Comparison · NCT03068455-sae
Arm A: Nivo + Ipi vs Arm B: Nivo: 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. Arm A: Nivo + Ipi vs Arm B: Nivo: serious adverse events. Trial comparisons, record NCT03068455-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03068455-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 | 0.408 | 0.377 | 0.44 | wilson | |
| Risk in group 2 | 0.264 | 0.236 | 0.293 | wilson | |
| Risk difference, group 1 minus group 2 | 0.144 | 0.101 | 0.187 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.55 | 1.35 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 1.92 | 1.58 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Nivo + Ipi than on Arm B: Nivo | 6.93 | 5.36 | 9.87 | 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 | Arm A: Nivo + Ipi | Arm A: nivolumab 240 mg IV Q2 weeks plus ipilimumab 1 mg/kg IV Q6 weeks (for 1 year of study drug treatment) | 374 | 916 | EG000 |
| Group 2 | Arm B: Nivo | Arm B: nivolumab 480 mg IV Q4 weeks (for 1 year of study drug treatment) with nivolumab placebo on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, \& 47 and ipilimumab placebo on Weeks 1, 7, 13, 19, 25, 31, 37, 43, \& 49 | 242 | 917 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from first dose to study completion date (up to approximately 45 months). Serious Adverse Events and Non Serious Adverse Events above 5% were assessed from first dose to 100 days post last dose (up to approximately 15 months)
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
- NCT number
- NCT03068455
- Phases
- PHASE3
- Conditions
- Melanoma
- Interventions
- nivolumab, ipilimumab
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2021-07-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03068455?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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