Comparison · NCT01515189-sae
10 MG/KG IPILIMUMAB vs 3 MG/KG IPILIMUMAB: 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. 10 MG/KG IPILIMUMAB vs 3 MG/KG IPILIMUMAB: serious adverse events. Trial comparisons, record NCT01515189-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01515189-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 | 0.673 | 0.623 | 0.719 | wilson | |
| Risk in group 2 | 0.536 | 0.484 | 0.587 | wilson | |
| Risk difference, group 1 minus group 2 | 0.137 | 0.0661 | 0.206 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 1.11 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 1.78 | 1.32 | 2.41 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 10 MG/KG IPILIMUMAB than on 3 MG/KG IPILIMUMAB | 7.29 | 4.85 | 15.1 | from the risk difference interval |
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 | 10 MG/KG IPILIMUMAB | 245 | 364 | EG000 | |
| Group 2 | 3 MG/KG IPILIMUMAB | 194 | 362 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 1 of study treatment until 90 days following last day of study treatment, up to study completion (August 2017)
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
- NCT number
- NCT01515189
- Phases
- PHASE3
- Conditions
- Melanoma
- Interventions
- Ipilimumab
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2017-03-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01515189?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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