Comparison · NCT04124614-sae
Brexpiprazole + Sertraline vs Sertraline + 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. Brexpiprazole + Sertraline vs Sertraline + Placebo: serious adverse events. Trial comparisons, record NCT04124614-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04124614-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 | 0.00488 | 0.000862 | 0.0271 | wilson | |
| Risk in group 2 | 0.0204 | 0.00796 | 0.0513 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0155 | -0.0467 | 0.00995 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.239 | 0.027 | 2.12 | log | |
| Odds ratio, group 1 over group 2 | 0.235 | 0.0261 | 2.12 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Brexpiprazole + Sertraline than on Sertraline + Placebo | 64.4 | 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 | Brexpiprazole + Sertraline | Randomized participants received brexpiprazole as a flexible dose 2 mg to 3 mg, orally, QD along with sertraline, at a fixed dose of 150 mg, orally, QD from Week 1 to Week 12 of the DBT period. | 1 | 205 | EG000 |
| Group 2 | Sertraline + Placebo | Randomized participants received sertraline, 150 mg, orally, QD along with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period. | 4 | 196 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose of the study drug up to 21 days after the last dose (Up to Week 15)
Source ClinicalTrials.gov
Trial
- Title
- Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
- NCT number
- NCT04124614
- Phases
- PHASE3
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Brexpiprazole, Sertraline, Placebo
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2025-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04124614?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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