Comparison · NCT03937219-sae
Cabozantinib + Nivolumab + Ipilimumab vs Placebo + Nivolumab + 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. Cabozantinib + Nivolumab + Ipilimumab vs Placebo + Nivolumab + Ipilimumab: serious adverse events. Trial comparisons, record NCT03937219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03937219-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 | 0.638 | 0.592 | 0.683 | wilson | |
| Risk in group 2 | 0.608 | 0.56 | 0.653 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0309 | -0.0342 | 0.0957 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.946 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.864 | 1.51 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cabozantinib + Nivolumab + Ipilimumab than on Placebo + Nivolumab + Ipilimumab | 32.3 | 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 | Cabozantinib + Nivolumab + Ipilimumab | Participants received cabozantinib 40 mg orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion q4w. | 272 | 426 | EG000 |
| Group 2 | Placebo + Nivolumab + Ipilimumab | Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w. | 257 | 423 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to 58 months
Source ClinicalTrials.gov
Trial
- Title
- Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
- NCT number
- NCT03937219
- Phases
- PHASE3
- Conditions
- Renal Cell Carcinoma
- Interventions
- Cabozantinib, Nivolumab, Ipilimumab, Cabozantinib-matched placebo
- Lead sponsor
- Exelixis
- Results first posted
- 2025-09-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03937219?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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