Comparison · NCT01100853-sae
VIVITROL Injection, 24 Weeks vs VIVITROL Placebo Injection, 24 Weeks: 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. VIVITROL Injection, 24 Weeks vs VIVITROL Placebo Injection, 24 Weeks: serious adverse events. Trial comparisons, record NCT01100853-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01100853-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 | 0.176 | 0.0957 | 0.303 | wilson | |
| Risk in group 2 | 0.143 | 0.071 | 0.267 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0336 | -0.114 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 0.499 | 3.06 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.438 | 3.77 | log | |
| Number needed to harm, for one more participant with a serious adverse event on VIVITROL Injection, 24 Weeks than on VIVITROL Placebo Injection, 24 Weeks | 29.7 | 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 | VIVITROL Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) | 9 | 51 | EG000 |
| Group 2 | VIVITROL Placebo Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) | 7 | 49 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
- NCT number
- NCT01100853
- Phases
- PHASE3
- Conditions
- Amphetamine Dependence
- Interventions
- VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2014-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01100853?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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