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NCT01539512 · OUTCOME

Complete Response Rate

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) · Source last updated 2019-05-14

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
Up to 17 months

What was measured

Complete response rate was defined as the percentage of participants who achieved a complete response.

Analysis population: ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.

Groups in this outcome

Idelalisib + Rituximab

Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)

Placebo + Rituximab

Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)

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

Analysis denominator · Participants

GroupSource count
Idelalisib + Rituximab110
Placebo + Rituximab110

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib + Rituximab0Not reportedNot reportedNot reportedNot reported
Placebo + Rituximab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      110
    units
    Participants
description
Complete response rate was defined as the percentage of participants who achieved a complete response.
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
    id
    OG000
    title
    Idelalisib + Rituximab
  2. description
    Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
    id
    OG001
    title
    Placebo + Rituximab
param Type
NUMBER
population Description
ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
reporting Status
POSTED
time Frame
Up to 17 months
title
Complete Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice