Comparison · NCT02231749-sae
Nivolumab + Ipilimumab vs Sunitinib: 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. Nivolumab + Ipilimumab vs Sunitinib: serious adverse events. Trial comparisons, record NCT02231749-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02231749-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 | 0.558 | 0.516 | 0.599 | wilson | |
| Risk in group 2 | 0.398 | 0.358 | 0.44 | wilson | |
| Risk difference, group 1 minus group 2 | 0.159 | 0.1 | 0.217 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 1.23 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 1.5 | 2.43 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nivolumab + Ipilimumab than on Sunitinib | 6.27 | 4.6 | 9.99 | 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 | Nivolumab + Ipilimumab | Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | 305 | 547 | EG000 |
| Group 2 | Sunitinib | Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks | 213 | 535 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
Source ClinicalTrials.gov
Trial
- Title
- Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
- NCT number
- NCT02231749
- Phases
- PHASE3
- Conditions
- Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Interventions
- Nivolumab, Ipilimumab, Sunitinib
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2018-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02231749?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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