Trial Outcomes & Findings for Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (NCT NCT04103450)

NCT ID: NCT04103450

Last Updated: 2024-08-21

Results Overview

Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 \[NCT03902080\]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of \>5% has been reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 276 participants
• Primary outcome timeframe: Up to Week 52
• Results posted on: 2024-08-21

Participant Flow

A total of 276 participants who completed Study URO-901-3005 (NCT03902080) were enrolled in Study URO-901-3006 (NCT04103450) and received at least 1 dose of open-label study drug (vibegron).

Participant milestones

Measure	52-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Overall Study STARTED	142	134
Overall Study COMPLETED	126	124
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Measure	52-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Overall Study Adverse Event	4	2
Overall Study Lack of Efficacy	3	0
Overall Study Withdrawal by Subject	5	3
Overall Study Lost to Follow-up	1	2
Overall Study Physician Decision	1	2
Overall Study Protocol Violation	1	0
Overall Study Other	1	1

Baseline Characteristics

Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia

Baseline characteristics by cohort

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.	Total n=276 Participants Total of all reporting groups
Age, Continuous	67.4 Years STANDARD_DEVIATION 8.60 • n=5 Participants	67.9 Years STANDARD_DEVIATION 8.17 • n=7 Participants	67.6 Years STANDARD_DEVIATION 8.39 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	134 Participants n=7 Participants	276 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	127 Participants n=5 Participants	112 Participants n=7 Participants	239 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: SAF-Ext Population.

Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 [NCT03902080]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of >5% has been reported.

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) Any SAE	2 Participants	3 Participants
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) Any non-SAE	17 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: SAF-Ext Population.

Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC [total and differential]), and red blood cells (RBC).

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Number of Participants With Clinically Significant Changes in Hematology Parameters	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: SAF-Ext Population

Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol.

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Number of Participants With Clinically Significant Changes in Chemistry Parameters	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: SAF Ext Population.

Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Number of Participants With Clinically Significant Changes in Urinary Parameters	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: SAF Ext Population.

Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT).

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Number of Participants With Clinically Significant Changes in Coagulation Parameter	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline; Week 52

Population: SAF-Ext Population.

Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP	-1.2 Millimeters of mercury Standard Deviation 12.50	0.1 Millimeters of mercury Standard Deviation 9.31
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP	0.2 Millimeters of mercury Standard Deviation 8.79	1.1 Millimeters of mercury Standard Deviation 6.82

PRIMARY outcome

Timeframe: Baseline; Week 52

Population: SAF Ext Population.

Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=142 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 Participants Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline in Heart Rate	3.3 Beats per minute Standard Deviation 9.24	-0.7 Beats per minute Standard Deviation 7.98

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.

Micturition is defined as "Urinated in Toilet" as indicated on Bladder Diary. Micturition episodes are the number of times participants voided in the toilet as indicated on the Bladder Diary, either by marking the 'urinated in toilet' question as yes or recording non-zero volume voided. Average number of micturition episodes/day was calculated using records within the diary analysis visit divided by non-missing diary days (diary days with at least one void reported). A "Diary Day" is defined as the time between when the participants gets up for the day (ie, the time the participant got up for the day yesterday to the time participant got up for the day today; approximately a 24-hour period). The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=119 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day	-2.43 Micturition Episodes per Day Standard Error 0.299	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.

The number of urgency episodes was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Average number of daily urgency episodes at each study visit was calculated as the total number of urgency episodes using records within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=119 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day	-2.90 Urgency Episodes per Day Standard Error 0.422	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.

A nocturia episode is defined as waking to pass urine during the main sleep period as indicated on the Bladder diary. Average number of nocturia episode at each study visit was calculated as the total number of nocturia episode recorded within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=119 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night	-1.01 Nocturia Episodes per Night Standard Error 0.144	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.

The number of UUI episodes was defined as the number of times a participant checked that they had "urge" as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. The UUI was analyzed for participants with UI at Baseline. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=31 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence	-0.75 UUI Episodes per day Standard Error 0.773	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.

The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS is based on 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher scores represent greater severity of symptoms. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=127 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)	-3.5 Scores on a scale Standard Error 0.31	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.

Total volume voided was calculated using all urinary volumes collected regardless of whether participant checked "Urinated in Toilet" or not. Average volume voided per micturition at each study visit was calculated as the total volume voided recorded divided by the number of micturitions with volume recorded. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	52-Week Vibegron Group n=118 Participants Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Change From Baseline at Week 52 in the Average Volume Voided Per Micturition	20.56 Milliliters Standard Error 6.750	—

Adverse Events

52-Week Vibegron Group

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

28-Week Vibegron Group

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	52-Week Vibegron Group n=142 participants at risk Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 participants at risk Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Cardiac disorders Angina pectoris	0.70% 1/142 • Number of events 1 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	0.00% 0/134 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.
General disorders Chest pain	0.70% 1/142 • Number of events 1 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	0.00% 0/134 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.
Cardiac disorders Atrial fibrillation	0.00% 0/142 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	0.75% 1/134 • Number of events 1 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/142 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	0.75% 1/134 • Number of events 1 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.
General disorders Non-cardiac chest pain	0.00% 0/142 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	0.75% 1/134 • Number of events 1 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.

Other adverse events

Measure	52-Week Vibegron Group n=142 participants at risk Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed.	28-Week Vibegron Group n=134 participants at risk Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed.
Infections and infestations COVID-19	5.6% 8/142 • Number of events 8 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	2.2% 3/134 • Number of events 3 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.
Investigations Hypertension	6.3% 9/142 • Number of events 9 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.	0.00% 0/134 • Up to Week 52 SAEs and TEAEs were collected in Safety analysis set.

Additional Information

Information, Clinical Trial Results

Urovant Sciences

Phone: 949-226-6029

Email: info@urovant.com

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