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NCT02141282 · OUTCOME

Overall Survival (OS)

A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy · Source last updated 2022-12-19

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
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort

What was measured

OS is defined as the number of days from the date of first dose to the date of death for all dosed participants. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. OS was estimated using Kaplan-Meier methodology.

Analysis population: All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax

Groups in this outcome

ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts

Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts

ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts

Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts

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

Analysis denominator · Participants

GroupSource count
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts91
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts36

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts69.6Not reported51.3NANot calculable/estimable due to low number of participants with events
ABT-199 After Idelalisib Therapy: Main and Expansion CohortsNANot reported57.2NANot calculable/estimable due to low number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not calculable/estimable due to low number of participants with events
        group Id
        OG000
        lower Limit
        51.3
        upper Limit
        NA
        value
        69.6
      2. comment
        Not calculable/estimable due to low number of participants with events
        group Id
        OG001
        lower Limit
        57.2
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      36
    units
    Participants
description
OS is defined as the number of days from the date of first dose to the date of death for all dosed participants. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. OS was estimated using Kaplan-Meier methodology.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
    id
    OG000
    title
    ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
  2. description
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
    id
    OG001
    title
    ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
param Type
MEDIAN
population Description
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax
reporting Status
POSTED
time Frame
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice