NCT00306202 · OUTCOME

Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0

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.

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])

What was measured

GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN. Total bilirubin:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN.

Analysis population: All treated participants: Participants who received at least one dose of study therapy.

Groups in this outcome

Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2, as long as clinical benefit was maintained.

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)

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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)

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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	11
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	6
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	8
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	9
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	6
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	6
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	6
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	6

Reported measurements

AST GR1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	3	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	5	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	3	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	4	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported

AST GR2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported

AST GR3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

AST GR4

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	Not reported	Not reported	Not reported	Not reported

High ALT GR1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	4	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	4	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	4	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	3	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported

High ALT GR2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

High ALT GR3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported

High ALT GR4

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin GR1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin GR2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	2	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported

Total Bilirubin GR3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin GR4

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	Not reported	Not reported	Not reported	Not reported

High Serum Creatinine GR1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

High Serum Creatinine GR2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	1	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	0	Not reported	Not reported	Not reported	Not reported

High Serum Creatinine GR3

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	Not reported	Not reported	Not reported	Not reported

High Serum Creatinine GR4

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)	Not reported	Not reported	Not reported	Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
4
group Id
OG006
value
2
group Id
OG007
value
2
title
AST GR1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
1
group Id
OG007
value
1
title
AST GR2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
0
title
AST GR3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
AST GR4
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
4
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
3
group Id
OG007
value
2
title
High ALT GR1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
0
title
High ALT GR2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
1
title
High ALT GR3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
High ALT GR4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
2
group Id
OG007
value
0
title
Total Bilirubin GR1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
1
title
Total Bilirubin GR2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Total Bilirubin GR3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Total Bilirubin GR4

denoms

counts
group Id
OG000
value
11
group Id
OG001
value
6
group Id
OG002
value
8
group Id
OG003
value
9
group Id
OG004
value
6
group Id
OG005
value
6
group Id
OG006
value
6
group Id
OG007
value
6
units
Participants

description

groups

description
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG000
title
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
description
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2, as long as clinical benefit was maintained.
id
OG001
title
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG002
title
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG003
title
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG004
title
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG005
title
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG006
title
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
id
OG007
title
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)

param Type

NUMBER

population Description

All treated participants: Participants who received at least one dose of study therapy.

reporting Status

POSTED

time Frame

Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])

title

Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice