hepatotoxic agents/drugs or hepatotoxins, including herbal and dietary 
supplements, plants, and mushrooms; 
• Alcoholic hepatitis; 
• Non-alcoholic steatohepatitis; or 
• Autoimmune hepatitis. 
If an alternative cause for hepatotoxicity is identified, then it should be determined (based on the 
severity of the hepatotoxicity or event) whether Study Treatment should be withheld or 
permanently discontinued as appropriate for the safety of the patient. 


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8.7. 
Pregnancy Management and Reporting to the Sponsor 
If any patient or female partner of a patient becomes pregnant during the study, the site must 
discontinue the patient from Study Treatment immediately and have the patient return for an 
Early Withdrawal Visit (Week 52 Visit activities).  The Investigator must inform the patient of 
their right to receive treatment information.  If the patient chooses to receive unblinded treatment 
information, the individual blind should be broken and the treatment assignment provided to the 
patient.  The study team will remain blinded to the patient’s treatment assignment. 
In the case of a pregnant patient, if she agrees, the Investigator should notify the patient’s 
primary care physician of the pregnancy and provide details of the patient’s participation in the 
study and treatment (blinded or unblinded, as applicable). 
In the case of a male patient with a pregnant partner, if the patient agrees, the patient’s pregnant 
partner should be notified and requested to sign a Release of Information form, permitting 
transfer of information regarding the pregnancy and outcome to the Sponsor. 
A pregnancy is to be reported to the Sponsor within 24 hours of awareness by the study site 
personnel, using the pregnancy reporting forms and the contact information in Section 8.3.2.  
The expected date of delivery or expected date of the end of the pregnancy, last menstruation, 
estimated conception date, pregnancy result, neonatal data, etc.  should be included in this 
information, as available. 
The Investigator will follow the medical status of the mother, the pregnancy, as well as the 
outcome of the infant at birth, and will report the outcome to the Sponsor. 
8.8. 
Benefit/Risk Assessment 
Patients may not expect to receive direct benefit from treatment during participation, as this 
study is designed to provide information about the safety and effectiveness of an investigational 
medicine compared to placebo.  Some patients will receive tolterodine, an approved medication 
for treating overactive bladder with symptoms of urinary frequency, urgency, and leakage. 
Additional details about vibegron may be found in the current vibegron Investigator’s Brochure 
(IB) and Informed Consent documents. 


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9. 
STATISTICAL CONSIDERATIONS 
This section contains a brief summary of the statistical analyses for this study; full details shall 
be provided in the Statistical Analysis Plan. 
9.1. 
Responsibility for Analyses/In-House Blinding 
The statistical analysis of the data obtained from this study will be the responsibility of the 
designee of the Sponsor. 
The study will be conducted as a double-blind, Sponsor open (partially unblinded) study as 
described in Section 6.4. 
At the end of the study (including the period of 28 days follow-up), the official, final database 
will be frozen and unblinded after medical/scientific review has been performed, and data have 
been declared final and complete.  A Statistical Analysis Plan will be approved prior to data 
being unblinded.  A clinical study report will be prepared after all patients complete the study. 
9.2. 
Hypotheses 
9.2.1. 
Primary Objective and Hypotheses 
The primary objective will be to demonstrate the long-term safety of vibegron 75 mg in patients 
with symptoms of OAB.  There is no formal statistical primary endpoint hypothesis.  Rather, 
incidence of treatment-emergent AEs by system organ class and preferred term will be 
descriptively summarized by treatment group based on study RVT-901-3004. 
9.2.2. 
Secondary Objectives 
There are no formal statistical hypotheses for this trial.  Below are the secondary efficacy 
objectives of this trial. 
(1) 
Objective:  To evaluate the efficacy of vibegron in reducing the average number of 
daily micturitions from baseline at Week 52 in all patients with OAB. 
(2) 
Objective:  To evaluate the efficacy of vibegron in reducing the average number of 
daily UUI episodes from baseline at Week 52 in all patients with OAB. 
(3) 
Objective:  To evaluate the efficacy of vibegron in reducing the average number of 
urgency episodes from baseline at Week 52 in all patients with OAB. 
(6) 
Objective:  To evaluate the efficacy of vibegron in reducing the average number of 
total urinary incontinence episodes from baseline at Week 52 in all patients with 
OAB Wet. 


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9.3. 
Analysis Endpoints 
The descriptions of the endpoints and time points at which they are measured are described in 
Section 3 and Section 1.1 (Schedule of Activities), respectively. 
No formal statistical comparisons of vibegron vs. tolterodine are planned.  Any statistical 
analyses will be considered descriptive. 
9.3.1. 
Efficacy Endpoints 
For the purpose of this study, the number of micturitions will be defined as the number of times a 
patient has voided in the toilet as indicated on the Voiding Diary.  Average daily micturitions are 
calculated using the daily entries in the Voiding Diary, which is completed prior to each study 
visit.  Average daily number of micturitions will be calculated as the total number of micturitions 
that occur on a Complete Diary Day divided by the number of Complete Diary Days in the 
Voiding Diary.  A “Complete Diary Day” is defined as a Diary Day that includes input of 
micturition data by patients on the voiding diary.  Unless a patient indicated “No” to the 
questions of “Did you record each time you urinated or leaked during this Diary Day”, the Diary 
Day is considered complete.  Baseline is defined as the average number of micturitions occurring 
during the week of Run-in prior to the Baseline Visit in study RVT-901-3003.  If data from the 
study RVT-901-3003 Run-in are not available for a patient, data collected during Screening will 
serve as the baseline. 
The number of UUI episodes will be defined as the number of times a patient has checked "urge" 
as the reason for accidental urine leakage.  Average daily urge urinary incontinence episodes at 
each study visit will be calculated in the same manner as described above for the micturition 
endpoint.  The urge urinary incontinence endpoint will be analyzed using only OAB Wet 
patients. 
Secondary Endpoints: 
• Change from baseline (CFB) at Week 52 in average number of micturitions per 
24 hours in all OAB patients 
• CFB at Week 52 in average number of urge urinary incontinence (UUI) episodes per 
24hours in OAB Wet patients 


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• CFB at Week 52 in average number of urgency episodes (need to urinate 
immediately) over 24 hours in all OAB patients 
• CFB at Week 52 in average number of total urinary incontinence episodes over 24 
hours in OAB Wet patients 
Exploratory Endpoints: 


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9.3.2. 
Safety Endpoints 
Safety and tolerability will be assessed via clinical review of all relevant safety parameters 
including clinical adverse events, clinical laboratories, vital signs, and physical examinations that 
occurred during the respective study period. 
9.4. 
Analysis Populations 
9.4.1. 
Efficacy Analysis Populations 
The Full Analysis Set Extension (FAS-Ext) population will serve as the population for the 
analysis of efficacy data in this study.  Since the endpoints related to incontinence would only 
apply to patients who meet the definition of incontinence at study entry, it is necessary to have a 
separate FAS definition with an additional criterion to define the analysis population for 
incontinence endpoints. 
The following FAS populations are defined in the study: 
• Full analysis set extension (FAS-Ext):  all OAB patients who took at least one dose of 
double-blind Study Treatment in the current study and have at least one evaluable 
change from baseline micturition measurement in this study 
• Full analysis set extension for incontinence (FAS-Ext-I):  all OAB Wet patients who 
took at least one dose of double-blind Study Treatment in the current study and have 
at least one evaluable change from baseline urge urinary incontinence measurement 
in this study 
The Per-Protocol extension population (PP-Ext) and Per-Protocol extension population for 
incontinence (PP-Ext-I) exclude patients due to important deviations from the protocol that may 
substantially affect the results of the efficacy endpoints.  A supportive analysis using the Per-


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Protocol populations will be performed for the 4 key secondary efficacy endpoints.  The final 
determination on protocol violations, and thereby the composition of the Per-Protocol 
population, will be made prior to the unblinding of the database and will be documented in a 
separate memo. 
Patients will be included in the treatment group to which they are randomized to for the analysis 
of efficacy data using the Full Analysis Set and Per-Protocol populations.  Efficacy endpoints 
will be descriptively summarized by treatment group based on treatment in both RVT-901-3003 
and study RVT-901-3004.  This means there will be 4 treatment groups including vibegron for 
52 weeks, tolterodine for 52 weeks, vibegron for 40 weeks, and tolterodine for 40 weeks. 
9.4.2. 
Safety Analysis Populations 
The Safety Analysis (SAF) population will be used for the analysis of safety data in this study.  
The SAF population consists of all patients who received at least one dose of Study Treatment in 
this study.  Patients will be included in the treatment group corresponding to the Study Treatment 
they actually received for the analysis of safety data using the SAF population.  For most 
patients, this will be the treatment group to which they were randomized.  Patients who take 
incorrect Study Treatment for the entire Treatment Period will be included in the treatment group 
corresponding to the Study Treatment actually received.  Safety endpoints will be descriptively 
summarized based on treatment in study RVT-901-3004.  This means there will be 2 treatment 
groups including vibegron (52 weeks and 40 weeks combined) and tolterodine (52 weeks and 
40 weeks combined). 
At least one laboratory or vital sign measurement obtained subsequent to at least one dose of 
Study Treatment is required for inclusion in the analysis of each specific parameter.  To assess 
change from baseline, a Baseline measurement is also required. 
No imputation will be performed for missing safety data.  Baseline will be defined as the last 
non- missing value before double-blind treatment in study RVT-901-3003.  Further inclusion of 
data from RVT-901-3003 in the reporting of this study will be described in the SAP. 
9.5. 
Statistical Methods 
9.5.1. 
Statistical Methods for Efficacy Analyses 
Secondary Endpoints:  Efficacy 
Statistical analysis of efficacy endpoints will be for descriptive purposes only.  Baseline will be 
the RVT-901-3003 baseline.  Further inclusion of data from RVT-901-3003 in the reporting of 
this study will be described in the SAP. 
For the analysis of continuous change from baseline endpoints (e.g., change from baseline in 
average number of daily micturitions, change from baseline in average number of daily urge 
urinary incontinence episodes, change from baseline in average number of urgency episodes, and 
change from baseline in average number of total incontinence episodes), a mixed model for 
repeated measure (MMRM) with restricted maximum likelihood estimation will be used.  This 
model corrects for dropout and accounts for the fact that measurements taken on the same patient 
over time tend to be correlated, by using all available information on patients within the same 
covariate set to derive an estimate of the treatment effect for a dropout-free population.  The 


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analysis model for each efficacy endpoint will include terms for treatment, visit, baseline 
stratification factors (only those that were statistically significant in RVT-901-3003 will be 
included in the models), baseline score, and interaction of visit by treatment.  Only patients on 
active treatment in both RVT-901-3003 and RVT-901-3004 will be included in the model. 
Adjusted means and 95% confidence intervals will be presented for each visit and each treatment 
group.  No p-values and no treatment differences will be presented. 
An unstructured covariance matrix will be used to model the correlation among repeated 
measurements.  The Kenward-Roger adjustment will be used with restricted (or residual) 
maximum likelihood (REML) to make proper statistical inference.  If the unstructured 
covariance model fails to converge with the default Newton-Raphson algorithm, the Fisher 
scoring algorithm or other appropriate methods can be used to provide initial values of the 
covariance parameters.  In the rare event that none of the above methods yield convergence, a 
structured covariance will be used to model the correlation among repeated measurements. 
9.5.2. 
Statistical Methods for Safety Analyses 
Safety analyses will be conducted using the safety population and summarized by treatment 
group as treated.  The treatment-emergent period will be defined as the period of time from the 
first dose date of the double blinded Study Treatment in this study through 28 days after the last 
dose of Study Treatment, or the date of initiation of another investigational agent or surgical 
intervention, whichever occurs first.  Safety will be assessed through summaries of adverse 
events, the frequency of treatment discontinuations due to adverse events, and clinical laboratory 
evaluations. 
The severity of all adverse events will be evaluated by the Investigator as described in 
Section 8.5.  All adverse events will be coded to preferred term and system organ class using 
MedDRA 20.0 or higher.  The incidence of adverse events will be presented by MedDRA system 
organ class and preferred term, relationship to Study Treatment, and severity. 
Laboratory data will consist of chemistry, hematology, and urinalysis data.  Only data collected 
by the central laboratory will be included in the analyses. 
Vital signs parameters, including temperature, will be listed and summarized by visit. 
9.6. 
Multiplicity 
All efficacy endpoints will be considered descriptive and no multiplicity adjustments will be 
performed for these endpoints. 
9.7. 
Sample Size Determination 
Five hundred (500) patients rolling over from study RVT-901-3003, in addition to other long-
term safety data with vibegron, is sufficient to characterize the long-term safety profile of 
vibegron 75 mg once daily and satisfies the ICH guidance for 1-year exposure. 
9.8. 
Interim Analyses 
There is no planned interim analysis for efficacy. 


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10. 
STUDY GOVERNANCE CONSIDERATIONS 
10.1. 
Financial Disclosure 
Financial disclosure requirements are outlined by the US Code of Federal Regulations Title 21, 
Part 54 (21 CFR 54), Financial Disclosure by Clinical Investigators.  It is the Sponsor's 
responsibility to determine, based on these regulations, whether a request for financial disclosure 
information is required.  It is the Investigator's and Sub-Investigator's responsibility to comply 
with any such request. 
This is a “covered clinical study”, defined under 21 CFR 54 as “any study of a drug or device in 
humans submitted in a marketing application or reclassification petition patient to this part that 
the applicant or FDA relies on to establish that the product is effective (including studies that 
show equivalence to an effective product) or any study in which a single Investigator makes a 
significant contribution to the demonstration of safety.”  As such, all Investigators and Sub-
Investigators must provide documentation of their financial interest or arrangements with the 
Sponsor, or proprietary interests in the drug being studied.  This documentation must be provided 
before participation of the Investigator and any Sub-Investigator.  The Investigator and Sub-
Investigator agree to notify the Sponsor of any change in reportable interests during the study 
and for 1 year following completion of the study. 
10.2. 
Data Management 
Patient data will be entered into a Sponsor-approved electronic database and combined with data 
provided from other sources in validated datasets then transmitted electronically to the Sponsor 
or designee. 
Management of clinical data will be performed in accordance with applicable Sponsor-approved 
standards and data cleaning procedures to ensure the integrity of the data (e.g., errors will be 
corrected and inconsistencies clarified). 
Adverse events and concomitant medications terms will be coded using the most current versions 
of the MedDRA (i.e., 20.0 or higher) and the World Health Organization Drug Dictionary 
Enhanced (WHO-DDE), respectively. 
The Investigator will retain original source documents and the Sponsor will receive eCRF-
required data as electronic datasets.  Patient initials will not be collected or transmitted to the 
Sponsor. 
10.3. 
Monitoring 
This study will be monitored by the Sponsor (or designee) in accordance with current GCP 
regulations.  By signing this protocol, the Investigator grants permission to the Sponsor (or 
designee) and appropriate regulatory authorities to conduct on-site monitoring of all appropriate 
study documentation.  In order to verify the accuracy of data collected in the eCRF, the monitor 
will require direct access to original source documents (e.g., patient records, patient charts, and 
laboratory reports). 
During the review of these documents, the anonymity of the patient will be respected with strict 
adherence to professional standards of confidentiality.  A study monitor will contact and visit the 


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site regularly and will be allowed, on request at a mutually acceptable time, to inspect the various 
records of the study.  It will be the study monitor’s responsibility to inspect the eCRF at regular 
intervals throughout the study, to verify the adherence to the protocol and the completeness, 
correctness, and accuracy of all eCRF entries, and to meet with the Investigator to discuss study 
progress and compliance with the protocol and GCP.  The study monitor should have access to 
laboratory test results and any other source records and data needed to verify the entries on the 
eCRF.  The Investigator agrees to cooperate with the study monitor to ensure that any problems 
detected in the course of these monitoring visits are resolved. 
10.4. 
Auditing or Inspections 
Representatives of regulatory authorities, health authorities, the Sponsor, or IRB/REB/IEC’s may 
conduct inspections or audits of the clinical study.  If the Investigator is notified of an inspection 
by a regulatory authority, the Investigator agrees to notify the Sponsor’s medical monitor 
immediately.  By signing this protocol, the Investigator agrees to provide to appropriately 
qualified personnel from such groups, access to records, facilities, and personnel for the effective 
conduct of any inspection or audit. 
10.5. 
Study Oversight Committees 
10.5.1. 
Clinical Adjudication Committee 
As noted in Section 8.6, MACCE event diagnosis will be adjudicated by an independent external 
expert committee. 
10.5.2. 
Steering Committee 
A Steering Committee may be formed, if deemed necessary.  If formed, the committee will be 
comprised of both Sponsor and non-Sponsor scientific experts who will participate in the design, 
conduct, analyses, and publication of the study.  Steering Committee members will remain 
blinded to patients’ treatment assignments and all unblinded data until the database is officially 
locked and unblinded. 
10.6. 
Protocol Modifications 
Protocol modifications, except those intended to reduce immediate risk to patients, may be made 
only by the Sponsor.  All protocol modifications must be submitted to the IRB/REB/IEC in 
accordance with local requirements.  Approval must be obtained before changes can be 
implemented.  The Investigator must not deviate from the protocol without first obtaining 
approval from the Sponsor and the IRB/REB/IEC, if required.  In medical emergencies, the 
Investigator will use medical judgment and will remove the patient from immediate hazard, then 
notify the Sponsor (or designee) and the IRB/REB/IEC immediately regarding the type of 
emergency and the course of action taken.  The Investigator must notify the Sponsor (or 
designee) of any inadvertent protocol deviations upon their discovery, and document the 
deviations appropriately in the study files. 
When a protocol amendment substantially alters the study design or the potential risks or burden 
to patients, the informed consent form will be amended and approved by the IRB/REB/IEC, and 
all patients on treatment will again provide informed consent. 


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10.7. 
Study Discontinuation 
The Sponsor reserves the right to terminate the study at any time.  Should this be necessary, the 
Sponsor will arrange discontinuation procedures and notify the appropriate regulatory 
authority(ies) and IRB/REB/IEC.  In terminating the study, the Sponsor and the Investigator will 
assure that adequate consideration is given to the protection of the study participants’ interests. 
10.8. 
Publications 
After conclusion of the study and without prior written approval from the Sponsor, Investigators 
in this study may communicate, orally present, or publish in scientific journals or other scholarly 
media only after the following conditions have been met: 
• The results of the study in their entirety have been publicly disclosed by or with the 
consent of the Sponsor in an abstract, manuscript, or presentation form; or 
• The study has been completed at all study sites for at least 5 years. 
No such communication, presentation, or publication will include Urovant Sciences GmbH 
confidential information (see Section 10.9.5). 
The Investigator will submit to the Sponsor any proposed publication or presentation along with 
the respective target scientific journal or presentation forum at least 30 days before submission of 
the publication or presentation.  The Investigator will comply with Sponsor requests to delete 
references to its confidential information (other than the study results) in any paper or 
presentation and agrees to withhold publication or presentation for an additional 60 days in order 
to obtain patent protection if deemed necessary. 
10.9. 
Investigator-Specific Responsibilities 
10.9.1. 
Compliance with Regulations and Ethical Standards 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
“Declaration of Helsinki” (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South 
Africa), ICH guidelines, or with the laws and regulations of the country in which the research is 
conducted, whichever affords the greater protection to the study participant.  For studies 
conducted under a United States investigational new drug application, the Investigator will 
ensure that the basic principles of GCP, as outlined in 21 Code of Federal Regulations 
(CFR 312), subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, 1998, 
and 21 CFR, part 56, 1998, are adhered to.  These standards are consistent with the requirements 
of the European Community Directive 2001/20/EC. 
The Investigator will also comply with financial disclosure requirements as described in 
Section 10.1. 
10.9.2. 
Protocol Compliance 
The Investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. 


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10.9.3. 
Institutional Review Board/Independent Ethics Committee Requirements 
The protocol, protocol amendments, informed consent form, IB, and any other relevant 
materials, including accompanying material to be provided to the patient (e.g., advertisements, 
patient information sheets, or descriptions of the study used to obtain informed consent) will be 
submitted by the Investigator to an IRB/REB/IEC.  Approval from the IRB/REB/IEC must be 
obtained before starting the study and should be documented in a letter to the Investigator 
specifying the following: 
• Protocol number; 
• Protocol version; 
• Protocol date; 
• Documents reviewed; and 
• Date on which the committee met and granted the approval. 
Any amendments to the protocol will require IRB/REB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
The Investigator will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB/REB/IEC’s 
annually or more frequently in accordance with the requirements, policies, and 
procedures established by the IRB/REB/IEC; 
• Notifying the IRB/REB/IEC of serious adverse events or other significant safety 
findings as required by procedures established by the IRB/REB/IEC. 
10.9.4. 
Informed Consent 
The Investigator (or designee) is responsible for obtaining written informed consent from each 
study participant prior to any study activities.  To help the individual make an informed decision 
about participating, the Investigator (or designee) shall discuss with the potential participant the 
purpose of the research, procedures, risks, benefits, alternative options to participating, 
confidentiality, how to contact study personnel, and the patient’s rights.  Potential participants 
must be informed that their participation is voluntary and must be given ample time to ask the 
Investigator questions and obtain clarifications regarding the study prior to providing consent. 
The Investigator must utilize an IRB/REB/IEC-approved informed consent form for 
documenting written informed consent that contains all elements required by national, state, 
local, and institutional regulations or requirements.  Each informed consent form will be 
appropriately signed and dated by the patient or the patient’s legally authorized representative 
and the person obtaining consent. 
As described in Section 10.6, patients must be re-consented to participate in the study if a 
protocol amendment is made that substantially alters the study design or the potential risks or 
burden to patients. 


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10.9.5. 
Confidentiality 
The Investigator must assure that patients’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties.  Only patient number (i.e., not names) and 
date of birth (as allowed) should be recorded on any form or biological sample submitted to the 
Sponsor, IRB/REB/IEC, or laboratory.  The Investigator must keep a Screening log showing 
codes, names, and addresses for all patients screened and for all patients enrolled in the study. 
The Investigator agrees that all information received from the Sponsor, including, but not limited 
to, the IB, protocol, eCRFs and other study forms, the investigational drug, and any other study 
information, remain the sole and exclusive property of the Sponsor during the conduct of the 
study and thereafter.  This information is not to be disclosed to any third party (except employees 
or agents directly involved in the conduct of the study or as required by law) without prior 
written consent from the Sponsor.  The Investigator further agrees to take all reasonable 
precautions to prevent the disclosure by any employee or agent of the study site to any third 
party or otherwise into the public domain. 
10.9.6. 
Study Files and Retention of Records 
The Investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified.  These documents should 
be classified into at least the following two categories: 
1. Investigator’s study file.  The Investigator’s study file will contain the IB, 
protocol/amendments, IRB/REB/IEC and governmental approval with correspondence, 
informed consent forms, drug records, staff curriculum vitae, authorization and training 
forms, and other appropriate documents and correspondence. 
2. Patient clinical source documents.  The required source data should include the following 
for each patient: 
• Patient identification (name, date of birth, sex); 
• Documentation that the patient meets eligibility criteria, (e.g., history, physical 
examination, and confirmation of diagnosis to support inclusion and exclusion 
criteria); 
• Participation in the study (including study number); 
• Study discussed and date of informed consent; 
• Dates of all visits; 
• Documentation that protocol-specific procedures were performed; 
• Results of efficacy parameters, as required by the protocol; 
• Start and end date (including dose regimen) of Study Treatment (drug dispensing and 
return should be documented as well); 
• Record of all adverse events and other safety parameters (start and end date, and 
causality and intensity as assigned by the Investigator); 
• Concomitant medication (including start and end date); and 


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• Date of study completion and reason for early discontinuation, if applicable. 
All clinical study documentation must be retained by the Investigator until at least 2 years after 
the last approval of a marketing application in an ICH region (i.e., United States, Europe, or 
Japan) and until there are no pending or contemplated marketing applications in an ICH region; 
or, if no application is filed or if the application is not approved for such indication, until 2 years 
after the investigation is discontinued and regulatory authorities have been notified.  
Investigators may be required to retain documents longer if required by applicable regulatory 
requirements, by local regulations, or by an agreement with the Sponsor.  The Investigator must 
notify the Sponsor before destroying any clinical study records. 
Clinical study documentation includes the IB, signed protocol and amendments, signed informed 
consents, notification of serious adverse events and related reports, any dispensing and 
accountability logs, shipping records of investigational product and study-related materials, 
documentation of financial aspects of the study, insurance statement, and signed agreement 
between the involved parties, dated and documented IRB/REB/IEC approval, approval of 
regulatory authorities as applicable, decoding procedures for blinded studies, curriculum vitae 
and all training records of study site personnel, and all correspondence pertaining to the conduct 
of the study. 
Should the Investigator wish to assign the study records to another party or move them to another 
location, the Sponsor must be notified in advance. 
If the Investigator cannot guarantee this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the Investigator and the Sponsor to 
store these in sealed containers outside of the site so that they can be returned sealed to the 
Investigator in case of a regulatory audit.  When source documents are required for the continued 
care of the patient, appropriate copies should be made for storage outside of the site. 
10.9.7. 
Electronic Case Report Forms 
For each patient enrolled, an eCRF must be completed and signed by the Investigator or 
Sub-Investigator (as appropriate) listed on Food and Drug Administration Form 1572 and/or 
other appropriate local health authority documents within a reasonable time period after data 
collection.  This also applies to records for those patients who fail to complete the study (even 
during a pre-randomization Screening Period if an eCRF was initiated).  If a patient withdraws 
from the study, the reason must be noted on the eCRF.  If a patient is withdrawn from the study 
because of a treatment-limiting adverse event, thorough efforts should be made to clearly 
document the outcome. 
10.9.8. 
Investigational Product Accountability 
The Investigator or Investigator’s designee (e.g., pharmacist) is responsible for ensuring 
adequate accountability (including dates and lot numbers) of all used and unused Study 
Treatment (active and placebos).  This includes acknowledgment of receipt of each shipment of 
study product (quantity and condition), patient dispensing records, and returned or destroyed 
study product.  Dispensing records will document quantities received from the Sponsor and 
quantities dispensed to patients, including lot number, date dispensed, Patient Number, and the 
initials of the person dispensing the Study Treatment. 


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At study initiation, the study monitor will evaluate the site’s standard operating procedure for 
investigational medicinal product disposal/destruction in order to ensure that it complies with the 
Sponsor requirements.  Drug may be returned (by the monitor) or destroyed on-site, if 
appropriate per site standard operating procedures (SOPs).  At the end of the study, following 
final drug inventory reconciliation by the monitor, the study site will dispose of and/or destroy 
all unused Study Treatment supplies, including empty containers, according to these procedures.  
If the site cannot meet the Sponsor’s requirements for disposal, arrangements will be made 
between the site and the Sponsor (or designee) for destruction or return of unused investigational 
medicinal product supplies. 
All drug supplies and associated documentation will be periodically reviewed and verified by the 
study monitor over the course of the study. 
10.10. 
Sponsor-Specific Responsibilities 
10.10.1. 
Study Report 
A clinical study report will be prepared and provided to the regulatory authorities.  The Sponsor 
will ensure that the report meets the standards set out in the ICH Guideline for Structure and 
Content of Clinical Study Reports (ICH E3).  Note that an abbreviated report may be prepared in 
certain cases. 
10.10.2. 
Posting of Information on Publicly Available Clinical Trial Registers 
Study information from this protocol will be posted on publicly available clinical trial registers 
before enrollment of patients begins.  Results will be posted as required. 


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11. 
REFERENCES 
1. Abrams P, Cardozo L, Fall M, et al.  The standardisation of terminology of lower urinary 
tract function:  Report from the standardisation sub-committee of the international 
continence society.  Neurourol Urodyn 2002;21:167–78. 
2. Biers SM, Reynard JM and Brading AF.  The effects of a new selective β3- adrenoceptor 
agonist (GW427353) on spontaneous activity and detrusor relaxation in human bladder.  
BJU International 2006;98:  1310-4. 
3. Chapple CR, Nazir J, Hakimi Z, Bowditch S, Fatoye F, Guelfucci F, Khemiri A, Siddiqui 
E, Wagg A.  Persistence and Adherence with Mirabegron versus Antimuscarinic Agents 
in Patients with Overactive Bladder:  A Retrospective Observational Study in UK 
Clinical Practice.  Eur Urol.  2017 Sep;72(3):389-399. 
4. Chapple CR, Kaplan S, Mitcheson HD, Klecka J, Cummings J, Drogendijk T, Dorrepaal 
C, Martin NE.  Randomized, double-blind, active-controlled Phase III study to assess the 
ling-tern safety and effiocacy of mirabegron in overactive bladder (OAB).  Presented at 
European Association of Urology Annual Meeting, February 2012. 
5. Chapple CR, Wyndaele JJ, van Kerrebroeck P, Radziszewski P, Dvorak V, Boerrigter P.  
Dose-ranging study of once-daily mirabegron (YM178), a novel selective β 3-
adrenoceptor agonist, in patients with overactive bladder (OAB).  Poster presentation at 
the 2010 European Urologic Association Annual Meeting, Barcelona, Spain. 
6. Chapple CR, Yamaguchi O, Ridder ALJ, Carl S, Mattiasson A, Aramburu MAL, et al.  
Clinical proof of concept study (BLOSSOM) shows novel β3 adrenoceptor agonist 
YM178 is effective and well tolerated in the treatment of symptoms of overactive 
bladder.  Poster presentation at the 2009 European Urologic Association Annual Meeting, 
Milan, Italy. 
7. D’Souza AO, Smith MJ, Miller L-A, Doyle J, Ariely R.  Persistence, adherence, and 
switch rates among extended-release and immediate-release overactive bladder 
medications in a regional managed care plan.  J Manag Care Pharm 2008;14(3):  
291-301. 
8. FDA Guidance for Industry.  Drug-Induced Liver Injury:  Premarketing Clinical 
Evaluation.  July 2009.  Available at:  
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM174090.pdf.  Accessed:  
11 January 2017. 
9. Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane P, 
Larson, EB.  Cumulative use of strong anticholinergic medications and incident 
dementia.  JAMA Intern Med 2015;175(3):  401-407. 
10. Gray SL, Hanlon JT.  Anticholinergic medication use and dementia:  latest evidence and 
clinical implications.  Ther Adv Drug Saf 2016;7(5):  217-224. 
11. Kaidoh K, Igawa Y, Takeda H, Yamazaki Y, Akahane S, Miyata H, Ajisawa Y, 
Nishizawa O, Andersson KE.  Effects of selective [beta]2 and [beta]3- Adrenoceptor 
agonists on detrusor hyperreflexia in conscious cerebral infarcted rats.  J Urol 2002;168:  
1247-52. 


Clinical Study Protocol 
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Page | 74 
12. Lawrence M, Guay DR, Benson SR, Anderson MJ.  Immediate-release oxybutynin 
versus tolterodine in detrusor overactivity:  a population analysis.  Pharmacotherapy.  
2000;20(4):  470-475. 
13. Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ.  How widespread are 
the symptoms of an overactive bladder and how are they managed?  A population-based 
prevalence study.  BJU International 2001;87:  760-6. 
14. Rabin R, Gudex C, Selai C, Herdman M.  From translation to version management:  a 
history and review of methods for the cultural adaptation of the EuroQol five-
dimensional questionnaire.  Value Health 2014 Jan;17(1):70-76, 01-01-2014. 
15. Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, et al.  
Prevalence and burden of overactive bladder in the United States.  World J Urol 2003;20:  
327-36. 
16. Takeda H, Yamazaki Y, Akahane M, Igawa Y, Ajisawa Y, Nishizawa O.  Role of the β3-
adrenoceptor in urine storage in the rat:  comparison between the selective β3-
adrenoceptor agonist, CL316, 243, and various smooth muscle relaxants.  J Pharm Exp 
Ther 2000;293:  939-45. 
17. Takeda H, Yamazaki Y, Igawa Y, Kaidoh K, Akahane S, Miyata H, Nishizawa O, 
Akahane M, Andersson KE.  Effects of β3-adrenoceptor stimulation on prostaglandin E2-
induced bladder hyperactivity and on the cardiovascular system in conscious rats.  
Neurology and Urodynamics 2002;21:  558-65. 
18. Van Kerrebroeck P, Kreder K, Jonas U, Zinner N, and Wein A.  tolterodine oncedaily:  
superior efficacy and tolerability in the treatment of the overactive bladder.  
Urol 2001;57:  414–21. 
19. Woods M, Carson N, Norton N, Wesley S, Jeffery H, Argentieri TM.  Efficacy of the 
[Beta]3-adrenergic receptor agonist CL-316243 on experimental bladder hyperreflexia 
and detrusor instability in the rat.  J Urol 2001;166:  1142-7. 
20. Yamaguchi O.  β3-adrenoceptors in human detrusor muscle.  Urology 2002;59 
(Supplement 5A):  25-29. 
 


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APPENDICES 


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APPENDIX 1. LIST OF ABBREVIATIONS 
Term 
Description 
AE 
adverse event 
AECI 
Adverse Events of Clinical Interest 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
AR 
adrenergic receptor 
AST 
aspartate aminotransferase 
BP 
blood pressure 
BPH 
benign prostatic hypertrophy 
bpm 
beats per minute 
CAC 
clinical adjudication committee 
cAMP 
cyclic adenosine monophosphate 
CFB 
change from baseline 
CHMP 
Committee for Medicinal Products for Human Use 
CI 
confidence interval 
CT 
computerized tomography 
DBP 
diastolic blood pressure 
DDI 
drug-drug interaction 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
eDiary 
electronic diary 
eGFR 
estimated glomerular filtration rate 
EQ-5D 
European Quality of Life-5 dimension 
ER 
extended release 
EU 
European Union 
FAS-Ext 
full analysis set extension 
FAS-Ext-I 
full analysis set extension for incontinence 
FDA 
(United States) Food and Drug Administration 
GCP 
good clinical practice 
GI 
gastrointestinal 
HRQL 
health-related quality of life 
IB 
Investigator's Brochure 


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Term 
Description 
ICH 
International Conference on Harmonisation of Technical Requirements 
for Registration of Pharmaceuticals for Human Use 
IEC 
institutional ethics committee 
IRB 
institutional review board 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 
IxRS 
interactive voice or web response system 
LF 
long form 
LFT 
liver function tests 
LOCF 
last observation carried forward 
MACCE 
major adverse cardiovascular and cerebrovascular events 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed model for repeated measure 
MRI 
magnetic resonance imaging 
NOAEL 
no-observed-adverse-effect level 
NVU 
nighttime voids associated with urgency 
OAB 
overactive bladder 
OAB-q 
Overactive Bladder Questionnaire 
OAB-q LF 
Overactive Bladder Questionnaire Long Form 
PD 
pharmacodynamic(s) 
PDE 5 
phosphodiesterase type 5 
PGI 
Patient Global Impression 
P-gp 
P-glycoprotein 
PP-Ext 
per-protocol extension population 
PP-Ext-I 
per-protocol extension population for incontinence 
PRO 
patient-reported outcome(s) 
PVR 
patient void residual 
QD 
once daily 
QTc 
corrected QT 
RBC 
red blood cell 
REB 
research ethics board 
REML 
restricted (or residual) maximum likelihood 
SAE 
serious adverse event 


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Term 
Description 
SAF 
safety set 
SAP 
statistical analysis plan 
SBP 
systolic blood pressure 
SOP 
standard operating procedures 
TIA 
transient ischemic attack 
tQT 
thorough QT 
ULN 
upper limit of normal 
Urovant 
Urovant Sciences GmbH 
US 
United States 
UTI 
urinary tract infection 
UUI 
urge urinary incontinence 
WBC 
white blood cell 
WHO-DDE 
World Health Organization Drug Dictionary Enhanced 
WPAI-US 
Work Productivity and Activity Impairment Questionnaire-Urinary 
Symptoms 
β3-AR 
beta-3 adrenergic receptor 
β-AR 
beta adrenergic receptor 
β-hCG 
beta-human chorionic gonadotropin 
 
 
 
 


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APPENDIX 2. ALGORITHM FOR ASSESSING LABORATORY VALUES 
For all laboratory values obtained at pre-study evaluation: 
1. If all values are normal, the patient may enter the study. 
2. If a value is outside the normal range, the following choices are available: 
• The patient may be excluded from the study; 
• The abnormal test may be repeated. 
• The result may be deemed “Not Clinically Significant” and the patient may be 
enrolled in the study. 
3. If the Investigator decides to repeat an abnormal test and if it is within the normal range, 
the patient may enter the study. 
4. If the Investigator decides to repeat an abnormal test and if the repeat test is still 
abnormal, the Investigator will evaluate the potential patient with a complete history and 
physical examination, looking especially for diseases that could result in an abnormality 
in the laboratory value in question.  If such diseases can be excluded, and if the 
Investigator feels that the abnormal laboratory value is not clinically relevant, then the 
patient may enter the study.  The Urovant clinical monitor will be included in the 
decision of whether or not to enroll the patient in the study. 
5. If there is any clinical uncertainty regarding the significance of an abnormal value, the 
patient will be excluded from the study. 
 
 


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APPENDIX 3. APPROXIMATE BLOOD/TISSUE VOLUMES 
DRAWN/COLLECTED BY SAMPLE TYPE 
 
Number of 
collections 
Approximate 
amount per 
collection 
Total Amount 
Hematology 
4 
10 mL 
40 mL 
Serum/Plasma Chemistry 
4 
10 mL 
40 mL 
Total 80 mL 
 
 


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APPENDIX 4. GUIDELINES FOR ELEVATIONS IN HEPATIC 
ENZYMES 
Study treatment should be withheld for any liver test abnormality listed in Section 8.6.1, pending 
investigation of alternative causes of liver injury.  Follow-up should continue until the liver test 
abnormalities resolve to baseline. 
Monitor liver tests per the applicable schedule in Appendix-4 Table 1, and per the investigations 
in Appendix-4 Table 2.  If close monitoring is not possible, Study Treatment should be withheld, 
even if the results do not meet the criteria for withholding in Section 8.6.1. 
The medical monitor should be contacted for questions regarding adequate follow-up tests and 
frequency of follow-up tests for a patient. 
Appendix-4 Table 1 Monitoring of Liver Tests for Potential Drug-Induced Liver Injury 
Results 
Frequency for Repeating Liver (AST, ALT, 
Bilirubin [Total and Direct]), Alkaline 
Phosphatase, and INR Testsa 
If AST or ALT ≥ 3 x ULN and total bilirubin 
> 2 x ULN or INR > 1.5 
Every 24 hours until laboratory abnormalities 
improve 
If ALT or AST ≥ 3 x ULN and total bilirubin and 
INR are normal 
Every 48 to 72 hours until laboratory 
abnormalities improve 
If the liver test abnormalities improve AND the 
patient is asymptomatic 
Frequency may decrease 
Abbreviations:  ALT, alanine aminotransferase; AST, aspartate aminotransferase; INR, international 
normalized ratio; ULN, upper limit of normal 
a. Review frequency of monitoring with medical monitor for an individual patient, in case of questions 
 


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Appendix-4 Table 2 Investigations of Alternative Causes for Abnormal Liver Tests 
Obtain a detailed history and perform a physical examination: 
• Detailed history of symptoms (e.g., right upper quadrant pain, fatigue, nausea, 
vomiting, and fever); 
• Prior and concurrent disease or illnesses; 
• Exposure to environmental (e.g., travel, new sexual exposure, exposure to ill family 
members or coworkers, etc.) and/or industrial chemical agents; 
• Prior and concurrent use of alcohol, recreational drugs, and special diets; 
• Concomitant use of medications (including nonprescription medicines and herbal 
and dietary supplements), plants and mushrooms; 
• Physical examination. 
Recommended tests: 
Also perform additional tests as clinically indicated or in consultation with a gastroenterologist 
or hepatologist. 
• Repeat liver tests as per Appendix-4 Table 1a; 
• Obtain gamma-glutamyl transferase, albumin, INR, and glucose in conjunction 
with repeat liver tests; 
• Complete blood count with differential to assess for eosinophilia; 
• Serum acetaminophen (paracetamol) concentration; 
• Obtain viral serologies for hepatitis A, B, C, D, and E; consider testing for Epstein 
Barr virus; 
• Evaluate for alcoholic hepatitis, nonalcoholic steatohepatitis, biliary tract disease, 
autoimmune hepatitis, etc.; 
• Serology for celiac disease; 
• Appropriate liver imaging; and 
• Hepatology consult (liver biopsy may be considered in consultation with a 
hepatologist or gastroenterologist). 
Abbreviations:  INR, international normalized ratio 
a. If the first follow-up testing does not confirm the initial abnormal liver test results, review any 
additional follow-up monitoring with the medical monitor. 
 
 

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$XJ
Statistical Analysis Plan for lnterventional Studies 
Sponsor: Urovant; Protocol No .. RVT-901 -3004 
I confirm that I have reviewed this document and agree with the content. 
$SSURYDOV
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Signature 
 
Signature 
8URYDQW$SSURYDO
Sponsor Contact 
 on behalf of 
. 
. Programming and 
Data Management 
 
Th1s document IS confidential. 
SAP Vers1on: 2.0 
Controlled Doc• ·ment ID:
Effective Date 29-0ct-2018 
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proc mixed data = data_active_3003 method = reml ; 
class TRTP1 AVISITN USUBJID OABTYPE SEX ; 
model CHG = TRTP1 AVISITN OABTYPE SEX BASE 
TRTP1*AVISITN / ddfm=KR solution chisq ; 
REPEATED AVISITN / subject=USUBJID type=UN r rcorr ; 
LSMEANS TRTP2*AVISITN / pdiff=all cl alpha=0.05 ;  
run ; 


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