NCT02610777 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2022-09-19

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

denoms

counts
group Id
BG000
value
62
group Id
BG001
value
58
group Id
BG002
value
120
units
Participants

groups

description
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
id
BG000
title
Azacitidine 75 mg/m^2
description
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
id
BG001
title
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.87
value
69.5
group Id
BG001
spread
9.63
value
71.7
group Id
BG002
spread
9.27
value
70.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
16
group Id
BG002
value
37
title
Female
measurements
group Id
BG000
value
41
group Id
BG001
value
42
group Id
BG002
value
83
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Hispanic or Latino
measurements
group Id
BG000
value
55
group Id
BG001
value
52
group Id
BG002
value
107
title
Not Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
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
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Black or African American
measurements
group Id
BG000
value
54
group Id
BG001
value
52
group Id
BG002
value
106
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
2
group Id
BG001
value
3
group Id
BG002
value
5
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
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Canada
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
18
group Id
BG002
value
45
title
United States
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
10
title
Belgium
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
10
group Id
BG002
value
15
title
Bulgaria
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Czech Republic
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Germany
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
14
group Id
BG002
value
22
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
France
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Ireland
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Israel
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
11
title
Italy
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.857
value
169.12
group Id
BG001
spread
7.510
value
168.87
group Id
BG002
spread
9.352
value
169.00
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Height
unit Of Measure
centimeter (cm)
classes
categories
measurements
group Id
BG000
spread
18.471
value
79.19
group Id
BG001
spread
13.716
value
75.95
group Id
BG002
spread
16.359
value
77.62
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kilogram (kg)
classes
categories
measurements
group Id
BG000
spread
0.265
value
1.92
group Id
BG001
spread
0.201
value
1.88
group Id
BG002
spread
0.236
value
1.90
description
Body surface area was defined as \[height (cm) × weight (kg)/3600\]½ based on height and weight collected at baseline.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Body Surface Area
unit Of Measure
square meter (m^2)

population Description

Intent-to-treat (IIT) population was defined as all participants who were randomized.

Complete source fields

denoms

counts
group Id
BG000
value
62
group Id
BG001
value
58
group Id
BG002
value
120
units
Participants

groups

description
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
id
BG000
title
Azacitidine 75 mg/m^2
description
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
id
BG001
title
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.87
value
69.5
group Id
BG001
spread
9.63
value
71.7
group Id
BG002
spread
9.27
value
70.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
16
group Id
BG002
value
37
title
Female
measurements
group Id
BG000
value
41
group Id
BG001
value
42
group Id
BG002
value
83
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Hispanic or Latino
measurements
group Id
BG000
value
55
group Id
BG001
value
52
group Id
BG002
value
107
title
Not Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
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
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Black or African American
measurements
group Id
BG000
value
54
group Id
BG001
value
52
group Id
BG002
value
106
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
2
group Id
BG001
value
3
group Id
BG002
value
5
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
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Canada
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
18
group Id
BG002
value
45
title
United States
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
10
title
Belgium
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
10
group Id
BG002
value
15
title
Bulgaria
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Czech Republic
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Germany
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
14
group Id
BG002
value
22
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
France
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Ireland
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Israel
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
11
title
Italy
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.857
value
169.12
group Id
BG001
spread
7.510
value
168.87
group Id
BG002
spread
9.352
value
169.00
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Height
unit Of Measure
centimeter (cm)
classes
categories
measurements
group Id
BG000
spread
18.471
value
79.19
group Id
BG001
spread
13.716
value
75.95
group Id
BG002
spread
16.359
value
77.62
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kilogram (kg)
classes
categories
measurements
group Id
BG000
spread
0.265
value
1.92
group Id
BG001
spread
0.201
value
1.88
group Id
BG002
spread
0.236
value
1.90
description
Body surface area was defined as \[height (cm) × weight (kg)/3600\]½ based on height and weight collected at baseline.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Body Surface Area
unit Of Measure
square meter (m^2)

population Description

Intent-to-treat (IIT) population was defined as all participants who were randomized.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice