Comparison · NCT05401565-cb84325a
Balovaptan vs Placebo: Percentage of Participants With 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. Balovaptan vs Placebo: Percentage of Participants With Adverse Events. Trial comparisons, record NCT05401565-cb84325a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05401565-cb84325a
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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 | 0.692 | 0.424 | 0.873 | wilson | |
| Risk in group 2 | 0.438 | 0.231 | 0.668 | wilson | |
| Risk difference, group 1 minus group 2 | 0.255 | -0.0993 | 0.529 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.58 | 0.815 | 3.07 | log | |
| Odds ratio, group 1 over group 2 | 2.89 | 0.622 | 13.5 | log | |
| Number needed to treat, for one more participant with the outcome on Balovaptan than on Placebo | 3.92 | 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 | Balovaptan | Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period | 9 | 13 | OG001 |
| Group 2 | Placebo | Matching placebo | 7 | 16 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With Adverse Events
- Description
- Time frame
- From Baseline up to Week 12
- Population
- Safety Population
Source ClinicalTrials.gov
Trial
- Title
- Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
- NCT number
- NCT05401565
- Phases
- PHASE2
- Conditions
- Stress Disorders, Post-Traumatic
- Interventions
- Balovaptan, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05401565?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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