Comparison · NCT04103450-sae
52-Week Vibegron Group vs 28-Week Vibegron Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 52-Week Vibegron Group vs 28-Week Vibegron Group: serious adverse events. Trial comparisons, record NCT04103450-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04103450-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0141 | 0.00387 | 0.0499 | wilson | |
| Risk in group 2 | 0.0224 | 0.00764 | 0.0638 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0083 | -0.0509 | 0.0304 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.629 | 0.107 | 3.71 | log | |
| Odds ratio, group 1 over group 2 | 0.624 | 0.103 | 3.79 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 52-Week Vibegron Group than on 28-Week Vibegron Group | 120 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 2 | 142 | EG000 |
| Group 2 | 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. | 3 | 134 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 52
Source ClinicalTrials.gov
Trial
- Title
- Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
- NCT number
- NCT04103450
- Phases
- PHASE3
- Conditions
- Overactive Bladder
- Interventions
- Vibegron
- Lead sponsor
- Urovant Sciences GmbH
- Results first posted
- 2024-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04103450?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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