NCT02855944 · BASELINE

Baseline characteristics

ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients · Source last updated 2023-06-09

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

denoms

counts
group Id
BG000
value
233
group Id
BG001
value
116
group Id
BG002
value
349
units
Participants

groups

description
Patients randomized to the rucaparib arm.
id
BG000
title
Rucaparib
description
Patients randomized to the chemotherapy arm.
id
BG001
title
Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
38
upper Limit
81
value
58.0
group Id
BG001
lower Limit
38
upper Limit
85
value
58.5
group Id
BG002
lower Limit
38
upper Limit
85
value
58.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
233
group Id
BG001
value
116
group Id
BG002
value
349
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
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
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Black or African American
measurements
group Id
BG000
value
219
group Id
BG001
value
113
group Id
BG002
value
332
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
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
125
group Id
BG001
value
72
group Id
BG002
value
197
title
ECOG 0
measurements
group Id
BG000
value
108
group Id
BG001
value
44
group Id
BG002
value
152
title
ECOG 1
description
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work or office work).
param Type
COUNT_OF_PARTICIPANTS
title
ECOG at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
134
group Id
BG001
value
68
group Id
BG002
value
202
title
2
measurements
group Id
BG000
value
58
group Id
BG001
value
28
group Id
BG002
value
86
title
3
measurements
group Id
BG000
value
23
group Id
BG001
value
11
group Id
BG002
value
34
title
4
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
title
5
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
>5
param Type
COUNT_OF_PARTICIPANTS
title
Number of Prior Chemotherapy Regimens
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
6
group Id
BG002
value
18
title
1
measurements
group Id
BG000
value
156
group Id
BG001
value
74
group Id
BG002
value
230
title
2
measurements
group Id
BG000
value
48
group Id
BG001
value
28
group Id
BG002
value
76
title
3
measurements
group Id
BG000
value
11
group Id
BG001
value
7
group Id
BG002
value
18
title
4
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
5
measurements
group Id
BG000
value
4
group Id
BG001
value
0
group Id
BG002
value
4
title
>5
param Type
COUNT_OF_PARTICIPANTS
title
Number of Prior Platinum Regimens
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
120
group Id
BG001
value
59
group Id
BG002
value
179
title
Platinum resistant
measurements
group Id
BG000
value
65
group Id
BG001
value
31
group Id
BG002
value
96
title
Partially platinum-sensitive
measurements
group Id
BG000
value
48
group Id
BG001
value
26
group Id
BG002
value
74
title
Platinum sensitive
description
* Platinum resistant: patients who progressed ≥ 1 to \< 6 months after the last dose of platinum-based chemotherapy; * Partially platinum-sensitive: patients who progressed ≥ 6 to \< 12 months after last dose of platinum-based chemotherapy; and * Platinum sensitive: patients who progressed ≥ 12 months after last dose of platinum-based chemotherapy
param Type
COUNT_OF_PARTICIPANTS
title
Randomization Stratification: Platinum Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
181
group Id
BG001
value
79
group Id
BG002
value
260
title
BRCA1
measurements
group Id
BG000
value
52
group Id
BG001
value
36
group Id
BG002
value
88
title
BRCA2
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Non-BRCA
description
* BRCA1: patients with a deleterious breast cancer susceptibility gene 1 (BRCA1) mutation in their tumor * BRCA2: patients with a deleterious breast cancer susceptibility gene 2 (BRCA2) mutation in their tumor * Non-BRCA: patients without a BRCA mutation in their tumor
param Type
COUNT_OF_PARTICIPANTS
title
Combined Local and Central Lab BRCA Mutation Results
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
198
group Id
BG001
value
95
group Id
BG002
value
293
title
Germline
measurements
group Id
BG000
value
35
group Id
BG001
value
19
group Id
BG002
value
54
title
Somatic
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Not Available
param Type
COUNT_OF_PARTICIPANTS
title
Mutation Type
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
10
group Id
BG002
value
23
param Type
COUNT_OF_PARTICIPANTS
title
Patients with a BRCA Reversion Mutation
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
233
group Id
BG001
value
116
group Id
BG002
value
349
units
Participants

groups

description
Patients randomized to the rucaparib arm.
id
BG000
title
Rucaparib
description
Patients randomized to the chemotherapy arm.
id
BG001
title
Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
38
upper Limit
81
value
58.0
group Id
BG001
lower Limit
38
upper Limit
85
value
58.5
group Id
BG002
lower Limit
38
upper Limit
85
value
58.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
233
group Id
BG001
value
116
group Id
BG002
value
349
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
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
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Black or African American
measurements
group Id
BG000
value
219
group Id
BG001
value
113
group Id
BG002
value
332
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
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
125
group Id
BG001
value
72
group Id
BG002
value
197
title
ECOG 0
measurements
group Id
BG000
value
108
group Id
BG001
value
44
group Id
BG002
value
152
title
ECOG 1
description
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work or office work).
param Type
COUNT_OF_PARTICIPANTS
title
ECOG at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
134
group Id
BG001
value
68
group Id
BG002
value
202
title
2
measurements
group Id
BG000
value
58
group Id
BG001
value
28
group Id
BG002
value
86
title
3
measurements
group Id
BG000
value
23
group Id
BG001
value
11
group Id
BG002
value
34
title
4
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
title
5
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
>5
param Type
COUNT_OF_PARTICIPANTS
title
Number of Prior Chemotherapy Regimens
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
6
group Id
BG002
value
18
title
1
measurements
group Id
BG000
value
156
group Id
BG001
value
74
group Id
BG002
value
230
title
2
measurements
group Id
BG000
value
48
group Id
BG001
value
28
group Id
BG002
value
76
title
3
measurements
group Id
BG000
value
11
group Id
BG001
value
7
group Id
BG002
value
18
title
4
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
5
measurements
group Id
BG000
value
4
group Id
BG001
value
0
group Id
BG002
value
4
title
>5
param Type
COUNT_OF_PARTICIPANTS
title
Number of Prior Platinum Regimens
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
120
group Id
BG001
value
59
group Id
BG002
value
179
title
Platinum resistant
measurements
group Id
BG000
value
65
group Id
BG001
value
31
group Id
BG002
value
96
title
Partially platinum-sensitive
measurements
group Id
BG000
value
48
group Id
BG001
value
26
group Id
BG002
value
74
title
Platinum sensitive
description
* Platinum resistant: patients who progressed ≥ 1 to \< 6 months after the last dose of platinum-based chemotherapy; * Partially platinum-sensitive: patients who progressed ≥ 6 to \< 12 months after last dose of platinum-based chemotherapy; and * Platinum sensitive: patients who progressed ≥ 12 months after last dose of platinum-based chemotherapy
param Type
COUNT_OF_PARTICIPANTS
title
Randomization Stratification: Platinum Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
181
group Id
BG001
value
79
group Id
BG002
value
260
title
BRCA1
measurements
group Id
BG000
value
52
group Id
BG001
value
36
group Id
BG002
value
88
title
BRCA2
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Non-BRCA
description
* BRCA1: patients with a deleterious breast cancer susceptibility gene 1 (BRCA1) mutation in their tumor * BRCA2: patients with a deleterious breast cancer susceptibility gene 2 (BRCA2) mutation in their tumor * Non-BRCA: patients without a BRCA mutation in their tumor
param Type
COUNT_OF_PARTICIPANTS
title
Combined Local and Central Lab BRCA Mutation Results
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
198
group Id
BG001
value
95
group Id
BG002
value
293
title
Germline
measurements
group Id
BG000
value
35
group Id
BG001
value
19
group Id
BG002
value
54
title
Somatic
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Not Available
param Type
COUNT_OF_PARTICIPANTS
title
Mutation Type
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
10
group Id
BG002
value
23
param Type
COUNT_OF_PARTICIPANTS
title
Patients with a BRCA Reversion Mutation
unit Of Measure
Participants

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Preserved source evidence · Not medical advice