Comparison · NCT01217437-sae
Arm I (Temozolomide, Irinotecan Hydrochloride) vs Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab): 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. Arm I (Temozolomide, Irinotecan Hydrochloride) vs Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab): serious adverse events. Trial comparisons, record NCT01217437-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01217437-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 | 0.167 | 0.0902 | 0.287 | wilson | |
| Risk in group 2 | 0.231 | 0.137 | 0.361 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0641 | -0.215 | 0.0886 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.722 | 0.332 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.254 | 1.75 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Temozolomide, Irinotecan Hydrochloride) than on Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | 15.6 | 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 | Arm I (Temozolomide, Irinotecan Hydrochloride) | Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO | 9 | 54 | EG000 |
| Group 2 | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.~Bevacizumab: Given IV~Irinotecan Hydrochloride: Given IV~Temozolomide: Given PO | 12 | 52 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 cycles (planned 336 days of protocol therapy)
Source ClinicalTrials.gov
Trial
- Title
- Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
- NCT number
- NCT01217437
- Phases
- PHASE2
- Conditions
- Central Nervous System Neoplasm, Pineoblastoma, Recurrent Medulloblastoma, Recurrent Primitive Neuroectodermal Tumor, Refractory Medulloblastoma, Refractory Peripheral Primitive Neuroectodermal Tumor
- Interventions
- Bevacizumab, Irinotecan Hydrochloride, Temozolomide
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2019-09-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01217437?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
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GET https://conductscience.org/api/comparisons/v1/NCT01217437-sae