Comparison · NCT04258839-sae
Prior Brexpiprazole vs Prior 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. Prior Brexpiprazole vs Prior Placebo: serious adverse events. Trial comparisons, record NCT04258839-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04258839-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 | 0.0408 | 0.0113 | 0.137 | wilson | |
| Risk in group 2 | 0.0217 | 0.00385 | 0.113 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0191 | -0.0772 | 0.117 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.88 | 0.176 | 20 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 0.168 | 21.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Prior Brexpiprazole than on Prior Placebo | 52.4 | 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 | Prior Brexpiprazole | Participants who received brexpiprazole in the parent study 331-201-00148 (NCT04174365) received brexpiprazole based on the body weight for 26 weeks in this study.~Participants with body weight \< 50 kg, received brexpiprazole tablets orally, QD at dose of 0.25 mg on Days 1 to 3 followed by 0.5 mg on Days 4 to 7 and 1 mg on Days 8 to 14. Based on the investigator's judgment, the dose was increased to 1 or 1.5 mg starting from Day 15 until week 26.~Participants with body weight ≥ 50 kg received brexpiprazole tablet orally, QD at dose of 0.5 mg on Days 1 to 3, followed by 1.5 mg on Days 4 to 7, and 2 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 1.5, 2, or 3 mg starting from Day 15 until week 26. | 2 | 49 | EG000 |
| Group 2 | Prior Placebo | Participants who received placebo matched to brexpiprazole in the parent study 331-201-00148 (NCT04174365) received brexpiprazole based on the body weight for 26 weeks in this study.~Participants with body weight \< 50 kg, received brexpiprazole tablets orally, QD at dose of 0.25 mg on Days 1 to 3 followed by 0.5 mg on Days 4 to 7 and 1 mg on Days 8 to 14. Based on the investigator's judgment, the dose was increased to 1 or 1.5 mg starting from Day 15 until week 26.~Participants with body weight ≥ 50 kg received brexpiprazole tablet orally, QD at dose of 0.5 mg on Days 1 to 3, followed by 1.5 mg on Days 4 to 7, and to 2 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 1.5, 2 or 3 mg starting from Day 15 until week 26. | 1 | 46 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose of study drug (in current study) up to 21 days after the last dose of study drug (up to approximately 29 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
- NCT number
- NCT04258839
- Phases
- PHASE3
- Conditions
- Irritability Associated With Autism Spectrum Disorder
- Interventions
- Brexpiprazole
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2024-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04258839?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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