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NCT01828099 · OUTCOME

Least Squares Mean Scores on the EORTC-QLQ C30

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

Measure: LEAST_SQUARES_MEAN
Unit: Score on a scale
Interval / dispersion: Standard Error
Time frame: Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months

What was measured

The EORTC QLQ-C30 contained 30 items and was of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status (GHS)/quality of life (QoL) scale. Items were assessed on a 4- or 7-level Likert scale, ranging from 1="very poor" to 7= "excellent" for GHS items and 1= "not at all" to 4= "very much" for all other items. The scores of the scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A high score represented a higher response level. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained

Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the scales/single items

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

Chemotherapy

Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

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
Ceritinib	182
Chemotherapy	161

Reported measurements

Global Health Status/QoL

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	69.4	0.71	Not reported	Not reported	Not reported
Chemotherapy	63.7	0.98	Not reported	Not reported	Not reported

Physical Functioning

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	83.5	0.78	Not reported	Not reported	Not reported
Chemotherapy	77.6	1.07	Not reported	Not reported	Not reported

Emotional Functioning

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	82.3	0.70	Not reported	Not reported	Not reported
Chemotherapy	76.6	0.97	Not reported	Not reported	Not reported

Social Functioning

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	79.0	1.01	Not reported	Not reported	Not reported
Chemotherapy	75.4	1.38	Not reported	Not reported	Not reported

Cognitive Functioning

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	86.7	0.68	Not reported	Not reported	Not reported
Chemotherapy	84.0	0.94	Not reported	Not reported	Not reported

Role Functioning

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	79.5	1.03	Not reported	Not reported	Not reported
Chemotherapy	71.3	1.44	Not reported	Not reported	Not reported

Fatigue

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	25.9	0.84	Not reported	Not reported	Not reported
Chemotherapy	31.4	1.17	Not reported	Not reported	Not reported

Nausea and Vomiting

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	11.8	0.58	Not reported	Not reported	Not reported
Chemotherapy	11.6	0.82	Not reported	Not reported	Not reported

Pain

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	14.7	0.75	Not reported	Not reported	Not reported
Chemotherapy	16.9	1.05	Not reported	Not reported	Not reported

Dyspnea

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	15.0	0.75	Not reported	Not reported	Not reported
Chemotherapy	22.1	1.05	Not reported	Not reported	Not reported

Insomnia

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	14.8	0.78	Not reported	Not reported	Not reported
Chemotherapy	21.1	1.09	Not reported	Not reported	Not reported

Appetite Loss

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	15.9	0.82	Not reported	Not reported	Not reported
Chemotherapy	19.3	1.15	Not reported	Not reported	Not reported

Constipation

Analysis denominator · Participants

Group	Source count
Ceritinib	182
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	8.1	0.60	Not reported	Not reported	Not reported
Chemotherapy	13.0	0.84	Not reported	Not reported	Not reported

Diarrhea

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	161

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	25.7	0.80	Not reported	Not reported	Not reported
Chemotherapy	4.6	1.12	Not reported	Not reported	Not reported

Financial Difficulties

Analysis denominator · Participants

Group	Source count
Ceritinib	181
Chemotherapy	160

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Ceritinib	19.9	1.19	Not reported	Not reported	Not reported
Chemotherapy	23.8	1.63	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.71
value
69.4
group Id
OG001
spread
0.98
value
63.7
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
161
units
Participants
title
Global Health Status/QoL
categories
measurements
group Id
OG000
spread
0.78
value
83.5
group Id
OG001
spread
1.07
value
77.6
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Physical Functioning
categories
measurements
group Id
OG000
spread
0.70
value
82.3
group Id
OG001
spread
0.97
value
76.6
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
161
units
Participants
title
Emotional Functioning
categories
measurements
group Id
OG000
spread
1.01
value
79.0
group Id
OG001
spread
1.38
value
75.4
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
161
units
Participants
title
Social Functioning
categories
measurements
group Id
OG000
spread
0.68
value
86.7
group Id
OG001
spread
0.94
value
84.0
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
161
units
Participants
title
Cognitive Functioning
categories
measurements
group Id
OG000
spread
1.03
value
79.5
group Id
OG001
spread
1.44
value
71.3
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Role Functioning
categories
measurements
group Id
OG000
spread
0.84
value
25.9
group Id
OG001
spread
1.17
value
31.4
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Fatigue
categories
measurements
group Id
OG000
spread
0.58
value
11.8
group Id
OG001
spread
0.82
value
11.6
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Nausea and Vomiting
categories
measurements
group Id
OG000
spread
0.75
value
14.7
group Id
OG001
spread
1.05
value
16.9
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
161
units
Participants
title
Pain
categories
measurements
group Id
OG000
spread
0.75
value
15.0
group Id
OG001
spread
1.05
value
22.1
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Dyspnea
categories
measurements
group Id
OG000
spread
0.78
value
14.8
group Id
OG001
spread
1.09
value
21.1
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Insomnia
categories
measurements
group Id
OG000
spread
0.82
value
15.9
group Id
OG001
spread
1.15
value
19.3
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants
title
Appetite Loss

denoms

counts
group Id
OG000
value
182
group Id
OG001
value
161
units
Participants

description

The EORTC QLQ-C30 contained 30 items and was of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status (GHS)/quality of life (QoL) scale. Items were assessed on a 4- or 7-level Likert scale, ranging from 1="very poor" to 7= "excellent" for GHS items and 1= "not at all" to 4= "very much" for all other items. The scores of the scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A high score represented a higher response level. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained

dispersion Type

Standard Error

groups

description
Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
id
OG000
title
Ceritinib
description
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
id
OG001
title
Chemotherapy

param Type

LEAST_SQUARES_MEAN

population Description

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the scales/single items

reporting Status

POSTED

time Frame

Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months

title

Least Squares Mean Scores on the EORTC-QLQ C30

type

SECONDARY

unit Of Measure

Score on a scale

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

Preserved source evidence · Not medical advice