Comparison · NCT03635983-sae
Bempegaldesleukin + 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
Cite this record
ConductScience Library. Bempegaldesleukin + Nivolumab vs Nivolumab: serious adverse events. Trial comparisons, record NCT03635983-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03635983-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 | 0.415 | 0.367 | 0.465 | wilson | |
| Risk in group 2 | 0.45 | 0.401 | 0.5 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0353 | -0.105 | 0.0345 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.922 | 0.784 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.866 | 0.651 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Bempegaldesleukin + Nivolumab than on Nivolumab | 28.3 | 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 | Bempegaldesleukin + Nivolumab | Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks | 161 | 388 | EG000 |
| Group 2 | Nivolumab | Nivolumab 360 mg IV every 3 weeks | 172 | 382 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months).
Source ClinicalTrials.gov
Trial
- Title
- A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
- NCT number
- NCT03635983
- Phases
- PHASE3
- Conditions
- Melanoma
- Interventions
- NKTR-214, Nivolumab
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2022-12-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03635983?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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