Comparison · NCT00027846-sae
Radiation (Group 2) vs Sub-Total Resection Any Histology or Location (STR) (Group 3): 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. Radiation (Group 2) vs Sub-Total Resection Any Histology or Location (STR) (Group 3): serious adverse events. Trial comparisons, record NCT00027846-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00027846-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 | 0.135 | 0.1 | 0.18 | wilson | |
| Risk in group 2 | 0.859 | 0.754 | 0.924 | wilson | |
| Risk difference, group 1 minus group 2 | -0.724 | -0.798 | -0.609 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.157 | 0.115 | 0.215 | log | |
| Odds ratio, group 1 over group 2 | 0.0256 | 0.0117 | 0.056 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Radiation (Group 2) than on Sub-Total Resection Any Histology or Location (STR) (Group 3) | 1.38 | 1.25 | 1.64 | 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 | Radiation (Group 2) | Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks | 38 | 281 | EG000 |
| Group 2 | Sub-Total Resection Any Histology or Location (STR) (Group 3) | Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient | 55 | 64 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
- NCT number
- NCT00027846
- Phases
- PHASE2
- Conditions
- Brain Tumor, Central Nervous System Tumor
- Interventions
- filgrastim, carboplatin, cyclophosphamide, etoposide, vincristine sulfate, radiation therapy, Mesna, therapeutic conventional surgery
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2017-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00027846?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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