Comparison · NCT01922258-sae
Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) vs Placebo (Flexible Dose Range 0.5 to 2 mg/Day): 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 (Flexible Dose Range 0.5 to 2 mg/Day) vs Placebo (Flexible Dose Range 0.5 to 2 mg/Day): serious adverse events. Trial comparisons, record NCT01922258-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01922258-sae
On this page
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 | 0.053 | 0.0259 | 0.105 | wilson | |
| Risk in group 2 | 0.0438 | 0.0202 | 0.0923 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00923 | -0.0463 | 0.0667 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.418 | 3.51 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.4 | 3.74 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) than on Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 108 | 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 | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day. | 7 | 132 | EG000 |
| Group 2 | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | Titrate up from 0.25 mg/day placebo to 1 mg/day placebo. After achieving 1 mg/day target, dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day. | 6 | 137 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through the trial: From screening to Week 12 and 30 (+2) days follow-up period.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
- NCT number
- NCT01922258
- Phases
- PHASE3
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
- Interventions
- Brexpiprazole, OPC-34712
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2020-07-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01922258?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01922258-sae