Comparison · NCT03794349-sae
Regimen A (Chemotherapy, Dinutuximab, Sargramostim) vs Regimen B (Eflornithine, Chemotherapy, Dinutuximab): 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. Regimen A (Chemotherapy, Dinutuximab, Sargramostim) vs Regimen B (Eflornithine, Chemotherapy, Dinutuximab): serious adverse events. Trial comparisons, record NCT03794349-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03794349-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 | 0.0682 | 0.0235 | 0.182 | wilson | |
| Risk in group 2 | 0.426 | 0.295 | 0.567 | wilson | |
| Risk difference, group 1 minus group 2 | -0.357 | -0.506 | -0.184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.16 | 0.0512 | 0.502 | log | |
| Odds ratio, group 1 over group 2 | 0.0988 | 0.0267 | 0.365 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Regimen A (Chemotherapy, Dinutuximab, Sargramostim) than on Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | 2.8 | 1.98 | 5.43 | 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 | Regimen A (Chemotherapy, Dinutuximab, Sargramostim) | Patients receive temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. | 3 | 44 | EG000 |
| Group 2 | Regimen B (Eflornithine, Chemotherapy, Dinutuximab) | Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21 of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Treatment duration is 28 days for cycle 1 and then every 21 days in subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. | 20 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 years after enrollment
Source ClinicalTrials.gov
Trial
- Title
- Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
- NCT number
- NCT03794349
- Phases
- PHASE2
- Conditions
- High Risk Neuroblastoma, Recurrent Neuroblastoma, Refractory Neuroblastoma
- Interventions
- Dinutuximab, Eflornithine Hydrochloride, Irinotecan Hydrochloride, Sargramostim, Temozolomide
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2026-01-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03794349?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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