Comparison · NCT02741570-sae
Nivolumab + Ipilimumab vs EXTREME Regimen: 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. Nivolumab + Ipilimumab vs EXTREME Regimen: serious adverse events. Trial comparisons, record NCT02741570-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02741570-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 | 0.669 | 0.625 | 0.71 | wilson | |
| Risk in group 2 | 0.658 | 0.612 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0112 | -0.05 | 0.0725 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.927 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.798 | 1.38 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nivolumab + Ipilimumab than on EXTREME Regimen | 89.2 | 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 | Nivolumab + Ipilimumab | Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment. | 313 | 468 | EG000 |
| Group 2 | EXTREME Regimen | Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator. | 290 | 441 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)
Source ClinicalTrials.gov
Trial
- Title
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- NCT number
- NCT02741570
- Phases
- PHASE3
- Conditions
- Head and Neck Cancer
- Interventions
- Nivolumab, Ipilimumab, Cetuximab/Erbitux, Cisplatin/Platinol, Carboplatin/Paraplatin, Fluorouracil/Adrucil
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2022-05-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02741570?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
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT02741570-sae