NCT00932893 · OUTCOME

European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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

Measure: MEAN
Unit: units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

What was measured

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Analysis population: FAS included all participants who were randomized to study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time points for each arm group, respectively.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

Chemotherapy

Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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
Crizotinib	164
Chemotherapy	161

Reported measurements

Baseline (n=164, 161)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	64.09	21.04	Not reported	Not reported	Not reported
Chemotherapy	66.76	20.74	Not reported	Not reported	Not reported

C2D1 (n=153, 131)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	69.19	19.42	Not reported	Not reported	Not reported
Chemotherapy	66.33	20.30	Not reported	Not reported	Not reported

C3D1 (n=153, 105)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	73.13	18.97	Not reported	Not reported	Not reported
Chemotherapy	65.84	20.80	Not reported	Not reported	Not reported

C4D1 (n=135, 90)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	73.78	18.25	Not reported	Not reported	Not reported
Chemotherapy	69.13	18.14	Not reported	Not reported	Not reported

C5D1 (n=122, 74)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.27	17.99	Not reported	Not reported	Not reported
Chemotherapy	68.12	23.19	Not reported	Not reported	Not reported

C6D1 (n=120, 70)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.79	18.67	Not reported	Not reported	Not reported
Chemotherapy	69.71	22.46	Not reported	Not reported	Not reported

C7D1 (n=115, 52)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	77.02	17.34	Not reported	Not reported	Not reported
Chemotherapy	70.63	24.31	Not reported	Not reported	Not reported

C8D1 (n=110, 43)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	74.72	18.09	Not reported	Not reported	Not reported
Chemotherapy	72.30	23.54	Not reported	Not reported	Not reported

C9D1 (n=101, 37)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	74.45	18.32	Not reported	Not reported	Not reported
Chemotherapy	72.27	25.85	Not reported	Not reported	Not reported

C10D1 (n=94, 33)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.49	18.18	Not reported	Not reported	Not reported
Chemotherapy	74.27	24.88	Not reported	Not reported	Not reported

C11D1 (n=84, 25)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	76.32	17.00	Not reported	Not reported	Not reported
Chemotherapy	77.24	20.31	Not reported	Not reported	Not reported

C12D1 (n=77, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	76.95	17.63	Not reported	Not reported	Not reported
Chemotherapy	74.83	22.60	Not reported	Not reported	Not reported

C13D1 (n=73, 21)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	76.38	17.50	Not reported	Not reported	Not reported
Chemotherapy	73.00	23.54	Not reported	Not reported	Not reported

C14D1 (n=66, 19)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	78.77	15.54	Not reported	Not reported	Not reported
Chemotherapy	74.11	22.56	Not reported	Not reported	Not reported

C15D1 (n=62, 16)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	77.71	16.78	Not reported	Not reported	Not reported
Chemotherapy	77.44	19.52	Not reported	Not reported	Not reported

C16D1 (n=53, 12)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.32	16.21	Not reported	Not reported	Not reported
Chemotherapy	79.00	13.28	Not reported	Not reported	Not reported

C17D1 (n=47, 11)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.09	17.68	Not reported	Not reported	Not reported
Chemotherapy	81.73	15.98	Not reported	Not reported	Not reported

C18D1 (n=45, 11)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.87	16.63	Not reported	Not reported	Not reported
Chemotherapy	78.91	16.25	Not reported	Not reported	Not reported

C19D1 (n=40, 9)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	76.85	16.39	Not reported	Not reported	Not reported
Chemotherapy	78.00	14.04	Not reported	Not reported	Not reported

C20D1 (n=35, 8)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	72.66	19.81	Not reported	Not reported	Not reported
Chemotherapy	76.75	17.65	Not reported	Not reported	Not reported

C21D1 (n=30, 8)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	74.13	16.19	Not reported	Not reported	Not reported
Chemotherapy	73.63	19.41	Not reported	Not reported	Not reported

C22D1 (n=24, 7)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	77.54	17.54	Not reported	Not reported	Not reported
Chemotherapy	72.21	19.79	Not reported	Not reported	Not reported

C23D1 (n=23, 4)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.48	17.75	Not reported	Not reported	Not reported
Chemotherapy	54.00	16.35	Not reported	Not reported	Not reported

C24D1 (n=20, 3)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	71.40	23.15	Not reported	Not reported	Not reported
Chemotherapy	62.00	20.30	Not reported	Not reported	Not reported

C25D1 (n=18, 3)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	75.61	15.97	Not reported	Not reported	Not reported
Chemotherapy	63.67	22.59	Not reported	Not reported	Not reported

C26D1 (n=14, 3)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	72.14	20.71	Not reported	Not reported	Not reported
Chemotherapy	63.00	17.52	Not reported	Not reported	Not reported

C27D1 (n=14, 2)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	66.57	16.96	Not reported	Not reported	Not reported
Chemotherapy	50.00	14.14	Not reported	Not reported	Not reported

C28D1 (n=11, 2)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	72.36	12.72	Not reported	Not reported	Not reported
Chemotherapy	55.00	21.21	Not reported	Not reported	Not reported

C29D1 (n=8, 2)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	71.38	12.28	Not reported	Not reported	Not reported
Chemotherapy	45.00	14.14	Not reported	Not reported	Not reported

C30D1 (n=8, 1)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	69.50	17.00	Not reported	Not reported	Not reported
Chemotherapy	40.00	NA	Not reported	Not reported	Standard deviation was not estimable since only one participant was evaluable

C31D1 (n=7, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	68.57	16.76	Not reported	Not reported	Not reported
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

C32D1 (n=6, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	65.83	19.41	Not reported	Not reported	Not reported
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

C33D1 (n=6, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	67.50	20.34	Not reported	Not reported	Not reported
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

C34D1 (n=5, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	68.00	20.80	Not reported	Not reported	Not reported
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

C35D1 (n=4, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	72.25	14.84	Not reported	Not reported	Not reported
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

C36D1 (n=1, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	90.00	NA	Not reported	Not reported	Standard deviation was not estimable since only one participant was evaluable
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

C37D1 (n=1, 0)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	85.00	NA	Not reported	Not reported	Standard deviation was not estimable since only one participant was evaluable
Chemotherapy	NA	NA	Not reported	Not reported	Data was not analyzed as no participants were evaluable

EOT (n=49, 90)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	68.33	21.25	Not reported	Not reported	Not reported
Chemotherapy	58.34	23.71	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
21.04
value
64.09
group Id
OG001
spread
20.74
value
66.76
title
Baseline (n=164, 161)
categories
measurements
group Id
OG000
spread
19.42
value
69.19
group Id
OG001
spread
20.30
value
66.33
title
C2D1 (n=153, 131)
categories
measurements
group Id
OG000
spread
18.97
value
73.13
group Id
OG001
spread
20.80
value
65.84
title
C3D1 (n=153, 105)
categories
measurements
group Id
OG000
spread
18.25
value
73.78
group Id
OG001
spread
18.14
value
69.13
title
C4D1 (n=135, 90)
categories
measurements
group Id
OG000
spread
17.99
value
75.27
group Id
OG001
spread
23.19
value
68.12
title
C5D1 (n=122, 74)
categories
measurements
group Id
OG000
spread
18.67
value
75.79
group Id
OG001
spread
22.46
value
69.71
title
C6D1 (n=120, 70)
categories
measurements
group Id
OG000
spread
17.34
value
77.02
group Id
OG001
spread
24.31
value
70.63
title
C7D1 (n=115, 52)
categories
measurements
group Id
OG000
spread
18.09
value
74.72
group Id
OG001
spread
23.54
value
72.30
title
C8D1 (n=110, 43)
categories
measurements
group Id
OG000
spread
18.32
value
74.45
group Id
OG001
spread
25.85
value
72.27
title
C9D1 (n=101, 37)
categories
measurements
group Id
OG000
spread
18.18
value
75.49
group Id
OG001
spread
24.88
value
74.27
title
C10D1 (n=94, 33)
categories
measurements
group Id
OG000
spread
17.00
value
76.32
group Id
OG001
spread
20.31
value
77.24
title
C11D1 (n=84, 25)
categories
measurements
group Id
OG000
spread
17.63
value
76.95
group Id
OG001
spread
22.60
value
74.83
title
C12D1 (n=77, 23)

denoms

counts
group Id
OG000
value
164
group Id
OG001
value
161
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
id
OG000
title
Crizotinib
description
Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
id
OG001
title
Chemotherapy

param Type

MEAN

population Description

FAS included all participants who were randomized to study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time points for each arm group, respectively.

reporting Status

POSTED

time Frame

Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

title

European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice