Comparison · NCT00433381-sae
Arm I (Bevacizumab and Temozolomide) vs Arm II (Bevacizumab and Irinotecan Hydrochloride): 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 (Bevacizumab and Temozolomide) vs Arm II (Bevacizumab and Irinotecan Hydrochloride): serious adverse events. Trial comparisons, record NCT00433381-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00433381-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 | 0.617 | 0.49 | 0.729 | wilson | |
| Risk in group 2 | 0.649 | 0.519 | 0.76 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0325 | -0.201 | 0.139 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.721 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 0.87 | 0.41 | 1.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Bevacizumab and Temozolomide) than on Arm II (Bevacizumab and Irinotecan Hydrochloride) | 30.8 | 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 (Bevacizumab and Temozolomide) | Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60. | 37 | 60 | EG000 |
| Group 2 | Arm II (Bevacizumab and Irinotecan Hydrochloride) | Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients. | 37 | 57 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
- NCT number
- NCT00433381
- Phases
- PHASE2
- Conditions
- Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm
- Interventions
- Bevacizumab, Irinotecan Hydrochloride, Temozolomide
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2013-05-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00433381?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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