Comparison · NCT01641159-sae
Buspirone Plus TAU vs Placebo Plus TAU: 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. Buspirone Plus TAU vs Placebo Plus TAU: serious adverse events. Trial comparisons, record NCT01641159-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01641159-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 | 0.0857 | 0.0296 | 0.224 | wilson | |
| Risk in group 2 | 0 | 0 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0857 | -0.0509 | 0.224 | 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 Buspirone Plus TAU than on Placebo Plus TAU | 11.7 | 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 | Buspirone Plus TAU | Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated. | 3 | 35 | EG000 |
| Group 2 | Placebo Plus TAU | Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets. | 0 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence
- NCT number
- NCT01641159
- Phases
- PHASE2
- Conditions
- Cocaine Dependence
- Interventions
- Buspirone, Placebo
- Lead sponsor
- University of Cincinnati
- Results first posted
- 2014-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01641159?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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