Comparison · NCT02048813-deaths
Arm A (Ibrutinib, Rituximab) vs Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide): deaths from any cause
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. Arm A (Ibrutinib, Rituximab) vs Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide): deaths from any cause. Trial comparisons, record NCT02048813-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02048813-deaths
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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 | 0.0113 | 0.0044 | 0.0287 | wilson | |
| Risk in group 2 | 0.0571 | 0.0313 | 0.102 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0458 | -0.0912 | -0.0147 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.198 | 0.0629 | 0.622 | log | |
| Odds ratio, group 1 over group 2 | 0.189 | 0.0583 | 0.61 | log | |
| Number needed to treat, for one fewer death from any cause on Arm A (Ibrutinib, Rituximab) than on Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 21.8 | 11 | 67.9 | 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 | Arm A (Ibrutinib, Rituximab) | Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD. | 4 | 354 | EG000 |
| Group 2 | Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity. | 10 | 175 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Source ClinicalTrials.gov
Trial
- Title
- Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- NCT number
- NCT02048813
- Phases
- PHASE3
- Conditions
- Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study, Quality-of-Life Assessment, Rituximab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02048813?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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