Comparison · NCT00275002-sae
Recurrent High-Grade Gliomas vs Recurrent Brain Stem Tumors: 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. Recurrent High-Grade Gliomas vs Recurrent Brain Stem Tumors: serious adverse events. Trial comparisons, record NCT00275002-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00275002-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 | 0.6 | 0.407 | 0.766 | wilson | |
| Risk in group 2 | 0.75 | 0.505 | 0.898 | wilson | |
| Risk difference, group 1 minus group 2 | -0.15 | -0.393 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.8 | 0.522 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.125 | 2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Recurrent High-Grade Gliomas than on Recurrent Brain Stem Tumors | 6.67 | 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 | Recurrent High-Grade Gliomas | Participants with recurrent or progressive high-grade gliomas receive 120 mg/m\^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m\^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks. | 15 | 25 | EG000 |
| Group 2 | Recurrent Brain Stem Tumors | Participants with recurrent or progressive brain stem tumors receive 120 mg/m\^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m\^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks. | 12 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occur after the patient is off the study are also collected.
Source ClinicalTrials.gov
Trial
- Title
- O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors
- NCT number
- NCT00275002
- Phases
- PHASE2
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- O6-benzylguanine, temozolomide
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2011-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00275002?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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