Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH) (NCT NCT03902080)
NCT ID: NCT03902080
Last Updated: 2024-08-07
Results Overview
Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1105 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2024-08-07
Participant Flow
This was a Phase 3, randomized, double-blind, placebo-controlled, 2 part, parallel-group, multicenter study to evaluate the safety, tolerability, and efficacy of vibegron in men with symptoms of overactive bladder (OAB) on stable doses of pharmacological therapy for benign prostatic hyperplasia (BPH).
Participants were enrolled in 82 sites across 8 countries. One randomized participant enrolled in the placebo group did not receive double-blind medication.
Participant milestones
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Overall Study
STARTED
|
551
|
554
|
|
Overall Study
Received at Least 1 Dose of Double-blind Medication
|
551
|
553
|
|
Overall Study
COMPLETED
|
484
|
481
|
|
Overall Study
NOT COMPLETED
|
67
|
73
|
Reasons for withdrawal
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
15
|
|
Overall Study
Withdrawal by Subject
|
28
|
35
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
|
Overall Study
Other
|
3
|
5
|
|
Overall Study
Non compliance
|
4
|
3
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Withdrawn prior to dosing
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
Baseline characteristics by cohort
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=538 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=542 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
Total
n=1080 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 8.06 • n=93 Participants
|
67.4 years
STANDARD_DEVIATION 7.92 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 7.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
538 Participants
n=93 Participants
|
542 Participants
n=4 Participants
|
1080 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
471 Participants
n=93 Participants
|
475 Participants
n=4 Participants
|
946 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only those participants with data available at specified time points have been presented.
Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Outcome measures
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=503 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=507 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day
|
-2.04 Micturitions per day
Standard Error 0.109
|
-1.30 Micturitions per day
Standard Error 0.109
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only those participants with data available at specified time points have been presented.
Urgency was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Outcome measures
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=503 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=507 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day
|
-2.88 Urgency Episodes per Day
Standard Error 0.164
|
-1.93 Urgency Episodes per Day
Standard Error 0.164
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only those participants with data available at specified time points have been presented.
Nocturia was defined as waking to pass urine during the main sleep period. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value.
Outcome measures
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=503 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=507 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night
|
-0.88 Nocturia episodes per night
Standard Error 0.054
|
-0.66 Nocturia episodes per night
Standard Error 0.054
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set for Incontinence (FAS-I) consists of all randomized participants with incontinence at baseline who took at least one dose of double-blind study medication, have an evaluable baseline urgency urinary incontinence measurement, and have at least one evaluable change from baseline urgency urinary incontinence measurement. Only those participants with data available at specified time points have been presented.
The number of UUI episodes was defined as the number of times a subject 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. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Outcome measures
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=136 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=140 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline
|
-2.19 UUI Episodes Per Day
Standard Error 0.210
|
-1.39 UUI Episodes Per Day
Standard Error 0.202
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only those participants with data available at specified time points have been presented.
The IPSS is based on the responses to 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 particular symptom. The responses are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher numerical scores represent greater severity of symptoms. Decrease in IPSS storage score indicates improvement. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value.
Outcome measures
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=499 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=495 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
|
-3.0 Scores on a scale
Standard Error 0.13
|
-2.2 Scores on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only those participants with data available at specified time points have been presented.
Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Average volume voided per micturition at each study visit was calculated as the total volume voided over diary days within the analysis visit window divided by the total number of micturition episodes during non-missing diary days.
Outcome measures
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=503 Participants
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=506 Participants
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Change From Baseline at Week 12 in the Average Volume Voided Per Micturition
|
25.63 mL
Standard Error 2.328
|
10.56 mL
Standard Error 2.330
|
Adverse Events
Vibegron 75 Milligrams (mg) Once Daily (QD)
Serious events: 24 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=553 participants at risk
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=551 participants at risk
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Infections and infestations
Device related infection
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.36%
2/551 • Number of events 2 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
Bullous erysipelas
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Cardiac disorders
Cardiac failure
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Psychiatric disorders
Depression
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Product Issues
Device lead issue
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Nervous system disorders
Monoplegia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Nervous system disorders
Nervous system disorder
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
Pneumonia
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
Post procedural infection
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Nervous system disorders
Syncope
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Skin and subcutaneous tissue disorders
Urticarial vasculitis
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.18%
1/553 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.00%
0/551 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
COVID-19
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.36%
2/551 • Number of events 2 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Vascular disorders
Hypertension
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/553 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
0.18%
1/551 • Number of events 1 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
Other adverse events
| Measure |
Vibegron 75 Milligrams (mg) Once Daily (QD)
n=553 participants at risk
Participants were randomized 1:1 to receive 75 mg of Vibegron tablet orally QD
|
Placebo
n=551 participants at risk
Participants were randomized 1:1 to receive matching placebo tablet orally QD
|
|---|---|---|
|
Infections and infestations
COVID-19
|
4.0%
22/553 • Number of events 22 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
3.1%
17/551 • Number of events 17 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
14/553 • Number of events 15 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
2.2%
12/551 • Number of events 13 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Vascular disorders
Hypertension
|
9.0%
50/553 • Number of events 53 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
8.3%
46/551 • Number of events 46 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
11/553 • Number of events 11 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
2.5%
14/551 • Number of events 15 • Up to Week 24
The Safety Analysis (SAS) Set includes all randomized subjects who received at least one dose of double-blind study treatment. Subjects who took any dose of Vibegron are classified as Vibegron subjects, while those who only took placebo are classified as placebo subjects. Two subjects initially randomized to placebo received Vibegron. Treatment-emergent AEs are those starting on or after the first dose of the blinded study drug, and all AE summaries cover treatment-emergent AEs in the SAS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place