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Comparison · NCT02947347-deaths

Arm A: Ibrutinib + Rituximab vs Arm B: Placebo + Rituximab: 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. Arm A: Ibrutinib + Rituximab vs Arm B: Placebo + Rituximab: deaths from any cause. Trial comparisons, record NCT02947347-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02947347-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 10.3680.3180.421wilson
Risk in group 20.360.2770.453wilson
Risk difference, group 1 minus group 20.0079-0.09730.107newcombe hybrid score
Risk ratio, group 1 over group 21.020.7691.36log
Odds ratio, group 1 over group 21.030.6621.62log
Number needed to harm, for one more death from any cause on Arm A: Ibrutinib + Rituximab than on Arm B: Placebo + Rituximab127from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm A: Ibrutinib + Rituximab
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
123334EG000
Group 2Arm B: Placebo + Rituximab
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
40111EG001

Harm

What it counts
Total, all-cause mortality
Time frame
All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).

Source ClinicalTrials.gov

Trial

Title
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
NCT number
NCT02947347
Phases
PHASE3
Conditions
Follicular Lymphoma
Interventions
Ibrutinib Oral Capsule, Placebo, Rituximab
Lead sponsor
Pharmacyclics LLC.
Results first posted
2026-03-17

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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