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NCT01539512 · OUTCOME

Lymph Node 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
95% Confidence Interval
Time frame
Up to 17 months

What was measured

Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.

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: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Idelalisib + Rituximab92.2Not reported85.196.6Not reported
Placebo + Rituximab5.9Not reported2.212.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        85.1
        upper Limit
        96.6
        value
        92.2
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        12.5
        value
        5.9
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      110
    units
    Participants
description
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
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
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
Lymph Node Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice