Comparison · NCT00404495-sae
Temozolomide + Irinotecan for Medulloblastoma vs Temozolomide + Irinotecan for High-Grade Glioma: 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 + Irinotecan for Medulloblastoma vs Temozolomide + Irinotecan for High-Grade Glioma: serious adverse events. Trial comparisons, record NCT00404495-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00404495-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 | 0.47 | 0.354 | 0.588 | wilson | |
| Risk in group 2 | 0.294 | 0.133 | 0.531 | wilson | |
| Risk difference, group 1 minus group 2 | 0.176 | -0.0882 | 0.376 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.6 | 0.732 | 3.48 | log | |
| Odds ratio, group 1 over group 2 | 2.13 | 0.673 | 6.71 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Temozolomide + Irinotecan for Medulloblastoma than on Temozolomide + Irinotecan for High-Grade Glioma | 5.7 | 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 | Temozolomide + Irinotecan for Medulloblastoma | For participants with medulloblastoma: Irinotecan 10 mg/m\^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m\^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression. | 31 | 66 | EG000 |
| Group 2 | Temozolomide + Irinotecan for High-Grade Glioma | For participants with high-grade glioma: Irinotecan 10 mg/m\^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m\^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy. | 5 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
- NCT number
- NCT00404495
- Phases
- PHASE2
- Conditions
- Glioma, Medulloblastoma
- Interventions
- Irinotecan, Temozolomide
- Lead sponsor
- Pfizer
- Results first posted
- 2012-02-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00404495?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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