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NCT02075840 · OUTCOME

Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score

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-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. 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

Group	Source count
Alectinib	152
Crizotinib	151

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Alectinib	100
Crizotinib	97

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	8.3	100.0	Not reported
Crizotinib	66.67	Not reported	0.0	100.0	Not reported

Treatment - week 4

Analysis denominator · Participants

Group	Source count
Alectinib	95
Crizotinib	89

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	0.0	100.0	Not reported
Crizotinib	66.67	Not reported	16.7	100.0	Not reported

Treatment - week 8

Analysis denominator · Participants

Group	Source count
Alectinib	89
Crizotinib	84

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	16.7	100.0	Not reported
Crizotinib	75.0	Not reported	16.7	100.0	Not reported

Treatment - week 12

Analysis denominator · Participants

Group	Source count
Alectinib	75
Crizotinib	78

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	25.0	100.0	Not reported
Crizotinib	75.0	Not reported	33.3	100.0	Not reported

Treatment - week 16

Analysis denominator · Participants

Group	Source count
Alectinib	79
Crizotinib	73

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	16.7	100.0	Not reported
Crizotinib	83.33	Not reported	16.7	100.0	Not reported

Treatment - week 20

Analysis denominator · Participants

Group	Source count
Alectinib	73
Crizotinib	67

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	16.7	100.0	Not reported
Crizotinib	75.0	Not reported	16.7	100.0	Not reported

Treatment - week 24

Analysis denominator · Participants

Group	Source count
Alectinib	77
Crizotinib	71

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	16.7	100.0	Not reported
Crizotinib	83.33	Not reported	8.3	100.0	Not reported

Treatment - week 28

Analysis denominator · Participants

Group	Source count
Alectinib	67
Crizotinib	62

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	75.0	Not reported	33.3	100.0	Not reported

Treatment - week 32

Analysis denominator · Participants

Group	Source count
Alectinib	73
Crizotinib	65

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	66.67	Not reported	8.3	100.0	Not reported

Treatment - week 36

Analysis denominator · Participants

Group	Source count
Alectinib	64
Crizotinib	61

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	79.17	Not reported	16.7	100.0	Not reported
Crizotinib	66.67	Not reported	16.7	100.0	Not reported

Treatment - week 40

Analysis denominator · Participants

Group	Source count
Alectinib	74
Crizotinib	50

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	16.7	100.0	Not reported
Crizotinib	83.33	Not reported	33.3	100.0	Not reported

Treatment - week 44

Analysis denominator · Participants

Group	Source count
Alectinib	62
Crizotinib	47

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	83.33	Not reported	16.7	100.0	Not reported
Crizotinib	83.33	Not reported	16.7	100.0	Not reported

Treatment - week 48

Analysis denominator · Participants

Group	Source count
Alectinib	67
Crizotinib	47

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	25.0	100.0	Not reported
Crizotinib	83.33	Not reported	41.7	100.0	Not reported

Treatment - week 52

Analysis denominator · Participants

Group	Source count
Alectinib	58
Crizotinib	44

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	83.33	Not reported	16.7	100.0	Not reported
Crizotinib	75.00	Not reported	41.7	100.0	Not reported

Treatment - week 56

Analysis denominator · Participants

Group	Source count
Alectinib	61
Crizotinib	48

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	16.7	100.0	Not reported
Crizotinib	75.0	Not reported	41.7	100.0	Not reported

Treatment - week 60

Analysis denominator · Participants

Group	Source count
Alectinib	47
Crizotinib	39

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	75.0	Not reported	50.0	100.0	Not reported

Treatment - week 64

Analysis denominator · Participants

Group	Source count
Alectinib	55
Crizotinib	39

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	83.33	Not reported	41.7	100.0	Not reported

Treatment - week 68

Analysis denominator · Participants

Group	Source count
Alectinib	49
Crizotinib	34

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	79.17	Not reported	33.3	100.0	Not reported

Treatment - week 72

Analysis denominator · Participants

Group	Source count
Alectinib	54
Crizotinib	34

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	75.00	Not reported	8.3	100.0	Not reported

Treatment - week 76

Analysis denominator · Participants

Group	Source count
Alectinib	42
Crizotinib	29

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	41.7	100.0	Not reported
Crizotinib	75.0	Not reported	16.7	100.0	Not reported

Treatment - week 80

Analysis denominator · Participants

Group	Source count
Alectinib	43
Crizotinib	23

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	75.0	Not reported	33.3	100.0	Not reported

Treatment - week 84

Analysis denominator · Participants

Group	Source count
Alectinib	33
Crizotinib	19

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	83.33	Not reported	41.7	100.0	Not reported
Crizotinib	66.67	Not reported	33.3	100.0	Not reported

Treatment - week 88

Analysis denominator · Participants

Group	Source count
Alectinib	36
Crizotinib	16

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	33.3	100.0	Not reported
Crizotinib	66.67	Not reported	33.3	100.0	Not reported

Treatment - week 92

Analysis denominator · Participants

Group	Source count
Alectinib	30
Crizotinib	13

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	70.83	Not reported	33.3	100.0	Not reported
Crizotinib	75.0	Not reported	50.0	100.0	Not reported

Treatment - week 96

Analysis denominator · Participants

Group	Source count
Alectinib	22
Crizotinib	11

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	33.3	100.0	Not reported
Crizotinib	66.67	Not reported	33.3	100.0	Not reported

Treatment - week 100

Analysis denominator · Participants

Group	Source count
Alectinib	18
Crizotinib	10

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	25.0	100.0	Not reported
Crizotinib	75.0	Not reported	33.3	100.0	Not reported

Treatment - week 104

Analysis denominator · Participants

Group	Source count
Alectinib	15
Crizotinib	7

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	50.0	100.0	Not reported
Crizotinib	66.67	Not reported	50.0	100.0	Not reported

Treatment - week 108

Analysis denominator · Participants

Group	Source count
Alectinib	11
Crizotinib	7

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	66.67	Not reported	50.0	100.0	Not reported
Crizotinib	75.0	Not reported	33.3	100.0	Not reported

Treatment - week 112

Analysis denominator · Participants

Group	Source count
Alectinib	9
Crizotinib	4

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	75.0	Not reported	50.0	100.0	Not reported
Crizotinib	75.0	Not reported	33.3	100.0	Not reported

Treatment - week 116

Analysis denominator · Participants

Group	Source count
Alectinib	4
Crizotinib	2

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	70.83	Not reported	41.7	100.0	Not reported
Crizotinib	91.67	Not reported	83.3	100.0	Not reported

Treatment - week 120

Analysis denominator · Participants

Group	Source count
Alectinib	3
Crizotinib	151

Values in Score on a scale · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Alectinib	83.3	Not reported	50.0	100.0	Not reported
Crizotinib	NA	Not reported	NA	NA	Not evaluable at week 120

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
8.3
upper Limit
100.0
value
66.67
group Id
OG001
lower Limit
0.0
upper Limit
100.0
value
66.67
denoms
counts
group Id
OG000
value
100
group Id
OG001
value
97
units
Participants
title
Baseline
categories
measurements
group Id
OG000
lower Limit
0.0
upper Limit
100.0
value
66.67
group Id
OG001
lower Limit
16.7
upper Limit
100.0
value
66.67
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
89
units
Participants
title
Treatment - week 4
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
16.7
upper Limit
100.0
value
75.0
denoms
counts
group Id
OG000
value
89
group Id
OG001
value
84
units
Participants
title
Treatment - week 8
categories
measurements
group Id
OG000
lower Limit
25.0
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
33.3
upper Limit
100.0
value
75.0
denoms
counts
group Id
OG000
value
75
group Id
OG001
value
78
units
Participants
title
Treatment - week 12
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
16.7
upper Limit
100.0
value
83.33
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
73
units
Participants
title
Treatment - week 16
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
16.7
upper Limit
100.0
value
75.0
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
67
units
Participants
title
Treatment - week 20
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
8.3
upper Limit
100.0
value
83.33
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
71
units
Participants
title
Treatment - week 24
categories
measurements
group Id
OG000
lower Limit
33.3
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
33.3
upper Limit
100.0
value
75.0
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
62
units
Participants
title
Treatment - week 28
categories
measurements
group Id
OG000
lower Limit
33.3
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
8.3
upper Limit
100.0
value
66.67
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
65
units
Participants
title
Treatment - week 32
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
79.17
group Id
OG001
lower Limit
16.7
upper Limit
100.0
value
66.67
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
61
units
Participants
title
Treatment - week 36
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
75.0
group Id
OG001
lower Limit
33.3
upper Limit
100.0
value
83.33
denoms
counts
group Id
OG000
value
74
group Id
OG001
value
50
units
Participants
title
Treatment - week 40
categories
measurements
group Id
OG000
lower Limit
16.7
upper Limit
100.0
value
83.33
group Id
OG001
lower Limit
16.7
upper Limit
100.0
value
83.33
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
47
units
Participants
title
Treatment - week 44

denoms

counts
group Id
OG000
value
152
group Id
OG001
value
151
units
Participants

description

The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. 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

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
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

Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score

type

SECONDARY

unit Of Measure

Score on a scale

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

Preserved source evidence · Not medical advice