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NCT01611090 · OUTCOME

Number of Participants Who Received Subsequent Antineoplastic Therapy

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Number of participants who received subsequent antineoplastic therapy was reported.

Analysis population: Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.

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+BR287
Placebo+BR287

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ibrutinib+BR52Not reportedNot reportedNot reportedNot reported
Placebo+BR61Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        61
denoms
  1. counts
    1. group Id
      OG000
      value
      287
    2. group Id
      OG001
      value
      287
    units
    Participants
description
Number of participants who received subsequent antineoplastic therapy was reported.
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
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
reporting Status
POSTED
time Frame
Up to 5 years
title
Number of Participants Who Received Subsequent Antineoplastic Therapy
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice