NCT01889186 · OUTCOME

Percentage of Participants Who Moved on to Stem Cell Transplant

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 percentage of participants who moved on to stem cell transplant was summarized.

Analysis population: All treated participants with 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.

All Treated Participants

Participants in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, 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

Group	Source count
Main Cohort	107
All Treated Participants	158

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Main Cohort	2.8	Not reported	0.6	8.0	Not reported
All Treated Participants	2.5	Not reported	0.7	6.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.6
upper Limit
8.0
value
2.8
group Id
OG001
lower Limit
0.7
upper Limit
6.4
value
2.5

denoms

counts
group Id
OG000
value
107
group Id
OG001
value
158
units
Participants

description

The percentage of participants who moved on to stem cell transplant was summarized.

dispersion Type

95% Confidence Interval

groups

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
description
Participants in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, 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
All Treated Participants

param Type

NUMBER

population Description

All treated participants with available data

reporting Status

POSTED

time Frame

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

title

Percentage of Participants Who Moved on to Stem Cell Transplant

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice