Comparison · NCT00482677-sae
Temozolomide vs Radiation: 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. Temozolomide vs Radiation: serious adverse events. Trial comparisons, record NCT00482677-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00482677-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 | 0.583 | 0.524 | 0.64 | wilson | |
| Risk in group 2 | 0.498 | 0.439 | 0.557 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0849 | 0.00101 | 0.167 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 1 | 1.37 | log | |
| Odds ratio, group 1 over group 2 | 1.41 | 1 | 1.98 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Temozolomide than on Radiation | 11.8 | 5.99 | 993 | 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 | Temozolomide | Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study | 158 | 271 | EG000 |
| Group 2 | Radiation | Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy | 135 | 271 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT00482677
- Phases
- PHASE3
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- temozolomide, DNA methylation analysis, quality-of-life assessment, Radiation
- Lead sponsor
- Canadian Cancer Trials Group
- Results first posted
- 2018-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00482677?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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