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Comparison · NCT01938001-deaths

Rituximab + Lenalidomide (R^2) vs Rituximab + Placebo: 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

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ConductScience Library. Rituximab + Lenalidomide (R^2) vs Rituximab + Placebo: deaths from any cause. Trial comparisons, record NCT01938001-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01938001-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1520.1060.212wilson
Risk in group 20.2610.2020.33wilson
Risk difference, group 1 minus group 2-0.109-0.192-0.0255newcombe hybrid score
Risk ratio, group 1 over group 20.5810.380.889log
Odds ratio, group 1 over group 20.5060.2990.858log
Number needed to treat, for one fewer death from any cause on Rituximab + Lenalidomide (R^2) than on Rituximab + Placebo9.145.2239.2from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Rituximab + 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.
27178EG000
Group 2Rituximab + 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.
47180EG001

Harm

What it counts
Total, all-cause mortality
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

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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