Comparison · NCT00054665-sae
Part A: PS-341 Alone vs Part B: PS-341 & EPOCH: 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. Part A: PS-341 Alone vs Part B: PS-341 & EPOCH: serious adverse events. Trial comparisons, record NCT00054665-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00054665-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 | 0.875 | 0.69 | 0.957 | wilson | |
| Risk in group 2 | 0.909 | 0.788 | 0.964 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0341 | -0.227 | 0.112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.963 | 0.806 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.7 | 0.143 | 3.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Part A: PS-341 Alone than on Part B: PS-341 & EPOCH | 29.3 | 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 | Part A: PS-341 Alone | PS-341 1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks | 21 | 24 | EG000 |
| Group 2 | Part B: PS-341 & EPOCH | PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycles every 21 days. | 40 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma
- NCT number
- NCT00054665
- Phases
- PHASE2
- Conditions
- B-Cell Lymphoma
- Interventions
- PS-341, Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone, Filgrastim
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2012-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00054665?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/NCT00054665-sae