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NCT01889186 · OUTCOME

Complete Remission (CR) Rate

A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion · Source last updated 2021-12-16

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 the data cutoff date of 15 June 2017, approximately 4 years of follow-up

What was measured

Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate.

Analysis population: All treated participants in the Main Cohort and the Safety Expansion Cohort

Groups in this outcome

Main Cohort

Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.

Safety Expansion Cohort

Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.

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

Analysis denominator · Participants

GroupSource count
Main Cohort107
Safety Expansion Cohort51

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Cohort21.5Not reported14.130.5Not reported
Safety Expansion Cohort27.5Not reported15.941.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.1
        upper Limit
        30.5
        value
        21.5
      2. group Id
        OG001
        lower Limit
        15.9
        upper Limit
        41.7
        value
        27.5
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      51
    units
    Participants
description
Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    OG000
    title
    Main Cohort
  2. description
    Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    OG001
    title
    Safety Expansion Cohort
param Type
NUMBER
population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort
reporting Status
POSTED
time Frame
Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
title
Complete Remission (CR) Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice