Comparison · NCT00075582-sae
Regimen I (Chemotherapy, Radiotherapy) vs Regimen II (Chemotherapy, Radiotherapy, Surgery): 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 I (Chemotherapy, Radiotherapy) vs Regimen II (Chemotherapy, Radiotherapy, Surgery): serious adverse events. Trial comparisons, record NCT00075582-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00075582-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 | 0.00368 | 0.000649 | 0.0205 | wilson | |
| Risk in group 2 | 0.0143 | 0.00253 | 0.0766 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0106 | -0.073 | 0.00994 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.257 | 0.0163 | 4.06 | log | |
| Odds ratio, group 1 over group 2 | 0.255 | 0.0157 | 4.12 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Regimen I (Chemotherapy, Radiotherapy) than on Regimen II (Chemotherapy, Radiotherapy, Surgery) | 94.3 | 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 | Regimen I (Chemotherapy, Radiotherapy) | Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy | 1 | 272 | EG000 |
| Group 2 | Regimen II (Chemotherapy, Radiotherapy, Surgery) | Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy | 1 | 70 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
- NCT number
- NCT00075582
- Phases
- PHASE3
- Conditions
- Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma
- Interventions
- conventional surgery, dactinomycin, cyclophosphamide, vincristine sulfate, radiation therapy
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2014-04-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00075582?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/NCT00075582-sae