Comparison · NCT02667587-sae
Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo: 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. Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo: serious adverse events. Trial comparisons, record NCT02667587-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02667587-sae
On this page
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 | 0.73 | 0.681 | 0.773 | wilson | |
| Risk in group 2 | 0.613 | 0.561 | 0.662 | wilson | |
| Risk difference, group 1 minus group 2 | 0.117 | 0.0475 | 0.184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 1.07 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 1.7 | 1.24 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Radiotherapy, Temozolomide Plus Nivolumab than on Radiotherapy, Temozolomide Plus Placebo | 8.58 | 5.43 | 21.1 | 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 | Radiotherapy, Temozolomide Plus Nivolumab | Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks | 259 | 355 | EG000 |
| Group 2 | Radiotherapy, Temozolomide Plus Placebo | Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles. | 217 | 354 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
- NCT number
- NCT02667587
- Phases
- PHASE3
- Conditions
- Brain Neoplasms
- Interventions
- Nivolumab, Temozolomide, Radiotherapy, Nivolumab Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2022-02-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02667587?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.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02667587-sae