Comparison · NCT01617447-sae
Aripiprazole 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. Aripiprazole vs Placebo: serious adverse events. Trial comparisons, record NCT01617447-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01617447-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 | 0 | 0.0756 | wilson | |
| Risk in group 2 | 0.0222 | 0.00393 | 0.116 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0222 | -0.116 | 0.0555 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Aripiprazole than on Placebo | 45 | 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 | Aripiprazole | Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8. | 0 | 47 | EG000 |
| Group 2 | Placebo | Placebo were orally administered once daily for 8 weeks. | 1 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Source ClinicalTrials.gov
Trial
- Title
- A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
- NCT number
- NCT01617447
- Phases
- PHASE3
- Conditions
- Autistic Disorder
- Interventions
- Placebo of Aripiprazole, Aripiprazole
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Results first posted
- 2017-04-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01617447?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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