Comparison · NCT03806127-5e5173c0
Vibegron 75 mg vs Placebo: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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: Number of Participants With Any Treatment-emergent Adverse Event (TEAE). Trial comparisons, record NCT03806127-5e5173c0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03806127-5e5173c0
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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 | 0.333 | 0.253 | 0.425 | wilson | |
| Risk in group 2 | 0.333 | 0.253 | 0.425 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.122 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.689 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.572 | 1.75 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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). | 37 | 111 | OG001 |
| 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 \[IBS-M\]). | 37 | 111 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- Description
- TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.
- 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 Day 113 or Early Withdrawal plus 28 days)
- Population
Safety Analysis Set: all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
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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