Comparison · NCT01938001-sae
Rituximab + Lenalidomide (R^2) vs Rituximab + Placebo: 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. Rituximab + Lenalidomide (R^2) vs Rituximab + Placebo: serious adverse events. Trial comparisons, record NCT01938001-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01938001-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 | 0.256 | 0.197 | 0.325 | wilson | |
| Risk in group 2 | 0.139 | 0.0959 | 0.197 | wilson | |
| Risk difference, group 1 minus group 2 | 0.117 | 0.0342 | 0.198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.84 | 1.18 | 2.87 | log | |
| Odds ratio, group 1 over group 2 | 2.13 | 1.24 | 3.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rituximab + Lenalidomide (R^2) than on Rituximab + Placebo | 8.56 | 5.04 | 29.3 | 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 | Rituximab + Lenalidomide (R^2) | Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days. | 45 | 176 | EG000 |
| Group 2 | Rituximab + Placebo | Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles. | 25 | 180 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 100 months).
Source ClinicalTrials.gov
Trial
- Title
- Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
- NCT number
- NCT01938001
- Phases
- PHASE3
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Rituximab, Lenalidomide, Placebo
- Lead sponsor
- Celgene
- Results first posted
- 2019-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01938001?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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