Comparison · NCT03806127-sae
Vibegron 75 mg vs Placebo: 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. Vibegron 75 mg vs Placebo: serious adverse events. Trial comparisons, record NCT03806127-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03806127-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 | 0.018 | 0.00496 | 0.0633 | wilson | |
| Risk in group 2 | 0.00901 | 0.00159 | 0.0493 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00901 | -0.0333 | 0.0549 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.184 | 21.7 | log | |
| Odds ratio, group 1 over group 2 | 2.02 | 0.18 | 22.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vibegron 75 mg than on Placebo | 111 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M). | 2 | 111 | EG001 |
| Group 2 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]). | 1 | 111 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
- NCT number
- NCT03806127
- Phases
- PHASE2
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Vibegron, Placebo
- Lead sponsor
- Urovant Sciences GmbH
- Results first posted
- 2021-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03806127?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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