Comparison · NCT01602666-sae
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) vs Stratum 2 Localized Germinoma: 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. Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) vs Stratum 2 Localized Germinoma: serious adverse events. Trial comparisons, record NCT01602666-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01602666-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 | 0.0467 | 0.0201 | 0.105 | wilson | |
| Risk in group 2 | 0.0073 | 0.00129 | 0.0402 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0394 | -0.00287 | 0.0978 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.4 | 0.759 | 54 | log | |
| Odds ratio, group 1 over group 2 | 6.67 | 0.767 | 57.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) than on Stratum 2 Localized Germinoma | 25.4 | 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 | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks. | 5 | 107 | EG000 |
| Group 2 | Stratum 2 Localized Germinoma | Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks. | 1 | 137 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From initiation of induction of therapy to the date of last follow-up, approximately 3 years. For most subjects the adverse events were observed while on active treatment or shortly thereafter.
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
- NCT number
- NCT01602666
- Phases
- PHASE2
- Conditions
- Central Nervous System Nongerminomatous Germ Cell Tumor, Childhood Germinoma
- Interventions
- 3-Dimensional Conformal Radiation Therapy, Carboplatin, Etoposide, Ifosfamide, Intensity-Modulated Radiation Therapy
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2020-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01602666?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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