Trial Outcomes & Findings for An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB). (NCT NCT03583372)

Last Updated: 2021-03-18

Results Overview

Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

506 participants

Primary outcome timeframe

up to 56 weeks

Results posted on

2021-03-18

Participant Flow

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

Participant milestones

Participant milestones
Measure	40 Weeks Vibegron 75 mg Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	52 Weeks Vibegron 75 mg Participants who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	40 Weeks Tolterodine ER 4 mg Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	52 Weeks Tolterodine ER 4 mg Participants who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
Overall Study STARTED	92	182	91	141
Overall Study COMPLETED	79	156	72	123
Overall Study NOT COMPLETED	13	26	19	18

Reasons for withdrawal

Reasons for withdrawal
Measure	40 Weeks Vibegron 75 mg Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	52 Weeks Vibegron 75 mg Participants who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	40 Weeks Tolterodine ER 4 mg Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	52 Weeks Tolterodine ER 4 mg Participants who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
Overall Study Withdrawal by Subject	6	11	7	8
Overall Study Lost to Follow-up	4	6	3	2
Overall Study Adverse Event	1	3	4	4
Overall Study Physician Decision	0	1	1	1
Overall Study Lack of Efficacy	0	1	0	1
Overall Study Death	1	0	0	0
Overall Study Protocol Violation	0	1	0	0
Overall Study Subject Withdrawn due to Sponsor	0	0	0	1
Overall Study Did Not Receive Study Drug	0	1	0	0
Overall Study Captured as Other in the Database	1	2	4	1

Baseline Characteristics

An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	40 Weeks Vibegron 75 mg n=92 Participants Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	52 Weeks Vibegron 75 mg n=181 Participants Participants who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	40 Weeks Tolterodine ER 4 mg n=91 Participants Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	52 Weeks Tolterodine ER 4 mg n=141 Participants Participants who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Total n=505 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 13.69 • n=5 Participants	62.1 years STANDARD_DEVIATION 12.39 • n=7 Participants	62.1 years STANDARD_DEVIATION 12.14 • n=5 Participants	60.6 years STANDARD_DEVIATION 12.98 • n=4 Participants	61.1 years STANDARD_DEVIATION 12.78 • n=21 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	140 Participants n=7 Participants	70 Participants n=5 Participants	112 Participants n=4 Participants	395 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	41 Participants n=7 Participants	21 Participants n=5 Participants	29 Participants n=4 Participants	110 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	39 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants	23 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants	73 Participants n=21 Participants
Race/Ethnicity, Customized White	72 Participants n=5 Participants	141 Participants n=7 Participants	72 Participants n=5 Participants	102 Participants n=4 Participants	387 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Overactive Bladder (OAB) Type Wet	71 Participants n=5 Participants	146 Participants n=7 Participants	70 Participants n=5 Participants	108 Participants n=4 Participants	395 Participants n=21 Participants
Overactive Bladder (OAB) Type Dry	21 Participants n=5 Participants	35 Participants n=7 Participants	21 Participants n=5 Participants	33 Participants n=4 Participants	110 Participants n=21 Participants

PRIMARY outcome

Timeframe: up to 56 weeks

Population: Safety Extension Set (SAF-Ext) Population: all participants who received at least 1 dose of double-blind study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Adverse event datasets for Study RVT-901-3003 and Study RVT-901-3004 were combined for the safety analyses.

Outcome measures

Outcome measures
Measure	Overall Vibegron 75 mg n=273 Participants Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=232 Participants Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any TEAE	171 participants	126 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any study drug-related TEAE	59 participants	46 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any Grade ≥ 3 TEAE	10 participants	8 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any Grade ≥ 3 study drug-related TEAE	1 participants	1 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any treatment-emergent (TE) SAE	9 participants	10 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any study drug-related TE SAE	1 participants	2 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any TEAE leading to discontinuation of study drug	4 participants	8 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any TEAE of clinical interest	41 participants	32 participants
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event Any study drug-related TEAE of clinical interest	14 participants	10 participants

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) Population: all randomized OAB participants who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study. Only participants with evaluable data were analyzed.

A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.

Outcome measures

Outcome measures
Measure	Overall Vibegron 75 mg n=152 Participants Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=120 Participants Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants	-2.4 micturitions per 24 hours Standard Error 0.24	-2.0 micturitions per 24 hours Standard Error 0.26

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension for Incontinence (FAS-Ext-I) Population: all randomized OAB Wet participants who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.

The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed.

Outcome measures

Outcome measures
Measure	Overall Vibegron 75 mg n=125 Participants Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=91 Participants Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants	-2.2 UUI episodes per 24 hours Standard Error 0.15	-1.7 UUI episodes per 24 hours Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: FAS-Ext Population. Only participants with evaluable data were analyzed.

The number of urgency episodes is defined as the number of times a participant had checked "need to urinate immediately" on a CDD divided by the number of CDDs in the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.

Outcome measures

Outcome measures
Measure	Overall Vibegron 75 mg n=152 Participants Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=120 Participants Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants	-3.4 urgency episodes over 24 hours Standard Error 0.34	-3.2 urgency episodes over 24 hours Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: FAS-Ext-I Population. Only participants with evaluable data were analyzed.

The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of "urge," "stress," or "other." CFB was calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour.

Outcome measures

Outcome measures
Measure	Overall Vibegron 75 mg n=125 Participants Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=91 Participants Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants	-2.5 Urinary incontinence episodes over 24 hr Standard Error 0.17	-1.9 Urinary incontinence episodes over 24 hr Standard Error 0.19

Adverse Events

Overall Vibegron 75 mg

Serious events: 9 serious events

Other events: 65 other events

Deaths: 1 deaths

Overall Tolterodine ER 4 mg

Serious events: 10 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Overall Vibegron 75 mg n=273 participants at risk Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=232 participants at risk Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
Gastrointestinal disorders Dry mouth	1.8% 5/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	5.2% 12/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Infections and infestations Nasopharyngitis	4.8% 13/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	5.2% 12/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Infections and infestations Urinary tract infection	6.6% 18/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	7.3% 17/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Nervous system disorders Headache	5.5% 15/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	3.9% 9/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Vascular disorders Hypertension	8.8% 24/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	8.6% 20/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.

Additional Information

Information, Clinical Trial Results

Urovant Sciences

Phone: 949-226-6029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.
Publication restrictions are in place

Restriction type: OTHER

Measure	Overall Vibegron 75 mg n=273 participants at risk Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.	Overall Tolterodine ER 4 mg n=232 participants at risk Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
Gastrointestinal disorders Colitis	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Gastrointestinal disorders Colitis microscopic	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Infections and infestations Appendicitis	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Infections and infestations Urosepsis	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Cardiac disorders Angina unstable	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Cardiac disorders Cardiac failure	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Cardiac disorders Cardiomyopathy	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
General disorders Chest pain	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Vascular disorders Aortic stenosis	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Vascular disorders Arteriosclerosis	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Ear and labyrinth disorders Vertigo positional	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Injury, poisoning and procedural complications Pelvic fracture	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.37% 1/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.00% 0/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Nervous system disorders Syncope	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Psychiatric disorders Depression	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Renal and urinary disorders Ureterolithiasis	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/273 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.	0.43% 1/232 • up to 56 weeks Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all participants who received at least one dose of double-blind study treatment during RVT-901-3004. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.