NCT03268954 · BASELINE

Baseline characteristics

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2025-10-29

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

denoms

counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants

groups

description
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
id
BG000
title
Azacitidine 75 mg/m^2
description
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
id
BG001
title
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.22
value
73.0
group Id
BG001
spread
7.65
value
73.0
group Id
BG002
spread
7.93
value
73
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
85
group Id
BG001
value
95
group Id
BG002
value
180
title
Female
measurements
group Id
BG000
value
142
group Id
BG001
value
132
group Id
BG002
value
274
title
Male
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
31
group Id
BG002
value
57
title
Hispanic or Latino
measurements
group Id
BG000
value
188
group Id
BG001
value
189
group Id
BG002
value
377
title
Not Hispanic or Latino
measurements
group Id
BG000
value
13
group Id
BG001
value
7
group Id
BG002
value
20
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
American Indian or Alaska Native
measurements
group Id
BG000
value
20
group Id
BG001
value
31
group Id
BG002
value
51
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
2
group Id
BG002
value
3
title
Black or African American
measurements
group Id
BG000
value
189
group Id
BG001
value
180
group Id
BG002
value
369
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
15
group Id
BG001
value
10
group Id
BG002
value
25
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
3
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
18
group Id
BG002
value
28
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Brazil
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
China
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
6
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
3
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
23
group Id
BG002
value
49
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
8
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
France
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
United Kingdom
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
28
group Id
BG002
value
58
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Israel
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
9
group Id
BG002
value
23
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Italy
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
9.439
value
167.59
group Id
BG001
spread
10.098
value
166.31
group Id
BG002
spread
9.783
value
166.95
denoms
counts
group Id
BG000
value
225
group Id
BG001
value
223
group Id
BG002
value
448
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
ITT Population included all participants who were randomized. Number analyzed is the number of participants with data available for height at Baseline.
title
Height
unit Of Measure
centimeter (cm)
classes
categories
measurements
group Id
BG000
spread
16.143
value
77.65
group Id
BG001
spread
15.996
value
75.82
group Id
BG002
spread
16.078
value
76.73
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
226
group Id
BG002
value
453
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
ITT Population included all participants who were randomized. Number analyzed is the number of participants with data available for weight at Baseline.
title
Weight
unit Of Measure
kilogram (kg)
classes
categories
measurements
group Id
BG000
spread
0.228
value
1.89
group Id
BG001
spread
0.233
value
1.86
group Id
BG002
spread
0.231
value
1.88
denoms
counts
group Id
BG000
value
225
group Id
BG001
value
223
group Id
BG002
value
448
units
Participants
description
Body surface area is defined as \[height (cm) × weight (kg) / 3600\]\^1/2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
ITT Population included all participants who were randomized. Number analyzed is the number of participants with data available for body surface area at Baseline.
title
Body Surface Area
unit Of Measure
meter square (m^2)

population Description

ITT Population included all participants who were randomized.

Complete source fields

denoms

counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants

groups

description
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
id
BG000
title
Azacitidine 75 mg/m^2
description
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
id
BG001
title
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.22
value
73.0
group Id
BG001
spread
7.65
value
73.0
group Id
BG002
spread
7.93
value
73
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
85
group Id
BG001
value
95
group Id
BG002
value
180
title
Female
measurements
group Id
BG000
value
142
group Id
BG001
value
132
group Id
BG002
value
274
title
Male
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
31
group Id
BG002
value
57
title
Hispanic or Latino
measurements
group Id
BG000
value
188
group Id
BG001
value
189
group Id
BG002
value
377
title
Not Hispanic or Latino
measurements
group Id
BG000
value
13
group Id
BG001
value
7
group Id
BG002
value
20
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
American Indian or Alaska Native
measurements
group Id
BG000
value
20
group Id
BG001
value
31
group Id
BG002
value
51
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
2
group Id
BG002
value
3
title
Black or African American
measurements
group Id
BG000
value
189
group Id
BG001
value
180
group Id
BG002
value
369
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
15
group Id
BG001
value
10
group Id
BG002
value
25
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
3
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
18
group Id
BG002
value
28
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Brazil
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
China
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
6
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
3
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
23
group Id
BG002
value
49
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
8
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
France
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
United Kingdom
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
28
group Id
BG002
value
58
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Israel
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
9
group Id
BG002
value
23
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
227
group Id
BG002
value
454
units
Participants
title
Italy
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
9.439
value
167.59
group Id
BG001
spread
10.098
value
166.31
group Id
BG002
spread
9.783
value
166.95
denoms
counts
group Id
BG000
value
225
group Id
BG001
value
223
group Id
BG002
value
448
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
ITT Population included all participants who were randomized. Number analyzed is the number of participants with data available for height at Baseline.
title
Height
unit Of Measure
centimeter (cm)
classes
categories
measurements
group Id
BG000
spread
16.143
value
77.65
group Id
BG001
spread
15.996
value
75.82
group Id
BG002
spread
16.078
value
76.73
denoms
counts
group Id
BG000
value
227
group Id
BG001
value
226
group Id
BG002
value
453
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
ITT Population included all participants who were randomized. Number analyzed is the number of participants with data available for weight at Baseline.
title
Weight
unit Of Measure
kilogram (kg)
classes
categories
measurements
group Id
BG000
spread
0.228
value
1.89
group Id
BG001
spread
0.233
value
1.86
group Id
BG002
spread
0.231
value
1.88
denoms
counts
group Id
BG000
value
225
group Id
BG001
value
223
group Id
BG002
value
448
units
Participants
description
Body surface area is defined as \[height (cm) × weight (kg) / 3600\]\^1/2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
ITT Population included all participants who were randomized. Number analyzed is the number of participants with data available for body surface area at Baseline.
title
Body Surface Area
unit Of Measure
meter square (m^2)

population Description

ITT Population included all participants who were randomized.

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Preserved source evidence · Not medical advice