Comparison · NCT00354835-sae
Vincristine, Dactinomycin, Cyclophosphamide (VAC) vs VAC Alternating With VI: 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. Vincristine, Dactinomycin, Cyclophosphamide (VAC) vs VAC Alternating With VI: serious adverse events. Trial comparisons, record NCT00354835-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00354835-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 | 0.018 | 0.00703 | 0.0454 | wilson | |
| Risk in group 2 | 0.0487 | 0.0274 | 0.085 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0307 | -0.0686 | 0.00403 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.37 | 0.12 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.359 | 0.112 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vincristine, Dactinomycin, Cyclophosphamide (VAC) than on VAC Alternating With VI | 32.6 | 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 | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV~Cyclophosphamide: Given IV~Vincristine Sulfate: Given IV~Radiation Therapy: Undergo radiotherapy~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies | 4 | 222 | EG000 |
| Group 2 | VAC Alternating With VI | Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Irinotecan Hydrochloride: Given IV~Dactinomycin: Given IV~Cyclophosphamide: Given IV~Vincristine Sulfate: Given IV~Radiation Therapy: Undergo radiotherapy~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies | 11 | 226 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
- NCT number
- NCT00354835
- Phases
- PHASE3
- Conditions
Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Botryoid-Type Embryonal Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Localized Childhood Soft Tissue Sarcoma, Rhabdomyosarcoma, Sarcoma, Stage I Adult Soft Tissue Sarcoma AJCC v7, Stage II Adult Soft Tissue Sarcoma AJCC v7, Stage III Adult Soft Tissue Sarcoma AJCC v7
- Interventions
- Cyclophosphamide, Dactinomycin, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Questionnaire Administration, Radiation Therapy, Vincristine Sulfate
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2017-07-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00354835?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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