NCT01722487 · OUTCOME

Proportion of Sustained Hemoglobin Improvement

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL · Source last updated 2017-11-30

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: Not reported
Time frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

What was measured

The proportion of subjects who achieved Hemoglobin \>11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.

Analysis population: Intention to treat

Groups in this outcome

Ibrutinib

Ibrutinib 420 mg daily.

Chlorambucil

Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles

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
Ibrutinib	136
Chlorambucil	133

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib	45.6	Not reported	Not reported	Not reported	Not reported
Chlorambucil	20.3	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Chi-squared

Complete source fields

analyses

group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
value
45.6
group Id
OG001
value
20.3

denoms

counts
group Id
OG000
value
136
group Id
OG001
value
133
units
Participants

description

The proportion of subjects who achieved Hemoglobin \>11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.

groups

description
Ibrutinib 420 mg daily.
id
OG000
title
Ibrutinib
description
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
id
OG001
title
Chlorambucil

param Type

NUMBER

population Description

Intention to treat

reporting Status

POSTED

time Frame

Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

title

Proportion of Sustained Hemoglobin Improvement

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice