Comparison · NCT03583372-sae
Overall Vibegron 75 mg vs Overall Tolterodine ER 4 mg: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Overall Vibegron 75 mg vs Overall Tolterodine ER 4 mg: serious adverse events. Trial comparisons, record NCT03583372-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03583372-sae
On this page
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 | 0.033 | 0.0174 | 0.0615 | wilson | |
| Risk in group 2 | 0.0431 | 0.0236 | 0.0775 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0101 | -0.0479 | 0.0244 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.765 | 0.316 | 1.85 | log | |
| Odds ratio, group 1 over group 2 | 0.757 | 0.302 | 1.9 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Overall Vibegron 75 mg than on Overall Tolterodine ER 4 mg | 98.7 | 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 | Overall Vibegron 75 mg | Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | 9 | 273 | EG000 |
| Group 2 | Overall Tolterodine ER 4 mg | Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | 10 | 232 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 56 weeks
Source ClinicalTrials.gov
Trial
- Title
- An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
- NCT number
- NCT03583372
- Phases
- PHASE3
- Conditions
- Overactive Bladder
- Interventions
- Vibegron, placebos, Tolterodine Tartrate ER
- Lead sponsor
- Urovant Sciences GmbH
- Results first posted
- 2021-02-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03583372?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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