Comparison · NCT03718767-sae
Cohort 1/Hypermutated Phenotype (HMP) vs Cohort 2/Non-hypermutated Phenotype (NHMP).: 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. Cohort 1/Hypermutated Phenotype (HMP) vs Cohort 2/Non-hypermutated Phenotype (NHMP).: serious adverse events. Trial comparisons, record NCT03718767-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03718767-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 | 0.375 | 0.137 | 0.694 | wilson | |
| Risk in group 2 | 0.367 | 0.219 | 0.545 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00833 | -0.289 | 0.36 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.372 | 2.81 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.207 | 5.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1/Hypermutated Phenotype (HMP) than on Cohort 2/Non-hypermutated Phenotype (NHMP). | 120 | 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 | Cohort 1/Hypermutated Phenotype (HMP) | Isocitrate dehydrogenase (IDH) - mutant gliomas participants with hypermutated phenotype (HMP). Participants received Nivolumab 240mg every (q)2 weeks in Cycle 1 - Cycle 2 and then 480mg q4 weeks in Cycle 3-Cycle 16. | 3 | 8 | EG000 |
| Group 2 | Cohort 2/Non-hypermutated Phenotype (NHMP). | Isocitrate dehydrogenase (IDH) - mutant gliomas participants with non-hypermutated phenotype (NHMP). Participants received Nivolumab 240mg every (q)2 weeks in Cycle 1 - Cycle 2 and then 480mg q4 weeks in Cycle 3-Cycle 16. | 11 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-Cause Mortality was monitored/assessed up to a median of 7.4 months in cohort 1 and a median of 31.6 months in cohort 2. Adverse Events (AEs) were only collected from beginning of study participation to one month post study participation, a maximum of 17 months.
Source ClinicalTrials.gov
Trial
- Title
- Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
- NCT number
- NCT03718767
- Phases
- PHASE2
- Conditions
- Glioma, Glioblastoma, High Grade Glioma, Low Grade Glioma, Malignant Glioma
- Interventions
- Nivolumab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-11-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03718767?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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