Comparison · NCT01811940-sae
Adderall-ER and Topiramate 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
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ConductScience Library. Adderall-ER and Topiramate vs Placebo: serious adverse events. Trial comparisons, record NCT01811940-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01811940-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 | 0.0313 | 0.00861 | 0.107 | wilson | |
| Risk in group 2 | 0.0317 | 0.00875 | 0.109 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000496 | -0.0806 | 0.0786 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.984 | 0.143 | 6.77 | log | |
| Odds ratio, group 1 over group 2 | 0.984 | 0.134 | 7.21 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Adderall-ER and Topiramate than on Placebo | 2,020 | 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 | Adderall-ER and Topiramate | Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.~Adderall-ER: MAS-ER 60mg/day~Topiramate: Topiramate 100 mg bid. | 2 | 64 | EG000 |
| Group 2 | Placebo | Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.~Placebo: Placebo | 2 | 63 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- collected during 14 weeks of trial or length of participation
Source ClinicalTrials.gov
Trial
- Title
- Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
- NCT number
- NCT01811940
- Phases
- PHASE2, PHASE3
- Conditions
- Cocaine Dependence
- Interventions
- Adderall-ER, Topiramate, Placebo
- Lead sponsor
- New York State Psychiatric Institute
- Results first posted
- 2018-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01811940?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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