Comparison · NCT03095066-sae
All AVP-786 vs All 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. All AVP-786 vs All Placebo: serious adverse events. Trial comparisons, record NCT03095066-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03095066-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 | 0.0261 | 0.00891 | 0.0739 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000347 | 0.0442 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0261 | -0.0214 | 0.0739 | 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 harm, for one more participant with a serious adverse event on All AVP-786 than on All Placebo | 38.3 | 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 | All AVP-786 | Participants who were randomized to receive AVP-768 throughout the study and participants who were randomized to receive placebo in Stage 1 and were then re-randomized after Week 6 to receive AVP-786 in Stage 2.~Participants received AVP-786-28/4.9 capsule along with AVP-786 matching placebo capsule, orally, QD for 1 week, followed by AVP-786-28/4.9 capsule, orally, BID, for the next one week and AVP-786-42.63/4.9 capsules (target dose), orally, BID during the rest of the treatment period. | 3 | 115 | EG001 |
| Group 2 | All Placebo | Participants received AVP-786 matching placebo capsules, orally, BID, during Stage 1 or Stage 2 of the study treatment. | 0 | 83 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study up to 7 days after the last dose of study drug (up to 13 weeks)
Source ClinicalTrials.gov
Trial
- Title
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
- NCT number
- NCT03095066
- Phases
- PHASE2
- Conditions
- Neurobehavioral Disinhibition
- Interventions
- Placebo, AVP-786-28, AVP-786-42.63
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2025-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03095066?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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