NCT00295646 · BASELINE

Baseline characteristics

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid · Source last updated 2024-03-15

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

denoms

counts
group Id
BG000
value
450
group Id
BG001
value
450
group Id
BG002
value
453
group Id
BG003
value
450
group Id
BG004
value
1803
units
Participants

groups

description
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG000
title
AZ (Arimidex+Zoledronate)
description
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG001
title
TZ (Tamoxifen+Zoledronate)
description
Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG002
title
AC (Arimidex Control)
description
Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG003
title
TC (Tamoxifen Control)
description
Total of all reporting groups
id
BG004
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
28
upper Limit
56
value
44
group Id
BG001
lower Limit
27
upper Limit
54
value
45
group Id
BG002
lower Limit
25
upper Limit
58
value
44
group Id
BG003
lower Limit
27
upper Limit
56
value
45
group Id
BG004
lower Limit
25
upper Limit
58
value
45
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
450
group Id
BG001
value
450
group Id
BG002
value
453
group Id
BG003
value
450
group Id
BG004
value
1803
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
343
group Id
BG001
value
339
group Id
BG002
value
352
group Id
BG003
value
341
group Id
BG004
value
1375
title
pT1
measurements
group Id
BG000
value
98
group Id
BG001
value
97
group Id
BG002
value
93
group Id
BG003
value
98
group Id
BG004
value
386
title
pT2/pT3
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
description
The pathologic T-stage (pT) describes the categories of tumor size: pT1: \<2 cm, pT2: 2 to 5 cm, pT3: \> 5 cm.
param Type
COUNT_OF_PARTICIPANTS
title
pT-stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
304
group Id
BG001
value
298
group Id
BG002
value
304
group Id
BG003
value
305
group Id
BG004
value
1211
title
Negative
measurements
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
141
group Id
BG003
value
134
group Id
BG004
value
550
title
Positive
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
description
The pathologic N-stage (pN) describes the categories of affected lymph nodes: negative: no lymph node affected, positive: at least one lymph node affected.
param Type
COUNT_OF_PARTICIPANTS
title
pN-stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
341
group Id
BG001
value
347
group Id
BG002
value
347
group Id
BG003
value
346
group Id
BG004
value
1381
title
G1/G2
measurements
group Id
BG000
value
93
group Id
BG001
value
85
group Id
BG002
value
89
group Id
BG003
value
85
group Id
BG004
value
352
title
G3
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
9
group Id
BG003
value
8
group Id
BG004
value
28
title
GX
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
description
The histologic grade describes to which extent the cancer cells and their arrangement look look like normal cells. Grade 1 (G1): well-differentiated, cells look more like normal breast tissue; Grade (G2): moderately differentiated; Grade (G3): poorly differentiated; GX: grade cannot be assessed.
param Type
COUNT_OF_PARTICIPANTS
title
Histologic grade
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
20
group Id
BG002
value
14
group Id
BG003
value
16
group Id
BG004
value
67
title
Negative
measurements
group Id
BG000
value
424
group Id
BG001
value
416
group Id
BG002
value
431
group Id
BG003
value
423
group Id
BG004
value
1694
title
Positive
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Estrogen receptor status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
32
group Id
BG002
value
35
group Id
BG003
value
40
group Id
BG004
value
143
title
Negative
measurements
group Id
BG000
value
405
group Id
BG001
value
404
group Id
BG002
value
409
group Id
BG003
value
399
group Id
BG004
value
1617
title
Positive
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
9
group Id
BG003
value
11
group Id
BG004
value
43
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Progesterone receptor status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
386
group Id
BG001
value
382
group Id
BG002
value
389
group Id
BG003
value
379
group Id
BG004
value
1536
title
No
measurements
group Id
BG000
value
26
group Id
BG001
value
23
group Id
BG002
value
23
group Id
BG003
value
25
group Id
BG004
value
97
title
Yes
measurements
group Id
BG000
value
38
group Id
BG001
value
45
group Id
BG002
value
41
group Id
BG003
value
46
group Id
BG004
value
170
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Preoperative chemotherapy
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
450
group Id
BG001
value
450
group Id
BG002
value
453
group Id
BG003
value
450
group Id
BG004
value
1803
units
Participants

groups

description
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG000
title
AZ (Arimidex+Zoledronate)
description
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG001
title
TZ (Tamoxifen+Zoledronate)
description
Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG002
title
AC (Arimidex Control)
description
Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
id
BG003
title
TC (Tamoxifen Control)
description
Total of all reporting groups
id
BG004
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
28
upper Limit
56
value
44
group Id
BG001
lower Limit
27
upper Limit
54
value
45
group Id
BG002
lower Limit
25
upper Limit
58
value
44
group Id
BG003
lower Limit
27
upper Limit
56
value
45
group Id
BG004
lower Limit
25
upper Limit
58
value
45
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
450
group Id
BG001
value
450
group Id
BG002
value
453
group Id
BG003
value
450
group Id
BG004
value
1803
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
343
group Id
BG001
value
339
group Id
BG002
value
352
group Id
BG003
value
341
group Id
BG004
value
1375
title
pT1
measurements
group Id
BG000
value
98
group Id
BG001
value
97
group Id
BG002
value
93
group Id
BG003
value
98
group Id
BG004
value
386
title
pT2/pT3
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
description
The pathologic T-stage (pT) describes the categories of tumor size: pT1: \<2 cm, pT2: 2 to 5 cm, pT3: \> 5 cm.
param Type
COUNT_OF_PARTICIPANTS
title
pT-stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
304
group Id
BG001
value
298
group Id
BG002
value
304
group Id
BG003
value
305
group Id
BG004
value
1211
title
Negative
measurements
group Id
BG000
value
137
group Id
BG001
value
138
group Id
BG002
value
141
group Id
BG003
value
134
group Id
BG004
value
550
title
Positive
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
description
The pathologic N-stage (pN) describes the categories of affected lymph nodes: negative: no lymph node affected, positive: at least one lymph node affected.
param Type
COUNT_OF_PARTICIPANTS
title
pN-stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
341
group Id
BG001
value
347
group Id
BG002
value
347
group Id
BG003
value
346
group Id
BG004
value
1381
title
G1/G2
measurements
group Id
BG000
value
93
group Id
BG001
value
85
group Id
BG002
value
89
group Id
BG003
value
85
group Id
BG004
value
352
title
G3
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
9
group Id
BG003
value
8
group Id
BG004
value
28
title
GX
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
description
The histologic grade describes to which extent the cancer cells and their arrangement look look like normal cells. Grade 1 (G1): well-differentiated, cells look more like normal breast tissue; Grade (G2): moderately differentiated; Grade (G3): poorly differentiated; GX: grade cannot be assessed.
param Type
COUNT_OF_PARTICIPANTS
title
Histologic grade
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
20
group Id
BG002
value
14
group Id
BG003
value
16
group Id
BG004
value
67
title
Negative
measurements
group Id
BG000
value
424
group Id
BG001
value
416
group Id
BG002
value
431
group Id
BG003
value
423
group Id
BG004
value
1694
title
Positive
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
8
group Id
BG003
value
11
group Id
BG004
value
42
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Estrogen receptor status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
32
group Id
BG002
value
35
group Id
BG003
value
40
group Id
BG004
value
143
title
Negative
measurements
group Id
BG000
value
405
group Id
BG001
value
404
group Id
BG002
value
409
group Id
BG003
value
399
group Id
BG004
value
1617
title
Positive
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
9
group Id
BG003
value
11
group Id
BG004
value
43
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Progesterone receptor status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
386
group Id
BG001
value
382
group Id
BG002
value
389
group Id
BG003
value
379
group Id
BG004
value
1536
title
No
measurements
group Id
BG000
value
26
group Id
BG001
value
23
group Id
BG002
value
23
group Id
BG003
value
25
group Id
BG004
value
97
title
Yes
measurements
group Id
BG000
value
38
group Id
BG001
value
45
group Id
BG002
value
41
group Id
BG003
value
46
group Id
BG004
value
170
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Preoperative chemotherapy
unit Of Measure
Participants

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Preserved source evidence · Not medical advice