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NCT03846427 · OUTCOME

Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)

Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma · Source last updated 2024-10-26

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 to Cycle 30 (28 days per cycle)

What was measured

Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record 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.' Positive change from baseline indicates improved health.

Analysis population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug

Groups in this outcome

Zanubrutinib

Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent

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

Analysis denominator · Participants

GroupSource count
Zanubrutinib66

Reported measurements

Cycle 3

Analysis denominator · Participants

GroupSource count
Zanubrutinib57
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib1.018.18Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Zanubrutinib50
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib2.215.78Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Zanubrutinib47
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib0.216.28Not reportedNot reportedNot reported
Cycle 12

Analysis denominator · Participants

GroupSource count
Zanubrutinib42
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib2.816.15Not reportedNot reportedNot reported
Cycle 18

Analysis denominator · Participants

GroupSource count
Zanubrutinib33
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib5.617.68Not reportedNot reportedNot reported
Cycle 24

Analysis denominator · Participants

GroupSource count
Zanubrutinib35
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib5.815.24Not reportedNot reportedNot reported
Cycle 30

Analysis denominator · Participants

GroupSource count
Zanubrutinib28
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib1.618.15Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.18
        value
        1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Cycle 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.78
        value
        2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.28
        value
        0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    Cycle 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.15
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Cycle 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.68
        value
        5.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    Cycle 18
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.24
        value
        5.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.15
        value
        1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Cycle 30
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    units
    Participants
description
Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record 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.' Positive change from baseline indicates improved health.
dispersion Type
Standard Deviation
groups
  1. description
    Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
    id
    OG000
    title
    Zanubrutinib
param Type
MEAN
population Description
Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
Baseline to Cycle 30 (28 days per cycle)
title
Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice