Comparison · NCT02306161-sae
Regimen A (VDC/IE) vs Regimen B (VDC/IE + Ganitumab): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. Regimen A (VDC/IE) vs Regimen B (VDC/IE + Ganitumab): serious adverse events. Trial comparisons, record NCT02306161-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02306161-sae
On this page
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 | 0.0207 | 0.00706 | 0.0591 | wilson | |
| Risk in group 2 | 0.3 | 0.232 | 0.378 | wilson | |
| Risk difference, group 1 minus group 2 | -0.279 | -0.358 | -0.202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.069 | 0.0219 | 0.217 | log | |
| Odds ratio, group 1 over group 2 | 0.0493 | 0.0149 | 0.163 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Regimen A (VDC/IE) than on Regimen B (VDC/IE + Ganitumab) | 3.58 | 2.79 | 4.96 | 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 (VDC/IE) | INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles.~LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.~CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles.~METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.~Cyclophosphamide: Given IV~Doxorubicin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Etoposide Phosphate: Given IV~External Beam Radiation Therapy: Undergo EBRT~Ifosfamide: Given IV~Stereotactic Radiosurgery: Undergo SBRT~Therapeutic Surgical Procedure: Undergo surgery~Vincristine: Given IV~Vincristine Sulfate: Given IV | 3 | 145 | EG000 |
| Group 2 | Regimen B (VDC/IE + Ganitumab) | INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.~LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.~CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.~METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.~MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.~Cyclophosphamide: Given IV~Doxorubicin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Etoposide Phosphate: Given IV~External Beam Radiation Therapy: Undergo EBRT~Ganitumab: Given IV~Ifosfamide: Given IV~Stereotactic Radiosurgery: Undergo SBRT~Therapeutic Surgical Procedure: Undergo surgery~Vincristine: Given IV~Vincristine Sulfate: Given IV | 45 | 150 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
- NCT number
- NCT02306161
- Phases
- PHASE3
- Conditions
Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Bone Marrow, Metastatic Malignant Neoplasm in the Lung, Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissues
- Interventions
Cyclophosphamide, Doxorubicin, Doxorubicin Hydrochloride, Etoposide, Etoposide Phosphate, External Beam Radiation Therapy, Ganitumab, Ifosfamide, Stereotactic Radiosurgery, Therapeutic Surgical Procedure, Vincristine, Vincristine Sulfate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2022-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02306161?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.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02306161-sae