Comparison · NCT01334515-sae
Disease Measured by Standard Radiographic Criteria vs Disease Evaluable Only by I-MIBG or BM Histology: 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. Disease Measured by Standard Radiographic Criteria vs Disease Evaluable Only by I-MIBG or BM Histology: serious adverse events. Trial comparisons, record NCT01334515-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01334515-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 | 0.438 | 0.231 | 0.668 | wilson | |
| Risk in group 2 | 0.5 | 0.345 | 0.655 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0625 | -0.321 | 0.216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.875 | 0.459 | 1.67 | log | |
| Odds ratio, group 1 over group 2 | 0.778 | 0.238 | 2.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Disease Measured by Standard Radiographic Criteria than on Disease Evaluable Only by I-MIBG or BM Histology | 16 | 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 | Disease Measured by Standard Radiographic Criteria | Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC \[preferred\]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies | 7 | 16 | EG000 |
| Group 2 | Disease Evaluable Only by I-MIBG or BM Histology | Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC \[preferred\]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies | 18 | 36 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma
- NCT number
- NCT01334515
- Phases
- PHASE2
- Conditions
- Recurrent Neuroblastoma
- Interventions
- hu14.18-IL2 fusion protein, isotretinoin, sargramostim, laboratory biomarker analysis
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2015-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01334515?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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