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NCT02005471 · OUTCOME

Percentage of Participants Who Died

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) · Source last updated 2023-10-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to approximately 8 years 5 months

What was measured

Percentage of participants who died from any cause, during the study, was reported. Percentage is rounded off.

Analysis population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Groups in this outcome

Bendamustine + Rituximab Main Study

Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

Venetoclax + Rituximab Main Study

Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bendamustine + Rituximab Main Study195
Venetoclax + Rituximab Main Study194

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine + Rituximab Main Study43.1Not reportedNot reportedNot reportedNot reported
Venetoclax + Rituximab Main Study30.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        43.1
      2. group Id
        OG001
        value
        30.9
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    2. group Id
      OG001
      value
      194
    units
    Participants
description
Percentage of participants who died from any cause, during the study, was reported. Percentage is rounded off.
groups
  1. description
    Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    OG000
    title
    Bendamustine + Rituximab Main Study
  2. description
    Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    OG001
    title
    Venetoclax + Rituximab Main Study
param Type
NUMBER
population Description
ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
Baseline up to approximately 8 years 5 months
title
Percentage of Participants Who Died
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice