Number of Participants With Hematology Abnormalities 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 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, 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. WBC: GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. ANC: GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L.
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 QD, 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
WBC GR1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
6
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)
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)
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
WBC 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)
3
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)
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)
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
WBC 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)
0
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)
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
WBC 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)
1
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)
2
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)
1
Not reported
Not reported
Not reported
Not reported
ANC GR1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
3
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)
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)
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
ANC GR2
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)
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)
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)
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
ANC 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)
2
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)
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)
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)
2
Not reported
Not reported
Not reported
Not reported
ANC 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)
1
Not reported
Not reported
Not reported
Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
3
Not reported
Not reported
Not reported
Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
4
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
4
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)
6
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
3
Not reported
Not reported
Not reported
Not reported
Platelet 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)
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
Platelet 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)
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)
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
Platelet GR3
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)
4
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)
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
Platelet 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)
4
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)
4
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
5
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
5
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
5
Not reported
Not reported
Not reported
Not reported
Hemoglobin GR1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
3
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)
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)
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
Hemoglobin GR2
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)
1
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)
2
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
3
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)
3
Not reported
Not reported
Not reported
Not reported
Hemoglobin 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)
4
Not reported
Not reported
Not reported
Not reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
3
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)
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
Hemoglobin 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)
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)
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)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
0
title
WBC GR1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
1
group Id
OG007
value
1
title
WBC GR2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
0
title
WBC GR3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
3
group Id
OG007
value
1
title
WBC GR4
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
ANC GR1
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
ANC GR2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
2
title
ANC GR3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
4
group Id
OG005
value
4
group Id
OG006
value
6
group Id
OG007
value
3
title
ANC GR4
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
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
Platelet GR1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Platelet GR2
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
1
group Id
OG007
value
1
title
Platelet GR3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
5
group Id
OG007
value
5
title
Platelet 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
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. WBC: GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. ANC: GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L.
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 QD, 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 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, 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 Hematology Abnormalities by NCI CTCAE Version 3.0
Triangle