Participant flow

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.

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

   FG000

   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

   FG001

   title

   Placebo + Rituximab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         5

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Richter's Transformation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         110

      2. group Id

         FG001

         num Subjects

         110

      type

      STARTED

   2. achievements

      1. comment

         Completed=reached primary efficacy endpoint (progressive disease or death) or finished study period.

         group Id

         FG000

         num Subjects

         87

      2. comment

         Completed=reached primary efficacy endpoint (progressive disease or death) or finished study period.

         group Id

         FG001

         num Subjects

         97

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         13

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were enrolled at a total of 53 study sites in the United States and Europe. The first participant was screened on 03 April 2012. The last study visit occurred on 20 April 2014.

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Preserved source evidence · Not medical advice