Comparison · NCT00253435-sae
Poor Risk Patients vs Good Risk Patients: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Poor Risk Patients vs Good Risk Patients: serious adverse events. Trial comparisons, record NCT00253435-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00253435-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 | 0.286 | 0.172 | 0.436 | wilson | |
| Risk in group 2 | 0.375 | 0.137 | 0.694 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0893 | -0.428 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.762 | 0.276 | 2.1 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.137 | 3.24 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Poor Risk Patients than on Good Risk Patients | 11.2 | 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 | Poor Risk Patients | Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction. | 12 | 42 | EG000 |
| Group 2 | Good Risk Patients | Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction. | 3 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
- NCT number
- NCT00253435
- Phases
- PHASE2
- Conditions
- Neuroblastoma
- Interventions
- Filgrastim, Carboplatin, Etoposide, Melphalan, Peripheral blood stem cell infusion, 131I-MIBG, Radiation therapy
- Lead sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- Results first posted
- 2016-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00253435?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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GET https://conductscience.org/api/comparisons/v1/NCT00253435-sae