NCT00075764 · BASELINE

Baseline characteristics

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer · Source last updated 2021-01-13

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

denoms

counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants

groups

description
Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
id
BG000
title
Arm I Anastrozole
description
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly
id
BG001
title
Arm II Anastrozole and Fulvestrant
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
36
upper Limit
91
value
65
group Id
BG001
lower Limit
27
upper Limit
92
value
65
group Id
BG002
lower Limit
27
upper Limit
92
value
65
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
141
group Id
BG002
value
280
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
206
group Id
BG001
value
208
group Id
BG002
value
414
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
No
param Type
NUMBER
title
Prior adjuvant tamoxifen
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
129
group Id
BG002
value
232
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
242
group Id
BG001
value
220
group Id
BG002
value
462
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
No
param Type
NUMBER
title
Prior adjuvant chemotherapy
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
188
group Id
BG001
value
188
group Id
BG002
value
376
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
157
group Id
BG001
value
161
group Id
BG002
value
318
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
No
param Type
NUMBER
title
Measurable disease
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
75
group Id
BG002
value
151
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Bone only
categories
measurements
group Id
BG000
value
167
group Id
BG001
value
181
group Id
BG002
value
348
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Visceral
categories
measurements
group Id
BG000
value
102
group Id
BG001
value
93
group Id
BG002
value
195
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Nonvisceral
param Type
NUMBER
title
Disease site
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
141
group Id
BG001
value
122
group Id
BG002
value
263
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
None
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
47
group Id
BG002
value
87
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
3 mo to < 5 yr
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
66
group Id
BG002
value
134
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
5 to < 10 yr
categories
measurements
group Id
BG000
value
88
group Id
BG001
value
104
group Id
BG002
value
192
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
>= 10 yr
param Type
NUMBER
population Description
Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
title
Time between diagnosis of primary and metastatic disease
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
31
group Id
BG002
value
56
denoms
counts
group Id
BG000
value
295
group Id
BG001
value
297
group Id
BG002
value
592
units
Participants
title
Positive
categories
measurements
group Id
BG000
value
270
group Id
BG001
value
266
group Id
BG002
value
536
denoms
counts
group Id
BG000
value
295
group Id
BG001
value
297
group Id
BG002
value
592
units
Participants
title
Negative
description
HER2 denotes human epidermal growth factor receptor type 2.
param Type
NUMBER
population Description
Only patients with available HER2 status data will be included in the analysis.
title
HER2 status
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants

groups

description
Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
id
BG000
title
Arm I Anastrozole
description
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly
id
BG001
title
Arm II Anastrozole and Fulvestrant
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
36
upper Limit
91
value
65
group Id
BG001
lower Limit
27
upper Limit
92
value
65
group Id
BG002
lower Limit
27
upper Limit
92
value
65
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
141
group Id
BG002
value
280
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
206
group Id
BG001
value
208
group Id
BG002
value
414
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
No
param Type
NUMBER
title
Prior adjuvant tamoxifen
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
129
group Id
BG002
value
232
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
242
group Id
BG001
value
220
group Id
BG002
value
462
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
No
param Type
NUMBER
title
Prior adjuvant chemotherapy
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
188
group Id
BG001
value
188
group Id
BG002
value
376
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
157
group Id
BG001
value
161
group Id
BG002
value
318
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
No
param Type
NUMBER
title
Measurable disease
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
75
group Id
BG002
value
151
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Bone only
categories
measurements
group Id
BG000
value
167
group Id
BG001
value
181
group Id
BG002
value
348
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Visceral
categories
measurements
group Id
BG000
value
102
group Id
BG001
value
93
group Id
BG002
value
195
denoms
counts
group Id
BG000
value
345
group Id
BG001
value
349
group Id
BG002
value
694
units
Participants
title
Nonvisceral
param Type
NUMBER
title
Disease site
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
141
group Id
BG001
value
122
group Id
BG002
value
263
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
None
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
47
group Id
BG002
value
87
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
3 mo to < 5 yr
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
66
group Id
BG002
value
134
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
5 to < 10 yr
categories
measurements
group Id
BG000
value
88
group Id
BG001
value
104
group Id
BG002
value
192
denoms
counts
group Id
BG000
value
337
group Id
BG001
value
339
group Id
BG002
value
676
units
Participants
title
>= 10 yr
param Type
NUMBER
population Description
Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
title
Time between diagnosis of primary and metastatic disease
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
31
group Id
BG002
value
56
denoms
counts
group Id
BG000
value
295
group Id
BG001
value
297
group Id
BG002
value
592
units
Participants
title
Positive
categories
measurements
group Id
BG000
value
270
group Id
BG001
value
266
group Id
BG002
value
536
denoms
counts
group Id
BG000
value
295
group Id
BG001
value
297
group Id
BG002
value
592
units
Participants
title
Negative
description
HER2 denotes human epidermal growth factor receptor type 2.
param Type
NUMBER
population Description
Only patients with available HER2 status data will be included in the analysis.
title
HER2 status
unit Of Measure
participants

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

Preserved source evidence · Not medical advice