NCT02614794 · BASELINE

Baseline characteristics

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer · Source last updated 2023-08-14

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

denoms

counts
group Id
BG000
value
410
group Id
BG001
value
202
group Id
BG002
value
612
units
Participants

groups

description
Tucatinib in combination with capecitabine \& trastuzumab
id
BG000
title
Tuc+Cap+Tra
description
Placebo in combination with capecitabine \& trastuzumab
id
BG001
title
Pbo+Cap+Tra
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
328
group Id
BG001
value
168
group Id
BG002
value
496
title
Between 18 and 65 years
measurements
group Id
BG000
value
82
group Id
BG001
value
34
group Id
BG002
value
116
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
22
upper Limit
80
value
55
group Id
BG001
lower Limit
25
upper Limit
82
value
54
group Id
BG002
lower Limit
22
upper Limit
82
value
54
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
407
group Id
BG001
value
200
group Id
BG002
value
607
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
14
group Id
BG002
value
51
title
Hispanic or Latino
measurements
group Id
BG000
value
362
group Id
BG001
value
184
group Id
BG002
value
546
title
Not Hispanic or Latino
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
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
18
group Id
BG001
value
5
group Id
BG002
value
23
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
41
group Id
BG001
value
14
group Id
BG002
value
55
title
Black or African American
measurements
group Id
BG000
value
287
group Id
BG001
value
157
group Id
BG002
value
444
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
64
group Id
BG001
value
26
group Id
BG002
value
90
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
220
group Id
BG001
value
111
group Id
BG002
value
331
title
United States
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
17
group Id
BG002
value
46
title
France
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
12
group Id
BG002
value
45
title
United Kingdom
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
12
group Id
BG002
value
39
title
Australia
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
12
group Id
BG002
value
38
title
Canada
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
7
group Id
BG002
value
26
title
Spain
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
7
group Id
BG002
value
20
title
Denmark
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
8
group Id
BG002
value
17
title
Germany
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
3
group Id
BG002
value
16
title
Israel
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Belgium
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
3
group Id
BG002
value
9
title
Italy
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
1
group Id
BG002
value
7
title
Austria
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
204
group Id
BG001
value
94
group Id
BG002
value
298
title
0: Normal activity
measurements
group Id
BG000
value
206
group Id
BG001
value
108
group Id
BG002
value
314
title
1: Symptoms, but ambulatory
description
0=Normal activity; 1=Symptoms but ambulatory; 2=In bed \<50% of the time; 3= In bed \>50% of the time; 4=100% bedridden; 5=Dead
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants

population Description

Intent-to-treat Overall Survival (ITT-OS) Population: Includes all randomized participants evaluated by their randomized treatment assignment.

Complete source fields

denoms

counts
group Id
BG000
value
410
group Id
BG001
value
202
group Id
BG002
value
612
units
Participants

groups

description
Tucatinib in combination with capecitabine \& trastuzumab
id
BG000
title
Tuc+Cap+Tra
description
Placebo in combination with capecitabine \& trastuzumab
id
BG001
title
Pbo+Cap+Tra
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
328
group Id
BG001
value
168
group Id
BG002
value
496
title
Between 18 and 65 years
measurements
group Id
BG000
value
82
group Id
BG001
value
34
group Id
BG002
value
116
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
22
upper Limit
80
value
55
group Id
BG001
lower Limit
25
upper Limit
82
value
54
group Id
BG002
lower Limit
22
upper Limit
82
value
54
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
407
group Id
BG001
value
200
group Id
BG002
value
607
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
14
group Id
BG002
value
51
title
Hispanic or Latino
measurements
group Id
BG000
value
362
group Id
BG001
value
184
group Id
BG002
value
546
title
Not Hispanic or Latino
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
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
18
group Id
BG001
value
5
group Id
BG002
value
23
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
41
group Id
BG001
value
14
group Id
BG002
value
55
title
Black or African American
measurements
group Id
BG000
value
287
group Id
BG001
value
157
group Id
BG002
value
444
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
64
group Id
BG001
value
26
group Id
BG002
value
90
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
220
group Id
BG001
value
111
group Id
BG002
value
331
title
United States
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
17
group Id
BG002
value
46
title
France
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
12
group Id
BG002
value
45
title
United Kingdom
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
12
group Id
BG002
value
39
title
Australia
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
12
group Id
BG002
value
38
title
Canada
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
7
group Id
BG002
value
26
title
Spain
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
7
group Id
BG002
value
20
title
Denmark
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
8
group Id
BG002
value
17
title
Germany
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
3
group Id
BG002
value
16
title
Israel
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Belgium
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
3
group Id
BG002
value
9
title
Italy
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
1
group Id
BG002
value
7
title
Austria
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
204
group Id
BG001
value
94
group Id
BG002
value
298
title
0: Normal activity
measurements
group Id
BG000
value
206
group Id
BG001
value
108
group Id
BG002
value
314
title
1: Symptoms, but ambulatory
description
0=Normal activity; 1=Symptoms but ambulatory; 2=In bed \<50% of the time; 3= In bed \>50% of the time; 4=100% bedridden; 5=Dead
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants

population Description

Intent-to-treat Overall Survival (ITT-OS) Population: Includes all randomized participants evaluated by their randomized treatment assignment.

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

Preserved source evidence · Not medical advice