Comparison · NCT04410445-sae
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab vs 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
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ConductScience Library. Combination of Bempegaldesleukin (NKTR-214) + Nivolumab vs Nivolumab: serious adverse events. Trial comparisons, record NCT04410445-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04410445-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 | 0.196 | 0.159 | 0.239 | wilson | |
| Risk in group 2 | 0.0853 | 0.0614 | 0.117 | wilson | |
| Risk difference, group 1 minus group 2 | 0.11 | 0.0616 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.3 | 1.56 | 3.37 | log | |
| Odds ratio, group 1 over group 2 | 2.61 | 1.69 | 4.05 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Combination of Bempegaldesleukin (NKTR-214) + Nivolumab than on Nivolumab | 9.05 | 6.26 | 16.2 | 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 | Combination of Bempegaldesleukin (NKTR-214) + Nivolumab | Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.~Bempegaldesleukin: Specified dose on specified days~Nivolumab: Specified dose on specified days | 74 | 378 | EG000 |
| Group 2 | Nivolumab | Arm B: Participants will receive nivolumab IV alone every 4 weeks.~Nivolumab: Specified dose on specified days | 33 | 387 | 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 a maximum of approximately 21 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
- Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
- NCT number
- NCT04410445
- Phases
- PHASE3
- Conditions
- Melanoma, Melanoma Stage III, Melanoma Stage IV, Melanoma (Skin)
- Interventions
- Bempegaldesleukin, Nivolumab
- Lead sponsor
- Nektar Therapeutics
- Results first posted
- 2023-04-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04410445?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT04410445-sae