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NCT02075840 · OUTCOME

HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

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

Measure
MEDIAN
Unit
Score on a scale
Interval / dispersion
Full Range
Time frame
Baseline, every 4 weeks until disease progression (up to 33 months)

What was measured

The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

Analysis population: ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.

Groups in this outcome

Alectinib

Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Crizotinib

Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

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

Analysis denominator · Participants

GroupSource count
Alectinib152
Crizotinib151

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Alectinib100
Crizotinib96
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib33.33Not reported0.0100.0Not reported
Treatment - week 4

Analysis denominator · Participants

GroupSource count
Alectinib95
Crizotinib89
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib33.33Not reported0.0100.0Not reported
Treatment - week 8

Analysis denominator · Participants

GroupSource count
Alectinib89
Crizotinib84
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib33.33Not reported0.0100.0Not reported
Treatment - week 12

Analysis denominator · Participants

GroupSource count
Alectinib75
Crizotinib78
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 16

Analysis denominator · Participants

GroupSource count
Alectinib79
Crizotinib73
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 20

Analysis denominator · Participants

GroupSource count
Alectinib73
Crizotinib67
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 24

Analysis denominator · Participants

GroupSource count
Alectinib77
Crizotinib71
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib33.33Not reported0.0100.0Not reported
Treatment - week 28

Analysis denominator · Participants

GroupSource count
Alectinib67
Crizotinib62
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib16.67Not reported0.0100.0Not reported
Treatment - week 32

Analysis denominator · Participants

GroupSource count
Alectinib73
Crizotinib65
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib33.33Not reported0.0100.0Not reported
Treatment - week 36

Analysis denominator · Participants

GroupSource count
Alectinib64
Crizotinib61
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 40

Analysis denominator · Participants

GroupSource count
Alectinib74
Crizotinib50
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 44

Analysis denominator · Participants

GroupSource count
Alectinib62
Crizotinib47
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 48

Analysis denominator · Participants

GroupSource count
Alectinib67
Crizotinib47
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 52

Analysis denominator · Participants

GroupSource count
Alectinib58
Crizotinib44
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.033.3Not reported
Treatment - week 56

Analysis denominator · Participants

GroupSource count
Alectinib61
Crizotinib48
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.0100.0Not reported
Treatment - week 60

Analysis denominator · Participants

GroupSource count
Alectinib47
Crizotinib39
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 64

Analysis denominator · Participants

GroupSource count
Alectinib55
Crizotinib39
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 68

Analysis denominator · Participants

GroupSource count
Alectinib49
Crizotinib34
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 72

Analysis denominator · Participants

GroupSource count
Alectinib54
Crizotinib34
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 76

Analysis denominator · Participants

GroupSource count
Alectinib42
Crizotinib29
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 80

Analysis denominator · Participants

GroupSource count
Alectinib43
Crizotinib23
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib0.0Not reported0.033.33Not reported
Treatment - week 84

Analysis denominator · Participants

GroupSource count
Alectinib33
Crizotinib19
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.033.33Not reported
Treatment - week 88

Analysis denominator · Participants

GroupSource count
Alectinib36
Crizotinib16
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.033.33Not reported
Treatment - week 92

Analysis denominator · Participants

GroupSource count
Alectinib30
Crizotinib13
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.066.7Not reported
Crizotinib0.0Not reported0.066.7Not reported
Treatment - week 96

Analysis denominator · Participants

GroupSource count
Alectinib22
Crizotinib11
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib16.67Not reported0.066.7Not reported
Crizotinib0.0Not reported0.033.33Not reported
Treatment - week 100

Analysis denominator · Participants

GroupSource count
Alectinib18
Crizotinib10
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib0.0Not reported0.0100.0Not reported
Crizotinib0.0Not reported0.033.3Not reported
Treatment - week 104

Analysis denominator · Participants

GroupSource count
Alectinib15
Crizotinib7
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib0.0Not reported0.033.3Not reported
Treatment - week 108

Analysis denominator · Participants

GroupSource count
Alectinib11
Crizotinib7
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.066.7Not reported
Crizotinib33.33Not reported0.033.33Not reported
Treatment - week 112

Analysis denominator · Participants

GroupSource count
Alectinib9
Crizotinib4
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.033.33Not reported
Crizotinib0.0Not reported0.033.33Not reported
Treatment - week 116

Analysis denominator · Participants

GroupSource count
Alectinib4
Crizotinib2
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported0.033.33Not reported
Crizotinib16.67Not reported0.033.33Not reported
Treatment - week 120

Analysis denominator · Participants

GroupSource count
Alectinib3
Crizotinib0
Values in Score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib33.33Not reported33.3333.33Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        96
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        89
      units
      Participants
    title
    Treatment - week 4
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        66.7
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        84
      units
      Participants
    title
    Treatment - week 8
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        78
      units
      Participants
    title
    Treatment - week 12
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        73
      units
      Participants
    title
    Treatment - week 16
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Treatment - week 20
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        71
      units
      Participants
    title
    Treatment - week 24
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        100.0
        value
        16.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Treatment - week 28
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        100.0
        value
        33.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        65
      units
      Participants
    title
    Treatment - week 32
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        100.0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        61
      units
      Participants
    title
    Treatment - week 36
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        66.7
        value
        33.33
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        50
      units
      Participants
    title
    Treatment - week 40
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        66.7
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Treatment - week 44
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      151
    units
    Participants
description
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
dispersion Type
Full Range
groups
  1. description
    Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG000
    title
    Alectinib
  2. description
    Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG001
    title
    Crizotinib
param Type
MEDIAN
population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.
reporting Status
POSTED
time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
title
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing
type
SECONDARY
unit Of Measure
Score on a scale

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Preserved source evidence · Not medical advice