NCT00103506 · BASELINE

Baseline characteristics

Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma · Source last updated 2015-10-19

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

denoms

counts
group Id
BG000
value
322
group Id
BG001
value
324
group Id
BG002
value
646
units
Participants

groups

description
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
id
BG000
title
Velcade (Bortezomib) Monotherapy
description
Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
id
BG001
title
Doxil/Caelyx Plus Velcade (Bortezomib)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.56
value
61.5
group Id
BG001
spread
9.61
value
61.4
group Id
BG002
spread
9.58
value
61.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
148
group Id
BG001
value
135
group Id
BG002
value
283
title
Female
measurements
group Id
BG000
value
174
group Id
BG001
value
189
group Id
BG002
value
363
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
9
group Id
BG002
value
15
title
ARGENTINA
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
31
group Id
BG002
value
62
title
AUSTRALIA
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
6
group Id
BG002
value
18
title
AUSTRIA
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
14
group Id
BG002
value
20
title
BELGIUM-LUXEMBURG
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
23
group Id
BG002
value
43
title
CANADA
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
22
group Id
BG002
value
36
title
CZECH REPUBLIC
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
28
group Id
BG002
value
49
title
FRANCE
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
title
GREAT BRITAIN
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
21
group Id
BG002
value
46
title
ISRAEL
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
11
group Id
BG002
value
28
title
ITALY
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
32
group Id
BG002
value
61
title
NETHERLANDS
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
17
group Id
BG002
value
52
title
POLAND
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
322
group Id
BG001
value
324
group Id
BG002
value
646
units
Participants

groups

description
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
id
BG000
title
Velcade (Bortezomib) Monotherapy
description
Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
id
BG001
title
Doxil/Caelyx Plus Velcade (Bortezomib)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.56
value
61.5
group Id
BG001
spread
9.61
value
61.4
group Id
BG002
spread
9.58
value
61.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
148
group Id
BG001
value
135
group Id
BG002
value
283
title
Female
measurements
group Id
BG000
value
174
group Id
BG001
value
189
group Id
BG002
value
363
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
9
group Id
BG002
value
15
title
ARGENTINA
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
31
group Id
BG002
value
62
title
AUSTRALIA
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
6
group Id
BG002
value
18
title
AUSTRIA
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
14
group Id
BG002
value
20
title
BELGIUM-LUXEMBURG
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
23
group Id
BG002
value
43
title
CANADA
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
22
group Id
BG002
value
36
title
CZECH REPUBLIC
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
28
group Id
BG002
value
49
title
FRANCE
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
title
GREAT BRITAIN
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
21
group Id
BG002
value
46
title
ISRAEL
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
11
group Id
BG002
value
28
title
ITALY
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
32
group Id
BG002
value
61
title
NETHERLANDS
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
17
group Id
BG002
value
52
title
POLAND
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

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

Preserved source evidence · Not medical advice