NCT01611090 · OUTCOME

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2020-03-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline to EOT (up to 2 years)

What was measured

The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).

Analysis population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

Groups in this outcome

Ibrutinib+BR

Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.

Placebo+BR

Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.

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+BR	38
Placebo+BR	110

Reported measurements

Source class 1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib+BR	-4.3	19.58	Not reported	Not reported	Not reported
Placebo+BR	4.0	18.21	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
19.58
value
-4.3
group Id
OG001
spread
18.21
value
4.0

denoms

counts
group Id
OG000
value
38
group Id
OG001
value
110
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
id
OG000
title
Ibrutinib+BR
description
Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
id
OG001
title
Placebo+BR

param Type

MEAN

population Description

ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

reporting Status

POSTED

time Frame

Baseline to EOT (up to 2 years)

title

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Not medical advice