Comparison · NCT00057811-sae
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) vs Group C (Chemotherapy, Monoclonal Antibody Therapy): 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 B (Chemotherapy, Protective Therapy, Monoclonal Antib.) vs Group C (Chemotherapy, Monoclonal Antibody Therapy): serious adverse events. Trial comparisons, record NCT00057811-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00057811-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 | 0.0435 | 0.012 | 0.145 | wilson | |
| Risk in group 2 | 0.143 | 0.0672 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0994 | -0.239 | 0.0275 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.304 | 0.0649 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.273 | 0.0519 | 1.43 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) than on Group C (Chemotherapy, Monoclonal Antibody Therapy) | 10.1 | 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 | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description. | 2 | 46 | EG000 |
| Group 2 | Group C (Chemotherapy, Monoclonal Antibody Therapy) | Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description. | 6 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
- NCT number
- NCT00057811
- Phases
- PHASE2
- Conditions
Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Untreated Childhood Acute Lymphoblastic Leukemia
- Interventions
doxorubicin hydrochloride, cyclophosphamide, methotrexate, rasburicase, leucovorin calcium, prednisone, methylprednisolone, filgrastim, rituximab, cytarabine, etoposide, vincristine sulfate, hydrocortisone sodium succinate, laboratory biomarker analysis
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2014-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00057811?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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