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NCT02141282 · OUTCOME

Overall Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
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

Overall response rate is defined as the percentage of participants with an overall response (per the investigator assessment) 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) criteria.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts64.8Not reported54.174.6Not reported
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts69.4Not reported51.983.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.1
        upper Limit
        74.6
        value
        64.8
      2. group Id
        OG001
        lower Limit
        51.9
        upper Limit
        83.7
        value
        69.4
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      36
    units
    Participants
description
Overall response rate is defined as the percentage of participants with an overall response (per the investigator assessment) 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) criteria.
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
NUMBER
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 Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice