Comparison · NCT02105636-sae
Nivolumab 3mg/kg vs Investigator Choice: 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 3mg/kg vs Investigator Choice: serious adverse events. Trial comparisons, record NCT02105636-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02105636-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 | 0.699 | 0.638 | 0.754 | wilson | |
| Risk in group 2 | 0.784 | 0.698 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0846 | -0.175 | 0.0169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.892 | 0.784 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.641 | 0.377 | 1.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nivolumab 3mg/kg than on Investigator Choice | 11.8 | 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 3mg/kg | Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression | 165 | 236 | EG000 |
| Group 2 | Investigator Choice | Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice | 87 | 111 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
Source ClinicalTrials.gov
Trial
- Title
- Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
- NCT number
- NCT02105636
- Phases
- PHASE3
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Nivolumab, Cetuximab, Methotrexate, Docetaxel
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2017-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02105636?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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