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NCT01611090 · OUTCOME

Overall Survival (OS)

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2020-03-03

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

OS was defined as the interval between the date of randomization and the date of death from any cause.

Analysis population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.

Groups in this outcome

Ibrutinib+BR

Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.

Placebo+BR

Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR289
Placebo+BR289

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ibrutinib+BRNANot reported70.93NAHere, NA indicates median and upper limit of CI was not estimable due to insufficient number of events.
Placebo+BRNANot reportedNANAHere, NA indicates median and CI was not estimable due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here, NA indicates median and upper limit of CI was not estimable due to insufficient number of events.
        group Id
        OG000
        lower Limit
        70.93
        upper Limit
        NA
        value
        NA
      2. comment
        Here, NA indicates median and CI was not estimable due to insufficient number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      289
    2. group Id
      OG001
      value
      289
    units
    Participants
description
OS was defined as the interval between the date of randomization and the date of death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Ibrutinib+BR
  2. description
    Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Placebo+BR
param Type
MEDIAN
population Description
Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.
reporting Status
POSTED
time Frame
Up to 5 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice