NCT02181413 · BASELINE

Baseline characteristics

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

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

denoms

counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants

groups

description
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
id
BG000
title
Placebo
description
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
id
BG001
title
Ixazomib Citrate
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
7.92
value
58.2
group Id
BG001
spread
8.17
value
56.8
group Id
BG002
spread
8.10
value
57.4
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
127
group Id
BG001
value
229
group Id
BG002
value
356
title
<60 years
measurements
group Id
BG000
value
134
group Id
BG001
value
166
group Id
BG002
value
300
title
≥60 and <75 years
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
99
group Id
BG001
value
143
group Id
BG002
value
242
title
Female
measurements
group Id
BG000
value
162
group Id
BG001
value
252
group Id
BG002
value
414
title
Male
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
Hispanic or Latino
measurements
group Id
BG000
value
240
group Id
BG001
value
362
group Id
BG002
value
602
title
Not Hispanic or Latino
measurements
group Id
BG000
value
10
group Id
BG001
value
19
group Id
BG002
value
29
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
213
group Id
BG001
value
315
group Id
BG002
value
528
title
White
measurements
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
title
Black or African American
measurements
group Id
BG000
value
36
group Id
BG001
value
59
group Id
BG002
value
95
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Other
measurements
group Id
BG000
value
8
group Id
BG001
value
12
group Id
BG002
value
20
title
Not Reported
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
17
group Id
BG002
value
28
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
13
group Id
BG002
value
22
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
23
group Id
BG002
value
40
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Korea, Republic Of
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
8
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Singapore
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
10
group Id
BG002
value
13
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Taiwan, Province Of China
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Thailand
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
30
group Id
BG002
value
42
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
20
group Id
BG002
value
31
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
18
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
France
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
50
group Id
BG002
value
76
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Germany
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.347
value
168.73
group Id
BG001
spread
10.004
value
169.71
group Id
BG002
spread
10.145
value
169.32
denoms
counts
group Id
BG000
value
256
group Id
BG001
value
388
group Id
BG002
value
644
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed is the number of participants with available height data.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
14.648
value
75.18
group Id
BG001
spread
15.989
value
75.93
group Id
BG002
spread
15.463
value
75.63
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed is the number of participants with available weight data.
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
0.221
value
1.87
group Id
BG001
spread
0.235
value
1.88
group Id
BG002
spread
0.229
value
1.88
denoms
counts
group Id
BG000
value
256
group Id
BG001
value
388
group Id
BG002
value
644
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed is the number of participants with available BSA data.
title
Body Surface Area (BSA)
unit Of Measure
m^2

population Description

Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data.

Complete source fields

denoms

counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants

groups

description
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
id
BG000
title
Placebo
description
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
id
BG001
title
Ixazomib Citrate
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
7.92
value
58.2
group Id
BG001
spread
8.17
value
56.8
group Id
BG002
spread
8.10
value
57.4
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
127
group Id
BG001
value
229
group Id
BG002
value
356
title
<60 years
measurements
group Id
BG000
value
134
group Id
BG001
value
166
group Id
BG002
value
300
title
≥60 and <75 years
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
99
group Id
BG001
value
143
group Id
BG002
value
242
title
Female
measurements
group Id
BG000
value
162
group Id
BG001
value
252
group Id
BG002
value
414
title
Male
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
Hispanic or Latino
measurements
group Id
BG000
value
240
group Id
BG001
value
362
group Id
BG002
value
602
title
Not Hispanic or Latino
measurements
group Id
BG000
value
10
group Id
BG001
value
19
group Id
BG002
value
29
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
213
group Id
BG001
value
315
group Id
BG002
value
528
title
White
measurements
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
title
Black or African American
measurements
group Id
BG000
value
36
group Id
BG001
value
59
group Id
BG002
value
95
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Other
measurements
group Id
BG000
value
8
group Id
BG001
value
12
group Id
BG002
value
20
title
Not Reported
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
17
group Id
BG002
value
28
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
13
group Id
BG002
value
22
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
23
group Id
BG002
value
40
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Korea, Republic Of
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
8
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Singapore
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
10
group Id
BG002
value
13
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Taiwan, Province Of China
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Thailand
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
30
group Id
BG002
value
42
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
20
group Id
BG002
value
31
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
18
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
France
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
50
group Id
BG002
value
76
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
title
Germany
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.347
value
168.73
group Id
BG001
spread
10.004
value
169.71
group Id
BG002
spread
10.145
value
169.32
denoms
counts
group Id
BG000
value
256
group Id
BG001
value
388
group Id
BG002
value
644
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed is the number of participants with available height data.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
14.648
value
75.18
group Id
BG001
spread
15.989
value
75.93
group Id
BG002
spread
15.463
value
75.63
denoms
counts
group Id
BG000
value
261
group Id
BG001
value
395
group Id
BG002
value
656
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed is the number of participants with available weight data.
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
0.221
value
1.87
group Id
BG001
spread
0.235
value
1.88
group Id
BG002
spread
0.229
value
1.88
denoms
counts
group Id
BG000
value
256
group Id
BG001
value
388
group Id
BG002
value
644
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed is the number of participants with available BSA data.
title
Body Surface Area (BSA)
unit Of Measure
m^2

population Description

Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data.

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Preserved source evidence · Not medical advice