NCT01808573 · BASELINE

Baseline characteristics

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting · Source last updated 2021-06-11

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

denoms

counts
group Id
BG000
value
307
group Id
BG001
value
314
group Id
BG002
value
621
units
Participants

groups

description
neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
id
BG000
title
Neratinib Plus Capecitabine
description
lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
id
BG001
title
Lapatinib Plus Capecitabine
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.37
value
55.04
group Id
BG001
spread
11.36
value
54.32
group Id
BG002
spread
11.36
value
54.67
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
307
group Id
BG001
value
311
group Id
BG002
value
618
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
42
group Id
BG002
value
82
title
Hispanic or Latino
measurements
group Id
BG000
value
256
group Id
BG001
value
259
group Id
BG002
value
515
title
Not Hispanic or Latino
measurements
group Id
BG000
value
11
group Id
BG001
value
13
group Id
BG002
value
24
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
109
group Id
BG001
value
105
group Id
BG002
value
214
title
Asian
measurements
group Id
BG000
value
9
group Id
BG001
value
15
group Id
BG002
value
24
title
Black or African American
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
178
group Id
BG001
value
177
group Id
BG002
value
355
title
White
measurements
group Id
BG000
value
7
group Id
BG001
value
10
group Id
BG002
value
17
title
Other
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Unknown/Missing
title
Race
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
215
group Id
BG001
value
215
group Id
BG002
value
430
title
2
measurements
group Id
BG000
value
92
group Id
BG001
value
99
group Id
BG002
value
191
title
>=3
param Type
COUNT_OF_PARTICIPANTS
title
Previous HER2 Regimens
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
60
group Id
BG001
value
61
group Id
BG002
value
121
title
Non Visceral
measurements
group Id
BG000
value
247
group Id
BG001
value
253
group Id
BG002
value
500
title
Visceral
param Type
COUNT_OF_PARTICIPANTS
title
Disease Location
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
126
group Id
BG001
value
128
group Id
BG002
value
254
title
Negative
measurements
group Id
BG000
value
181
group Id
BG001
value
186
group Id
BG002
value
367
title
Positive
param Type
COUNT_OF_PARTICIPANTS
title
Hormone Receptor Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
121
group Id
BG001
value
123
group Id
BG002
value
244
title
Europe
measurements
group Id
BG000
value
59
group Id
BG001
value
65
group Id
BG002
value
124
title
North America
measurements
group Id
BG000
value
127
group Id
BG001
value
126
group Id
BG002
value
253
title
Rest of World
param Type
COUNT_OF_PARTICIPANTS
title
Geographic Region
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
307
group Id
BG001
value
314
group Id
BG002
value
621
units
Participants

groups

description
neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
id
BG000
title
Neratinib Plus Capecitabine
description
lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
id
BG001
title
Lapatinib Plus Capecitabine
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.37
value
55.04
group Id
BG001
spread
11.36
value
54.32
group Id
BG002
spread
11.36
value
54.67
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
307
group Id
BG001
value
311
group Id
BG002
value
618
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
42
group Id
BG002
value
82
title
Hispanic or Latino
measurements
group Id
BG000
value
256
group Id
BG001
value
259
group Id
BG002
value
515
title
Not Hispanic or Latino
measurements
group Id
BG000
value
11
group Id
BG001
value
13
group Id
BG002
value
24
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
109
group Id
BG001
value
105
group Id
BG002
value
214
title
Asian
measurements
group Id
BG000
value
9
group Id
BG001
value
15
group Id
BG002
value
24
title
Black or African American
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
178
group Id
BG001
value
177
group Id
BG002
value
355
title
White
measurements
group Id
BG000
value
7
group Id
BG001
value
10
group Id
BG002
value
17
title
Other
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Unknown/Missing
title
Race
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
215
group Id
BG001
value
215
group Id
BG002
value
430
title
2
measurements
group Id
BG000
value
92
group Id
BG001
value
99
group Id
BG002
value
191
title
>=3
param Type
COUNT_OF_PARTICIPANTS
title
Previous HER2 Regimens
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
60
group Id
BG001
value
61
group Id
BG002
value
121
title
Non Visceral
measurements
group Id
BG000
value
247
group Id
BG001
value
253
group Id
BG002
value
500
title
Visceral
param Type
COUNT_OF_PARTICIPANTS
title
Disease Location
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
126
group Id
BG001
value
128
group Id
BG002
value
254
title
Negative
measurements
group Id
BG000
value
181
group Id
BG001
value
186
group Id
BG002
value
367
title
Positive
param Type
COUNT_OF_PARTICIPANTS
title
Hormone Receptor Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
121
group Id
BG001
value
123
group Id
BG002
value
244
title
Europe
measurements
group Id
BG000
value
59
group Id
BG001
value
65
group Id
BG002
value
124
title
North America
measurements
group Id
BG000
value
127
group Id
BG001
value
126
group Id
BG002
value
253
title
Rest of World
param Type
COUNT_OF_PARTICIPANTS
title
Geographic Region
unit Of Measure
Participants

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Preserved source evidence · Not medical advice