NCT02668653 · BASELINE

Baseline characteristics

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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

denoms

counts
group Id
BG000
value
268
group Id
BG001
value
271
group Id
BG002
value
539
units
Participants

groups

description
Participants who were randomized to receive the quizartinib treatment regimen.
id
BG000
title
Quizartinib
description
Participants who were randomized to receive placebo treatment regimen.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.07
value
53.6
group Id
BG001
spread
12.81
value
54.3
group Id
BG002
spread
12.93
value
54.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
161
group Id
BG001
value
162
group Id
BG002
value
323
title
<60 years
categories
measurements
group Id
BG000
value
107
group Id
BG001
value
109
group Id
BG002
value
216
title
≥60 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
144
group Id
BG001
value
150
group Id
BG002
value
294
title
Female
measurements
group Id
BG000
value
124
group Id
BG001
value
121
group Id
BG002
value
245
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
American Indian or Alaska Native
categories
measurements
group Id
BG000
value
80
group Id
BG001
value
78
group Id
BG002
value
158
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Black or African American
categories
measurements
group Id
BG000
value
159
group Id
BG001
value
163
group Id
BG002
value
322
title
White
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
24
group Id
BG002
value
51
title
Other
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Singapore
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
21
title
United States
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
15
group Id
BG002
value
32
title
Czechia
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Portugal
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
6
group Id
BG002
value
19
title
Russia
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
34
group Id
BG002
value
70
title
South Korea
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
11
group Id
BG002
value
20
title
China
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
15
title
Brazil
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
8
group Id
BG002
value
11
title
Poland
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Bulgaria
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
12
group Id
BG002
value
25
title
France
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
6
group Id
BG002
value
18
title
Serbia
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

population Description

Demographic and baseline characteristics were assessed in the Intent-to-Treat Analysis Set.

Complete source fields

denoms

counts
group Id
BG000
value
268
group Id
BG001
value
271
group Id
BG002
value
539
units
Participants

groups

description
Participants who were randomized to receive the quizartinib treatment regimen.
id
BG000
title
Quizartinib
description
Participants who were randomized to receive placebo treatment regimen.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.07
value
53.6
group Id
BG001
spread
12.81
value
54.3
group Id
BG002
spread
12.93
value
54.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
161
group Id
BG001
value
162
group Id
BG002
value
323
title
<60 years
categories
measurements
group Id
BG000
value
107
group Id
BG001
value
109
group Id
BG002
value
216
title
≥60 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
144
group Id
BG001
value
150
group Id
BG002
value
294
title
Female
measurements
group Id
BG000
value
124
group Id
BG001
value
121
group Id
BG002
value
245
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
American Indian or Alaska Native
categories
measurements
group Id
BG000
value
80
group Id
BG001
value
78
group Id
BG002
value
158
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Black or African American
categories
measurements
group Id
BG000
value
159
group Id
BG001
value
163
group Id
BG002
value
322
title
White
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
24
group Id
BG002
value
51
title
Other
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Singapore
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
21
title
United States
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
15
group Id
BG002
value
32
title
Czechia
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Portugal
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
6
group Id
BG002
value
19
title
Russia
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
34
group Id
BG002
value
70
title
South Korea
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
11
group Id
BG002
value
20
title
China
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
15
title
Brazil
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
8
group Id
BG002
value
11
title
Poland
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Bulgaria
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
12
group Id
BG002
value
25
title
France
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
6
group Id
BG002
value
18
title
Serbia
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

population Description

Demographic and baseline characteristics were assessed in the Intent-to-Treat Analysis Set.

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

Preserved source evidence · Not medical advice