NCT00417079 · BASELINE

Baseline characteristics

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer · Source last updated 2011-03-10

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

denoms

counts
group Id
BG000
value
377
group Id
BG001
value
378
group Id
BG002
value
755
units
Participants

groups

description
mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
id
BG000
title
Mitoxantrone + Prednisone
description
cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
id
BG001
title
Cabazitaxel + Prednisone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
47
upper Limit
89
value
67.0
group Id
BG001
lower Limit
46
upper Limit
92
value
68.0
group Id
BG002
lower Limit
46
upper Limit
92
value
67
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
377
group Id
BG001
value
378
group Id
BG002
value
755
title
Male
param Type
NUMBER
title
Sex/Gender, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
106
group Id
BG001
value
97
group Id
BG002
value
203
title
United States
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
11
title
Taiwan
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Slovakia
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
19
title
Spain
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
12
group Id
BG002
value
21
title
Chile
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
title
Russian Federation
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
35
title
Italy
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
20
title
India
categories
measurements
group Id
BG000
value
44
group Id
BG001
value
46
group Id
BG002
value
90
title
France
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
26
group Id
BG002
value
45
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
9
group Id
BG002
value
16
title
South Africa
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
17
title
Netherlands
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
120
group Id
BG001
value
141
group Id
BG002
value
261
title
0 - Fully Active
categories
measurements
group Id
BG000
value
224
group Id
BG001
value
209
group Id
BG002
value
433
title
1 - Ambulatory, Restricted Activity
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
28
group Id
BG002
value
61
title
2 - Ambulatory, No Work Activities
param Type
NUMBER
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
2
upper Limit
11220
value
127.5
group Id
BG001
lower Limit
2
upper Limit
7842
value
143.9
group Id
BG002
lower Limit
2
upper Limit
11220
value
135.00
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Prostatic Specific Antigen PSA
unit Of Measure
ng/mL
classes
categories
measurements
group Id
BG000
value
204
group Id
BG001
value
201
group Id
BG002
value
405
title
Measurable disease
categories
measurements
group Id
BG000
value
173
group Id
BG001
value
177
group Id
BG002
value
350
title
Not Measurable disease
description
Measurability of the disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Patients with measurable disease have at least one visceral or soft tissue metastatic lesion (including new lesion). Patient with non-measurable disease have documented rising PSA levels or appearance of new lesion.
param Type
NUMBER
title
Measurable disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
356
group Id
BG001
value
364
group Id
BG002
value
720
title
Metastatic
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
14
group Id
BG002
value
34
title
Locoregional Recurrence
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
description
Extent of the disease at screening stage: * Metastatic: bone or visceral metastases. * Locoregional recurrence includes local recurrent tumor at the primary site, along the draining lymphatic channels, or within the draining lymphatic nodal basin.
param Type
NUMBER
title
Extent of disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
134
group Id
BG001
value
146
group Id
BG002
value
280
title
1
categories
measurements
group Id
BG000
value
117
group Id
BG001
value
112
group Id
BG002
value
229
title
2
categories
measurements
group Id
BG000
value
78
group Id
BG001
value
73
group Id
BG002
value
151
title
3
categories
measurements
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
title
4 or more
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Missing
param Type
NUMBER
title
Tumor Location: number of sites involved
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
377
group Id
BG001
value
378
group Id
BG002
value
755
units
Participants

groups

description
mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
id
BG000
title
Mitoxantrone + Prednisone
description
cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
id
BG001
title
Cabazitaxel + Prednisone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
47
upper Limit
89
value
67.0
group Id
BG001
lower Limit
46
upper Limit
92
value
68.0
group Id
BG002
lower Limit
46
upper Limit
92
value
67
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
377
group Id
BG001
value
378
group Id
BG002
value
755
title
Male
param Type
NUMBER
title
Sex/Gender, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
106
group Id
BG001
value
97
group Id
BG002
value
203
title
United States
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
11
title
Taiwan
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Slovakia
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
19
title
Spain
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
12
group Id
BG002
value
21
title
Chile
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
title
Russian Federation
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
35
title
Italy
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
20
title
India
categories
measurements
group Id
BG000
value
44
group Id
BG001
value
46
group Id
BG002
value
90
title
France
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
26
group Id
BG002
value
45
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
9
group Id
BG002
value
16
title
South Africa
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
17
title
Netherlands
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
120
group Id
BG001
value
141
group Id
BG002
value
261
title
0 - Fully Active
categories
measurements
group Id
BG000
value
224
group Id
BG001
value
209
group Id
BG002
value
433
title
1 - Ambulatory, Restricted Activity
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
28
group Id
BG002
value
61
title
2 - Ambulatory, No Work Activities
param Type
NUMBER
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
2
upper Limit
11220
value
127.5
group Id
BG001
lower Limit
2
upper Limit
7842
value
143.9
group Id
BG002
lower Limit
2
upper Limit
11220
value
135.00
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Prostatic Specific Antigen PSA
unit Of Measure
ng/mL
classes
categories
measurements
group Id
BG000
value
204
group Id
BG001
value
201
group Id
BG002
value
405
title
Measurable disease
categories
measurements
group Id
BG000
value
173
group Id
BG001
value
177
group Id
BG002
value
350
title
Not Measurable disease
description
Measurability of the disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Patients with measurable disease have at least one visceral or soft tissue metastatic lesion (including new lesion). Patient with non-measurable disease have documented rising PSA levels or appearance of new lesion.
param Type
NUMBER
title
Measurable disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
356
group Id
BG001
value
364
group Id
BG002
value
720
title
Metastatic
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
14
group Id
BG002
value
34
title
Locoregional Recurrence
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
description
Extent of the disease at screening stage: * Metastatic: bone or visceral metastases. * Locoregional recurrence includes local recurrent tumor at the primary site, along the draining lymphatic channels, or within the draining lymphatic nodal basin.
param Type
NUMBER
title
Extent of disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
134
group Id
BG001
value
146
group Id
BG002
value
280
title
1
categories
measurements
group Id
BG000
value
117
group Id
BG001
value
112
group Id
BG002
value
229
title
2
categories
measurements
group Id
BG000
value
78
group Id
BG001
value
73
group Id
BG002
value
151
title
3
categories
measurements
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
title
4 or more
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Missing
param Type
NUMBER
title
Tumor Location: number of sites involved
unit Of Measure
Participants

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Preserved source evidence · Not medical advice