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NCT03846427 · OUTCOME

Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status

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 EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a positive score from baseline indicating 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
Zanubrutinib58
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib7.47119.5396Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Zanubrutinib49
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib7.82315.8121Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Zanubrutinib48
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib5.38220.0833Not reportedNot reportedNot reported
Cycle 12

Analysis denominator · Participants

GroupSource count
Zanubrutinib42
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib7.14317.3216Not reportedNot reportedNot reported
Cycle 18

Analysis denominator · Participants

GroupSource count
Zanubrutinib32
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib10.67718.4811Not reportedNot reportedNot reported
Cycle 24

Analysis denominator · Participants

GroupSource count
Zanubrutinib35
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib9.28619.2561Not reportedNot reportedNot reported
Cycle 30

Analysis denominator · Participants

GroupSource count
Zanubrutinib28
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib6.25020.4910Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.5396
        value
        7.471
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Cycle 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.8121
        value
        7.823
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      units
      Participants
    title
    Cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.0833
        value
        5.382
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      units
      Participants
    title
    Cycle 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.3216
        value
        7.143
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Cycle 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.4811
        value
        10.677
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    Cycle 18
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.2561
        value
        9.286
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.4910
        value
        6.250
    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 EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a positive score from baseline indicating 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 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice