Comparison · NCT03850691-sae
Cohort 1: Nivolumab vs Cohort 2: 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
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ConductScience Library. Cohort 1: Nivolumab vs Cohort 2: Nivolumab & Ipilimumab: serious adverse events. Trial comparisons, record NCT03850691-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03850691-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 | 1 | 0.207 | 1 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 1 | 0.028 | 1 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1: Nivolumab than on Cohort 2: Nivolumab & Ipilimumab | 1 | 1 | 35.8 | 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 | Cohort 1: Nivolumab | Aldesleukin: All Patients: Cycle 1:~(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.~Days 1-5 and Days 15-19 (all patients)~Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV~Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29~Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15~Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study | 1 | 1 | EG000 |
| Group 2 | Cohort 2: Nivolumab & Ipilimumab | Aldesleukin: All Patients: Cycle 1:~(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.~Days 1-5 and Days 15-19 (all patients)~Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29~OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:~Nivolumab 1 mg/kg IV on Day 29~Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29~Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29.~Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study~Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29~OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:~Ipilimumab 3 mg/kg IV on Day 29~Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29~Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29 | 0 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.
Source ClinicalTrials.gov
Trial
- Title
- Radiation and Combination Immunotherapy for Melanoma
- NCT number
- NCT03850691
- Phases
- PHASE2
- Conditions
- Metastatic Melanoma
- Interventions
- Aldesleukin: All Patients, Nivolumab: Cohort 1 (Cutaneous), Nivolumab: Cohort 2 (Ocular), Ipilimumab: Cohort 2 (Ocular)
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Results first posted
- 2023-03-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03850691?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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