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NCT03734016 · OUTCOME

Change From Baseline in European Quality of Life 5-dimensions 5-levels Health Questionnaire (EQ-5D-5L) Visual Analog Scale (VAS)

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Weeks 24 and 48

What was measured

The EQ-5D-5L VAS measures a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

Analysis population: Participants in the ITT Analysis Set who completed the EQ-5D-5L VAS at Baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point.

Groups in this outcome

Zanubrutinib

Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Ibrutinib

Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Zanubrutinib315
Ibrutinib315

Reported measurements

Week 24

Analysis denominator · Participants

GroupSource count
Zanubrutinib278
Ibrutinib260
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib7.9218.245Not reportedNot reportedNot reported
Ibrutinib3.4416.972Not reportedNot reportedNot reported
Week 48

Analysis denominator · Participants

GroupSource count
Zanubrutinib276
Ibrutinib254
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib7.7518.806Not reportedNot reportedNot reported
Ibrutinib3.9216.778Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.245
        value
        7.92
      2. group Id
        OG001
        spread
        16.972
        value
        3.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        278
      2. group Id
        OG001
        value
        260
      units
      Participants
    title
    Week 24
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.806
        value
        7.75
      2. group Id
        OG001
        spread
        16.778
        value
        3.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        276
      2. group Id
        OG001
        value
        254
      units
      Participants
    title
    Week 48
denoms
  1. counts
    1. group Id
      OG000
      value
      315
    2. group Id
      OG001
      value
      315
    units
    Participants
description
The EQ-5D-5L VAS measures a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    OG000
    title
    Zanubrutinib
  2. description
    Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    OG001
    title
    Ibrutinib
param Type
MEAN
population Description
Participants in the ITT Analysis Set who completed the EQ-5D-5L VAS at Baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point.
reporting Status
POSTED
time Frame
Baseline and Weeks 24 and 48
title
Change From Baseline in European Quality of Life 5-dimensions 5-levels Health Questionnaire (EQ-5D-5L) Visual Analog Scale (VAS)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice