Comparison · NCT02617589-sae
Nivolumab + Radiation Therapy vs Temozolomide + Radiation Therapy: 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 + Radiation Therapy vs Temozolomide + Radiation Therapy: serious adverse events. Trial comparisons, record NCT02617589-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02617589-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 | 0.741 | 0.686 | 0.789 | wilson | |
| Risk in group 2 | 0.513 | 0.454 | 0.571 | wilson | |
| Risk difference, group 1 minus group 2 | 0.228 | 0.148 | 0.304 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.45 | 1.26 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 2.72 | 1.9 | 3.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nivolumab + Radiation Therapy than on Temozolomide + Radiation Therapy | 4.38 | 3.29 | 6.74 | 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 | Nivolumab + Radiation Therapy | Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously | 206 | 278 | EG000 |
| Group 2 | Temozolomide + Radiation Therapy | Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally | 141 | 275 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
- NCT number
- NCT02617589
- Phases
- PHASE3
- Conditions
- Brain Cancer
- Interventions
- Nivolumab, Temozolomide, Radiotherapy
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2021-02-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02617589?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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