NCT00306202 · BASELINE

Baseline characteristics

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26

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

denoms

counts
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
24
group Id
BG003
value
58
units
Participants

groups

description
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
id
BG000
title
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
description
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
id
BG001
title
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
id
BG002
title
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
4.1
value
12.4
group Id
BG001
spread
4.3
value
9.7
group Id
BG002
spread
5.6
value
8.6
group Id
BG003
spread
5.0
value
10.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
2
group Id
BG003
value
2
title
< 2 years
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
14
title
Between 2 and 6 years
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
18
title
Between 7 and 11 years
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
7
group Id
BG002
value
7
group Id
BG003
value
23
title
Between 12 and 18 years
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
> 18 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
8
group Id
BG003
value
19
title
Female
measurements
group Id
BG000
value
11
group Id
BG001
value
12
group Id
BG002
value
16
group Id
BG003
value
39
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
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Not Hispanic or Latino
measurements
group Id
BG000
value
17
group Id
BG001
value
16
group Id
BG002
value
24
group Id
BG003
value
57
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
16
group Id
BG001
value
15
group Id
BG002
value
21
group Id
BG003
value
52
title
White
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Black/African American
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Other
description
Race only
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
24
group Id
BG003
value
58
units
Participants

groups

description
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
id
BG000
title
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
description
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
id
BG001
title
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
id
BG002
title
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
4.1
value
12.4
group Id
BG001
spread
4.3
value
9.7
group Id
BG002
spread
5.6
value
8.6
group Id
BG003
spread
5.0
value
10.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
2
group Id
BG003
value
2
title
< 2 years
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
14
title
Between 2 and 6 years
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
18
title
Between 7 and 11 years
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
7
group Id
BG002
value
7
group Id
BG003
value
23
title
Between 12 and 18 years
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
> 18 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
8
group Id
BG003
value
19
title
Female
measurements
group Id
BG000
value
11
group Id
BG001
value
12
group Id
BG002
value
16
group Id
BG003
value
39
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
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Not Hispanic or Latino
measurements
group Id
BG000
value
17
group Id
BG001
value
16
group Id
BG002
value
24
group Id
BG003
value
57
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
16
group Id
BG001
value
15
group Id
BG002
value
21
group Id
BG003
value
52
title
White
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Black/African American
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Other
description
Race only
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice