NCT02000622 · BASELINE

Baseline characteristics

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. · Source last updated 2026-02-13

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

denoms

counts
group Id
BG000
value
205
group Id
BG001
value
97
group Id
BG002
value
302
units
Participants

groups

id
BG000
title
Olaparib 300 mg bd
id
BG001
title
Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
22
upper Limit
76
value
44
group Id
BG001
lower Limit
24
upper Limit
68
value
45
group Id
BG002
lower Limit
22
upper Limit
76
value
44
title
Age (years)
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
138
group Id
BG001
value
63
group Id
BG002
value
201
title
<50
measurements
group Id
BG000
value
56
group Id
BG001
value
30
group Id
BG002
value
86
title
>=50-<65
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
>=65
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
200
group Id
BG001
value
95
group Id
BG002
value
295
title
Female
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
66
group Id
BG001
value
28
group Id
BG002
value
94
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
1
group Id
BG001
value
4
group Id
BG002
value
5
title
Black or African American
measurements
group Id
BG000
value
134
group Id
BG001
value
63
group Id
BG002
value
197
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
1
group Id
BG001
value
1
group Id
BG002
value
2
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
4
group Id
BG001
value
4
group Id
BG002
value
8
title
BULGARIA
measurements
group Id
BG000
value
32
group Id
BG001
value
9
group Id
BG002
value
41
title
CHINA
measurements
group Id
BG000
value
11
group Id
BG001
value
1
group Id
BG002
value
12
title
CZECH REPUBLIC
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
FRANCE
measurements
group Id
BG000
value
10
group Id
BG001
value
0
group Id
BG002
value
10
title
HUNGARY
measurements
group Id
BG000
value
17
group Id
BG001
value
7
group Id
BG002
value
24
title
ITALY
measurements
group Id
BG000
value
15
group Id
BG001
value
9
group Id
BG002
value
24
title
JAPAN
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
20
title
KOREA
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
5
title
MEXICO
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
PERU
measurements
group Id
BG000
value
10
group Id
BG001
value
5
group Id
BG002
value
15
title
POLAND
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
ROMANIA
title
Global
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
49
group Id
BG002
value
152
title
ER and/or PgR positive
measurements
group Id
BG000
value
102
group Id
BG001
value
48
group Id
BG002
value
150
title
ER and PgR negative
description
ER = oestrogen receptor, PgR = progesterone receptor. All patients were HER2 negative.
param Type
COUNT_OF_PARTICIPANTS
title
Receptor status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
69
group Id
BG002
value
215
title
Yes
measurements
group Id
BG000
value
59
group Id
BG001
value
28
group Id
BG002
value
87
title
No
param Type
COUNT_OF_PARTICIPANTS
title
Received prior chemotherapy for metastatic breast cancer
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
60
group Id
BG001
value
26
group Id
BG002
value
86
title
Yes
measurements
group Id
BG000
value
145
group Id
BG001
value
71
group Id
BG002
value
216
title
No
param Type
COUNT_OF_PARTICIPANTS
title
Received prior platinum for breast cancer
unit Of Measure
Participants

population Description

Full analysis set consisting of all randomized patients.

Complete source fields

denoms

counts
group Id
BG000
value
205
group Id
BG001
value
97
group Id
BG002
value
302
units
Participants

groups

id
BG000
title
Olaparib 300 mg bd
id
BG001
title
Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
22
upper Limit
76
value
44
group Id
BG001
lower Limit
24
upper Limit
68
value
45
group Id
BG002
lower Limit
22
upper Limit
76
value
44
title
Age (years)
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
138
group Id
BG001
value
63
group Id
BG002
value
201
title
<50
measurements
group Id
BG000
value
56
group Id
BG001
value
30
group Id
BG002
value
86
title
>=50-<65
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
>=65
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
200
group Id
BG001
value
95
group Id
BG002
value
295
title
Female
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
66
group Id
BG001
value
28
group Id
BG002
value
94
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
1
group Id
BG001
value
4
group Id
BG002
value
5
title
Black or African American
measurements
group Id
BG000
value
134
group Id
BG001
value
63
group Id
BG002
value
197
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
1
group Id
BG001
value
1
group Id
BG002
value
2
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
4
group Id
BG001
value
4
group Id
BG002
value
8
title
BULGARIA
measurements
group Id
BG000
value
32
group Id
BG001
value
9
group Id
BG002
value
41
title
CHINA
measurements
group Id
BG000
value
11
group Id
BG001
value
1
group Id
BG002
value
12
title
CZECH REPUBLIC
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
FRANCE
measurements
group Id
BG000
value
10
group Id
BG001
value
0
group Id
BG002
value
10
title
HUNGARY
measurements
group Id
BG000
value
17
group Id
BG001
value
7
group Id
BG002
value
24
title
ITALY
measurements
group Id
BG000
value
15
group Id
BG001
value
9
group Id
BG002
value
24
title
JAPAN
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
20
title
KOREA
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
5
title
MEXICO
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
PERU
measurements
group Id
BG000
value
10
group Id
BG001
value
5
group Id
BG002
value
15
title
POLAND
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
ROMANIA
title
Global
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
49
group Id
BG002
value
152
title
ER and/or PgR positive
measurements
group Id
BG000
value
102
group Id
BG001
value
48
group Id
BG002
value
150
title
ER and PgR negative
description
ER = oestrogen receptor, PgR = progesterone receptor. All patients were HER2 negative.
param Type
COUNT_OF_PARTICIPANTS
title
Receptor status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
69
group Id
BG002
value
215
title
Yes
measurements
group Id
BG000
value
59
group Id
BG001
value
28
group Id
BG002
value
87
title
No
param Type
COUNT_OF_PARTICIPANTS
title
Received prior chemotherapy for metastatic breast cancer
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
60
group Id
BG001
value
26
group Id
BG002
value
86
title
Yes
measurements
group Id
BG000
value
145
group Id
BG001
value
71
group Id
BG002
value
216
title
No
param Type
COUNT_OF_PARTICIPANTS
title
Received prior platinum for breast cancer
unit Of Measure
Participants

population Description

Full analysis set consisting of all randomized patients.

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

Preserved source evidence · Not medical advice