Comparison · NCT00001337-sae
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): 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. With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): serious adverse events. Trial comparisons, record NCT00001337-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00001337-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 | 0.621 | 0.558 | 0.681 | wilson | |
| Risk in group 2 | 0.393 | 0.307 | 0.485 | wilson | |
| Risk difference, group 1 minus group 2 | 0.228 | 0.116 | 0.333 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.58 | 1.23 | 2.03 | log | |
| Odds ratio, group 1 over group 2 | 2.54 | 1.6 | 4.02 | log | |
Number needed to harm, for one more participant with a serious adverse event on With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) than on EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 4.38 | 3.01 | 8.61 | 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 | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. | 146 | 235 | EG000 |
| Group 2 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. | 44 | 112 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
- NCT number
- NCT00001337
- Phases
- PHASE2
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma, Burkitt Lymphoma, Anaplastic Large-Cell Lymphoma, Gray Zone Lymphoma
- Interventions
- Etoposide, Rituximab, Prednisone, Cyclophosphamide, Vincristine, Doxorubicin, MRI, CT, Biopsy, PET scan, Laparotomy, Ondansetron, Prochlorperazine, Omeprazole, Docusate Sodium + Sennosides, Lactulose
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00001337?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.
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