Comparison · NCT01055314-sae
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) vs Group 2 (Chemotherapy, Radiation Therapy, Temozolomide): 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. Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) vs Group 2 (Chemotherapy, Radiation Therapy, Temozolomide): serious adverse events. Trial comparisons, record NCT01055314-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01055314-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 | 0.823 | 0.735 | 0.886 | wilson | |
| Risk in group 2 | 0.571 | 0.455 | 0.681 | wilson | |
| Risk difference, group 1 minus group 2 | 0.251 | 0.111 | 0.384 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.44 | 1.15 | 1.8 | log | |
| Odds ratio, group 1 over group 2 | 3.49 | 1.72 | 7.06 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) than on Group 2 (Chemotherapy, Radiation Therapy, Temozolomide) | 3.98 | 2.6 | 9.01 | 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 | Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) | Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50 \& 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47 \& 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, \& 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28 \& 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 \& 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41 \& 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24.~Cixutumumab: Given IV~Cyclophosphamide: Given IV~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Vincristine Sulfate | 79 | 96 | EG000 |
| Group 2 | Group 2 (Chemotherapy, Radiation Therapy, Temozolomide) | Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.~Cyclophosphamide: Given IV~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Vincristine Sulfate Liposome: Given IV | 40 | 70 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
- NCT number
- NCT01055314
- Phases
- PHASE2
- Conditions
Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Metastatic Childhood Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Untreated Childhood Rhabdomyosarcoma
- Interventions
- Cixutumumab, Cyclophosphamide, Dactinomycin, Doxorubicin Hydrochloride, Etoposide, Ifosfamide, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Temozolomide, Vincristine Sulfate Liposome
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01055314?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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