Comparison · NCT00085202-sae
Average-Risk Group vs High-Risk Group: 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. Average-Risk Group vs High-Risk Group: serious adverse events. Trial comparisons, record NCT00085202-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00085202-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 | 0.0632 | 0.0398 | 0.0989 | wilson | |
| Risk in group 2 | 0.118 | 0.075 | 0.181 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0549 | -0.122 | 0.00103 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.535 | 0.282 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.504 | 0.249 | 1.02 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Average-Risk Group than on High-Risk Group | 18.2 | 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 | Average-Risk Group | Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2). | 17 | 269 | EG000 |
| Group 2 | High-Risk Group | Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery. | 17 | 144 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.
Source ClinicalTrials.gov
Trial
- Title
- Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
- NCT number
- NCT00085202
- Phases
- PHASE3
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- filgrastim, cisplatin, cyclophosphamide, vincristine, autologous hematopoietic stem cell transplantation, radiation therapy
- Lead sponsor
- St. Jude Children's Research Hospital
- Results first posted
- 2014-02-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00085202?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
Read this comparison from software.
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