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Comparison · NCT02667587-deaths

Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo: deaths from any cause

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. Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo: deaths from any cause. Trial comparisons, record NCT02667587-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02667587-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7350.6870.778wilson
Risk in group 20.7120.6630.757wilson
Risk difference, group 1 minus group 20.0223-0.04310.0875newcombe hybrid score
Risk ratio, group 1 over group 21.030.9421.13log
Odds ratio, group 1 over group 21.120.8061.55log
Number needed to harm, for one more death from any cause on Radiotherapy, Temozolomide Plus Nivolumab than on Radiotherapy, Temozolomide Plus Placebo44.8from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Radiotherapy, 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
263358EG000
Group 2Radiotherapy, 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.
255358EG001

Harm

What it counts
Total, all-cause mortality
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

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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