NCT02737501 · BASELINE

Baseline characteristics

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants · Source last updated 2021-08-20

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

denoms

counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants

groups

description
Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
id
BG000
title
Randomized Phase: Brigatinib 90 mg QD/180 QD
description
Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
id
BG001
title
Randomized Phase: Crizotinib 250 mg BID
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.46
value
57.9
group Id
BG001
spread
11.42
value
58.6
group Id
BG002
spread
12.46
value
58.2
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
69
group Id
BG001
value
81
group Id
BG002
value
150
title
Female
measurements
group Id
BG000
value
68
group Id
BG001
value
57
group Id
BG002
value
125
title
Male
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
59
group Id
BG001
value
49
group Id
BG002
value
108
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Black or African American
measurements
group Id
BG000
value
76
group Id
BG001
value
86
group Id
BG002
value
162
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
10
group Id
BG002
value
16
title
Hispanic, Latino or Spanish
measurements
group Id
BG000
value
131
group Id
BG001
value
128
group Id
BG002
value
259
title
Not Hispanic, Latino or Spanish
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
6
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Hong Kong
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Singapore
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
28
group Id
BG002
value
57
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Korea, Republic Of
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
9
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Taiwan, Province Of China
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
France
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
11
group Id
BG002
value
17
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
19
group Id
BG002
value
38
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Luxembourg
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Netherlands
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
0.00
upper Limit
100.00
value
60.432
group Id
BG001
lower Limit
0.00
upper Limit
100.00
value
59.160
group Id
BG002
lower Limit
0.00
upper Limit
100.00
value
59.796
denoms
counts
group Id
BG000
value
131
group Id
BG001
value
131
group Id
BG002
value
262
units
Participants
description
HRQoL:perceived quality of participant's life,includes self-reported multidimensional measures of physical,mental health.EORTC-QLQ-C30 contains 30 items across 5 functional scales(physical,role,cognitive,emotional,social),9 symptom scales(fatigue,nausea and vomiting,pain,dyspnea,sleep disturbance,appetite loss,constipation,diarrhea,financial difficulties),a global health status/QOL scale on 4 response levels(not at all,a little,quite a bit,very much),with 2 questions relying on a 7-point numeric rating scale.Raw scores converted into overall score of 0-100,lower scores indicate better QOL.
dispersion Type
FULL_RANGE
param Type
MEAN
population Description
Number analyzed is number of participants with data available for global health status/QoL at Baseline.
title
Global Health Status/Quality of Life (QoL)
unit Of Measure
score on a scale

population Description

Intent-to-treat (ITT) Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.

Complete source fields

denoms

counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants

groups

description
Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
id
BG000
title
Randomized Phase: Brigatinib 90 mg QD/180 QD
description
Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
id
BG001
title
Randomized Phase: Crizotinib 250 mg BID
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.46
value
57.9
group Id
BG001
spread
11.42
value
58.6
group Id
BG002
spread
12.46
value
58.2
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
69
group Id
BG001
value
81
group Id
BG002
value
150
title
Female
measurements
group Id
BG000
value
68
group Id
BG001
value
57
group Id
BG002
value
125
title
Male
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
59
group Id
BG001
value
49
group Id
BG002
value
108
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Black or African American
measurements
group Id
BG000
value
76
group Id
BG001
value
86
group Id
BG002
value
162
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
10
group Id
BG002
value
16
title
Hispanic, Latino or Spanish
measurements
group Id
BG000
value
131
group Id
BG001
value
128
group Id
BG002
value
259
title
Not Hispanic, Latino or Spanish
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
6
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Hong Kong
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Singapore
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
28
group Id
BG002
value
57
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Korea, Republic Of
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
9
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Taiwan, Province Of China
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
France
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
11
group Id
BG002
value
17
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
19
group Id
BG002
value
38
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Luxembourg
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
275
units
Participants
title
Netherlands
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
0.00
upper Limit
100.00
value
60.432
group Id
BG001
lower Limit
0.00
upper Limit
100.00
value
59.160
group Id
BG002
lower Limit
0.00
upper Limit
100.00
value
59.796
denoms
counts
group Id
BG000
value
131
group Id
BG001
value
131
group Id
BG002
value
262
units
Participants
description
HRQoL:perceived quality of participant's life,includes self-reported multidimensional measures of physical,mental health.EORTC-QLQ-C30 contains 30 items across 5 functional scales(physical,role,cognitive,emotional,social),9 symptom scales(fatigue,nausea and vomiting,pain,dyspnea,sleep disturbance,appetite loss,constipation,diarrhea,financial difficulties),a global health status/QOL scale on 4 response levels(not at all,a little,quite a bit,very much),with 2 questions relying on a 7-point numeric rating scale.Raw scores converted into overall score of 0-100,lower scores indicate better QOL.
dispersion Type
FULL_RANGE
param Type
MEAN
population Description
Number analyzed is number of participants with data available for global health status/QoL at Baseline.
title
Global Health Status/Quality of Life (QoL)
unit Of Measure
score on a scale

population Description

Intent-to-treat (ITT) Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.

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Preserved source evidence · Not medical advice