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NCT01889186 · OUTCOME

Duration of Overall Response

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
MEDIAN
Unit
months
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

Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis.

Analysis population: All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data

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 Cohort80
Safety Expansion Cohort42

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Cohort35.3Not reported26.5NANot calculable/estimable due to insufficient number of events
Safety Expansion CohortNANot reported27.3NANot calculable/estimable due to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not calculable/estimable due to insufficient number of events
        group Id
        OG000
        lower Limit
        26.5
        upper Limit
        NA
        value
        35.3
      2. comment
        Not calculable/estimable due to insufficient number of events
        group Id
        OG001
        lower Limit
        27.3
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    2. group Id
      OG001
      value
      42
    units
    Participants
description
Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis.
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
MEDIAN
population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data
reporting Status
POSTED
time Frame
Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
title
Duration of Overall Response
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice