Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01889186 · OUTCOME

Overall Response Rate (ORR) (Safety Expansion Cohort)

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

The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission \[CR\] + complete remission with incomplete marrow recovery \[CRi\] + nodular partial remission \[nPR\] + partial remission \[PR\]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria.

Analysis population: All treated participants in the Safety Expansion Cohort

Groups in this outcome

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
Safety Expansion Cohort51

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety Expansion Cohort82.4Not reported69.191.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.1
        upper Limit
        91.6
        value
        82.4
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission \[CR\] + complete remission with incomplete marrow recovery \[CRi\] + nodular partial remission \[nPR\] + partial remission \[PR\]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Safety Expansion Cohort
param Type
NUMBER
population Description
All treated participants in 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
Overall Response Rate (ORR) (Safety Expansion Cohort)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice