Comparison · NCT01838681-sae
Placebo and ADT vs Brexpiprazole and ADT: 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. Placebo and ADT vs Brexpiprazole and ADT: serious adverse events. Trial comparisons, record NCT01838681-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01838681-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 | 0.0295 | 0.0173 | 0.0498 | wilson | |
| Risk in group 2 | 0.0203 | 0.0107 | 0.0381 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00921 | -0.0124 | 0.0316 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.45 | 0.628 | 3.37 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.621 | 3.47 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo and ADT than on Brexpiprazole and ADT | 109 | 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 | Placebo and ADT | Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally | 13 | 441 | EG000 |
| Group 2 | Brexpiprazole and ADT | Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, 3, mg/day, once daily, tablets, orally | 9 | 444 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomisation to end of study (28 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
- NCT number
- NCT01838681
- Phases
- PHASE3
- Conditions
- Major Depressive Disorder
- Interventions
- Placebo, Brexpiprazole, ADT
- Lead sponsor
- H. Lundbeck A/S
- Results first posted
- 2017-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01838681?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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