Comparison · NCT03470922-sae
Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: 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: Relatlimab + Nivolumab vs Arm B: Nivolumab: serious adverse events. Trial comparisons, record NCT03470922-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03470922-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 | 0.437 | 0.386 | 0.489 | wilson | |
| Risk in group 2 | 0.39 | 0.341 | 0.441 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0466 | -0.0255 | 0.118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.94 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.9 | 1.63 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Relatlimab + Nivolumab than on Arm B: Nivolumab | 21.4 | 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 | Arm A: Relatlimab + Nivolumab | Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W).~For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg. | 155 | 355 | EG000 |
| Group 2 | Arm B: Nivolumab | Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W).~Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg. | 140 | 359 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose to up to 100 days post last dose (up to approximately 33 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
- NCT number
- NCT03470922
- Phases
- PHASE2, PHASE3
- Conditions
- Melanoma
- Interventions
- Relatlimab, Nivolumab
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2022-03-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03470922?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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