Comparison · NCT03470922-00a46afb
Arm A: Relatlimab + Nivolumab vs Arm B: Nivolumab: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation. Trial comparisons, record NCT03470922-00a46afb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03470922-00a46afb
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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 | 0.194 | 0.157 | 0.239 | wilson | |
| Risk in group 2 | 0.114 | 0.0853 | 0.151 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0802 | 0.0272 | 0.133 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.7 | 1.19 | 2.43 | log | |
| Odds ratio, group 1 over group 2 | 1.87 | 1.23 | 2.84 | log | |
| Number needed to treat, for one more participant with the outcome on Arm A: Relatlimab + Nivolumab than on Arm B: Nivolumab | 12.5 | 7.51 | 36.7 | 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: 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. | 69 | 355 | OG000 |
| 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. | 41 | 359 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
- Description
The number of participants experiencing adverse events (AEs) leading to discontinuation.~An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
- Time frame
- From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
- Population
- All treated participants
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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