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Comparison · NCT02367040-deaths

Copanlisib + Rituximab vs 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. Copanlisib + Rituximab vs Placebo + Rituximab: deaths from any cause. Trial comparisons, record NCT02367040-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02367040-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 10.3220.2730.377wilson
Risk in group 20.3420.270.423wilson
Risk difference, group 1 minus group 2-0.02-0.1140.0702newcombe hybrid score
Risk ratio, group 1 over group 20.9420.7141.24log
Odds ratio, group 1 over group 20.9140.6021.39log
Number needed to treat, for one fewer death from any cause on Copanlisib + Rituximab than on Placebo + Rituximab50from 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 1Copanlisib + Rituximab
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
99307EG000
Group 2Placebo + Rituximab
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
50146EG001

Harm

What it counts
Total, all-cause mortality
Time frame
- Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.

Source ClinicalTrials.gov

Trial

Title
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
NCT number
NCT02367040
Phases
PHASE3
Conditions
Lymphoma,Non-Hodgkin
Interventions
Copanlisib (Aliqopa, BAY80-6946), Placebo, Rituximab
Lead sponsor
Bayer
Results first posted
2022-01-04

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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