Comparison · NCT03729245-sae
Combination of Bempegaldesleukin + Nivolumab vs Sunitinib or Cabozantinib: 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. Combination of Bempegaldesleukin + Nivolumab vs Sunitinib or Cabozantinib: serious adverse events. Trial comparisons, record NCT03729245-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03729245-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 | 0.365 | 0.313 | 0.419 | wilson | |
| Risk in group 2 | 0.297 | 0.249 | 0.351 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0671 | -0.00719 | 0.14 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 0.977 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 1.36 | 0.967 | 1.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Combination of Bempegaldesleukin + Nivolumab than on Sunitinib or Cabozantinib | 14.9 | 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 | Combination of Bempegaldesleukin + Nivolumab | Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.~Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w | 113 | 310 | EG000 |
| Group 2 | Sunitinib or Cabozantinib | Patients in Arm B will receive the Investigator's choice of either one of two treatment options.~Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily | 91 | 306 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s), up to 38 months. All ongoing non-serious AEs will be followed until resolution, the patient is lost to follow-up, patient death, or until the last Safety Follow-Up Visit. If the AE has not completely resolved by the last Safety Follow-Up Visit, the final outcome of these ongoing AEs will be captured.
Source ClinicalTrials.gov
Trial
- Title
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
- NCT number
- NCT03729245
- Phases
- PHASE3
- Conditions
- Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Interventions
- bempegaldesleukin, sunitinib, nivolumab, cabozantinib
- Lead sponsor
- Nektar Therapeutics
- Results first posted
- 2023-04-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03729245?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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