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NCT01539512 · OUTCOME

Overall Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 17 months

What was measured

Overall survival was defined as the interval from randomization to death from any cause.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Idelalisib + RituximabNANot reportedNANANA = Not reached due to insufficient number of events
Placebo + RituximabNANot reported12.8NANA = Not reached due to insufficient number of events

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.11
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.69
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.28
Complete source fields
analyses
  1. ci Lower Limit
    0.11
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.69
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.28
classes
  1. categories
    1. measurements
      1. comment
        NA = Not reached due to insufficient number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA = Not reached due to insufficient number of events
        group Id
        OG001
        lower Limit
        12.8
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      110
    units
    Participants
description
Overall survival was defined as the interval from randomization to death from any cause.
dispersion Type
95% Confidence Interval
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
MEDIAN
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
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice