Trial Outcomes & Findings for Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia (NCT NCT00306202)

NCT ID: NCT00306202

Last Updated: 2021-02-26

Results Overview

The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 63 participants
• Primary outcome timeframe: From the date of first dose to end-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])
• Results posted on: 2021-02-26

Participant Flow

Participant milestones

Measure	Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 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.	Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 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.	Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 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.
Overall Study STARTED	17	17	24
Overall Study COMPLETED	17	17	24
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Baseline characteristics by cohort

Measure	Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose n=17 Participants 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.	Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose n=17 Participants 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.	Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose n=24 Participants 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.	Total n=58 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 4.1 • n=5 Participants	9.7 years STANDARD_DEVIATION 4.3 • n=7 Participants	8.6 years STANDARD_DEVIATION 5.6 • n=5 Participants	10.0 years STANDARD_DEVIATION 5.0 • n=4 Participants
Age, Customized < 2 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Age, Customized Between 2 and 6 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Age, Customized Between 7 and 11 years	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Age, Customized Between 12 and 18 years	9 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Age, Customized > 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	39 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants	57 Participants n=4 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	52 Participants n=4 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: From the date of first dose to end-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])

Population: All treated participants: Participants who received at least 1 dose of study therapy

The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=24 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia	80 mg/m^2 QD	NA mg/m^2 QD Phase II dose was not chosen for this population as there is no current plan to move forward with development in this population due to lack of efficacy despite escalations to the highest dose of 120 mg/m\^2 in this trial.	—	60 mg/m^2 QD	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first dose until at least 30 days after the last dose of study drug (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])

Population: All treated participants: Participants who received at least 1 dose of study therapy.

AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3 = Severe; Grade 4 = Life-threatening or disabling.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.	Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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.
Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. Drug-Related Deaths	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. Drug-Related SAEs	1 participants	2 participants	3 participants	1 participants	2 participants	2 participants	2 participants	2 participants
Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. Drug-Related AEs Leading to Discontinuation	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. Grade 3/4 AEs	3 participants	4 participants	3 participants	5 participants	3 participants	4 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: From the date of first dose until at least 30 days after the last dose of study drug (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])

Population: All treated participants: Participants who received at least 1 dose of study therapy.

DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:- --Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days --GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution --Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.	Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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.
Number of Participants With Dose-limiting Toxicity (DLT)	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 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])

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

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.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.	Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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.
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 WBC GR1	4 participants	2 participants	1 participants	6 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 WBC GR2	1 participants	3 participants	3 participants	0 participants	0 participants	1 participants	1 participants	1 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 WBC GR3	0 participants	0 participants	1 participants	0 participants	0 participants	2 participants	1 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 WBC GR4	0 participants	1 participants	3 participants	0 participants	2 participants	2 participants	3 participants	1 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 ANC GR1	3 participants	1 participants	1 participants	3 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 ANC GR2	0 participants	2 participants	2 participants	4 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 ANC GR3	2 participants	2 participants	0 participants	1 participants	0 participants	2 participants	0 participants	2 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 ANC GR4	1 participants	3 participants	4 participants	0 participants	4 participants	4 participants	6 participants	3 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Platelet GR1	4 participants	0 participants	2 participants	4 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Platelet GR2	1 participants	0 participants	2 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Platelet GR3	0 participants	4 participants	1 participants	2 participants	0 participants	1 participants	1 participants	1 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Platelet GR4	0 participants	4 participants	3 participants	0 participants	4 participants	5 participants	5 participants	5 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Hemoglobin GR1	4 participants	1 participants	0 participants	3 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Hemoglobin GR2	1 participants	5 participants	3 participants	4 participants	2 participants	3 participants	3 participants	3 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Hemoglobin GR3	0 participants	1 participants	4 participants	0 participants	3 participants	1 participants	3 participants	2 participants
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 Hemoglobin GR4	0 participants	1 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 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])

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

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. Low calcium: GR1=<LLN-8.0 mg/dL, GR2=<8.0-7.0 mg/dL, GR3=<7.0-6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN-1.2 mg/dL, GR2=<1.2-0.9 mg/dL, GR3=<0.9-0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN - 2.5 mg/dL, GR2=<2.5 - 2.0 mg/dL, GR3=<2.0 - 1.0 mg/dL, GR4=<1.0 mg/dL.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.	Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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.
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Calcium GR4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low magnesium GR1	1 participants	5 participants	0 participants	1 participants	1 participants	0 participants	4 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Magnesium GR2	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Magnesium GR3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Magnesium GR4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Phosphate GR1	1 participants	2 participants	2 participants	2 participants	0 participants	2 participants	2 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Phosphate GR2	0 participants	0 participants	1 participants	1 participants	0 participants	2 participants	1 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Phosphate GR3	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Phosphate GR4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Calcium GR1	0 participants	2 participants	2 participants	3 participants	2 participants	0 participants	1 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Calcium GR2	0 participants	1 participants	1 participants	0 participants	0 participants	2 participants	2 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 Low Calcium GR3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 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])

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

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.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.	Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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) n=6 Participants 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.
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 AST GR1	3 participants	5 participants	3 participants	1 participants	1 participants	4 participants	2 participants	2 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 AST GR2	0 participants	2 participants	1 participants	0 participants	1 participants	1 participants	1 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 AST GR3	0 participants	1 participants	2 participants	0 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 AST GR4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High ALT GR1	4 participants	4 participants	2 participants	4 participants	0 participants	2 participants	3 participants	2 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High ALT GR2	0 participants	2 participants	1 participants	0 participants	1 participants	2 participants	1 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High ALT GR3	0 participants	1 participants	0 participants	0 participants	1 participants	2 participants	0 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High ALT GR4	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 Total Bilirubin GR1	0 participants	1 participants	1 participants	2 participants	0 participants	1 participants	2 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 Total Bilirubin GR2	1 participants	0 participants	0 participants	0 participants	1 participants	2 participants	1 participants	1 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 Total Bilirubin GR3	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 Total Bilirubin GR4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High Serum Creatinine GR1	1 participants	1 participants	1 participants	1 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High Serum Creatinine GR3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High Serum Creatinine GR2	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 High Serum Creatinine GR4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (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])

Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.

Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)	6 participants	4 participants	7 participants	9 participants	—	—	—	—

SECONDARY outcome

Timeframe: After completion of Week 12 and 24 (measured at Weeks 13 and 25)

Population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.

Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks MCyR within first 12 weeks	2 participants	—	—	6 participants	—	—	—	—
Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks MCyR within first 24 weeks	5 participants	—	—	9 participants	—	—	—	—

SECONDARY outcome

Timeframe: Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (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])

Population: All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy. Stratum 2/3 dasatinib 80 mg/m\^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study.

Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample. Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:>65%-95% Ph+ cells in metaphase in BM. No CyR:>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases [%Ph+ <100%]).

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) No Response (>95% - 100%)	0 participants	0 participants	1 participants	1 participants	—	—	—	—
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) Minimal (>65% - 95%)	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) Minor (>35% - 65%)	0 participants	0 participants	0 participants	1 participants	—	—	—	—
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) Partial (>0% - 35%)	0 participants	0 participants	0 participants	1 participants	—	—	—	—
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) Complete (0%)	6 participants	4 participants	8 participants	8 participants	—	—	—	—
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) Unable to determine	0 participants	4 participants	0 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (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])

Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.

Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose CCyR	88.9 percentage of participants Interval 51.8 to 99.7	—	—	72.7 percentage of participants Interval 39.0 to 94.0	—	—	—	—
Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose MCyR	88.9 percentage of participants Interval 51.8 to 99.7	—	—	81.8 percentage of participants Interval 48.2 to 97.7	—	—	—	—

SECONDARY outcome

Timeframe: Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days).

Population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders.

Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=12 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=15 Participants Dasatinib 60 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.
Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)	33.5 days Interval 22.0 to 43.0	—	—	75.0 days Interval 43.0 to 92.0	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months)

Population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.

Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best responses were MCyR and CCyR respectively). MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=12 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=15 Participants Dasatinib 60 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.
Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])	4.6 months Interval 1.2 to 17.4	—	—	52.2 months Interval 10.0 to 56.1	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)

Population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.

Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best response was CCyR). CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=12 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=14 Participants Dasatinib 60 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.
Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]	4.6 months Interval 1.2 to 17.4	—	—	48.1 months Interval 10.0 to 56.1	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])

Population: All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.

Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp). Criteria: CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm^3 ≤platelet <100,000/mm^3 & /or 500/mm^3 ≤ANC ≤1000/mm^3.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=8 Participants Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.	Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) n=6 Participants 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) n=6 Participants 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.
Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)	6 participants	0 participants	0 participants	2 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: After completion of Week 6 and 24 (measured at weeks 7 and 25)

Population: All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.

Defined as participants having as best response a CHR or CHRp. Criteria: CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm^3 ≤platelet <100,000/mm^3 and /or 500/mm^3 ≤ANC ≤1000/mm^3.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=8 Participants Dasatinib 60 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.
Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks MaHR within first 6 weeks	5 participants	—	—	2 participants	—	—	—	—
Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks MaHR within first 24 weeks	6 participants	—	—	2 participants	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])

Population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.

HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR): WBC in PB: <10,000/mm^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) <5%; Basophils in PB: <5%; Platelet count (untransfused): <450,000/mm^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly. Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) Best Confirmed HR-Complete	6 participants	—	—	10 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) Best Confirmed HR-No Response	0 participants	—	—	1 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) Best Unconfirmed Hematologic Response-Complete	6 participants	—	—	10 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) Best Unconfirmed Hematologic Response-No Response	0 participants	—	—	1 participants	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])

Population: All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.

HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM. Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=8 Participants Dasatinib 60 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.
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) Best Confirmed HR-Complete	5 participants	—	—	1 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) Best Confirmed HR-Complete except periph. recovery	1 participants	—	—	1 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) Best Confirmed HR-No Response	3 participants	—	—	6 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) Best Unconfirmed HR-Complete	7 participants	—	—	3 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) Best Unconfirmed HR-Minor	1 participants	—	—	0 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) Best Unconfirmed HR-No Response	1 participants	—	—	5 participants	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])

Population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.

HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=6 Participants Dasatinib 60 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.
Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) Best Unconfirmed HR-No Response	6 participants	6 participants	6 participants	5 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) Best Confirmed HR-No Response	6 participants	6 participants	6 participants	5 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) Best Confirmed HR-Unable to Determine	0 participants	0 participants	0 participants	1 participants	—	—	—	—
Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) Best Unconfirmed HR-Unable to Determine	0 participants	0 participants	0 participants	1 participants	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days).

Population: Treated participants with MaHR in stratum 2/3.

Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval. MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=8 Participants Dasatinib 60 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.
Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)	—	—	—	36.0 days Interval 29.0 to 42.0	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).

Population: All treated participants with CHR in strata 1 and 2/3.

Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval. Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3. Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=16 Participants Dasatinib 60 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.
Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)	39.5 days Interval 36.0 to 44.0	—	—	21.5 days Interval 16.0 to 23.0	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months).

Population: All treated participants with MaHR in stratum 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.

Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed. MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=8 Participants Dasatinib 60 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.
Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)	—	—	—	4.4 months Interval 3.5 to Upper limit could not be derived with the method of Brookmeyer and Crowley.	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months).

Population: Treated participants with CHR in strata 1 and 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.

Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3). The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=16 Participants Dasatinib 60 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.
Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)	7.3 months Interval 3.5 to Upper limit could not be derived with the method of Brookmeyer and Crowley.	—	—	NA months Interval 14.3 to Median duration of CHR was not estimable as only 5 participants had disease progression and more than 50% of participants were censored.	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])

Population: All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m\^2.

A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR. The Clopper and Pearson method was used to compute 95% exact CIs.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)	—	—	—	90.9 percentage of participants Interval 58.7 to 99.8	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])

Population: All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m\^2.

A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR). Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=9 Participants Dasatinib 60 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.
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) CHR	—	—	—	55.6 percentage of participants Interval 21.2 to 86.3	—	—	—	—
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) MaHR	—	—	—	66.7 percentage of participants Interval 29.9 to 92.5	—	—	—	—
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) OHR	—	—	—	66.7 percentage of participants Interval 29.9 to 92.5	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])

Population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.

Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay. Major molecular response (MMR): Ratio of the BCR-ABL to ABL <10^-3 or 0.1% on the international scale. Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is <10^-4.5 or 0.00316% on the international scale. Confirmed MMR or CMR = Criteria met again >6 weeks. BCR-ABL=the fused gene found in participants with this type of CML.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=11 Participants Dasatinib 60 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.
Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) MMR (Overall)	2 participants	—	—	6 participants	—	—	—	—
Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) CMR (Unconfirmed)	1 participants	—	—	3 participants	—	—	—	—
Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) CMR (Confirmed)	0 participants	—	—	1 participants	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])

Population: All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.

Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay. MMR: Ratio of the BCR-ABL to ABL <10^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL <10^-3 on the international scale in participants with p210 variant. BCR-ABL=the fused gene found in participants with this type of CML.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=8 Participants Dasatinib 60 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.
Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)	6 participants	—	—	2 participants	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization to date of progression, death, last tumor assessment, or 5 years after 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])

Population: All treated participants: Participants who received at least 1 dose of study therapy. If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported.

Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator. Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=24 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Progression Free Survival (PFS)	4.9 months Interval 0.6 to 8.4	1.4 months Interval 0.4 to 1.6	—	53.6 months Interval 11.4 to Upper limit not reached	—	—	—	—

SECONDARY outcome

Timeframe: From start of study therapy until death or 5 years after 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])

Population: All treated participants: Participants who received at least 1 dose of study therapy. Participants lost to followup were censored on the last date the participant was known to be alive.

Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=24 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Overall Survival (OS)	8.6 months Interval 3.2 to Upper limit not reached	3.0 months Interval 1.7 to 4.4	—	NA months Median OS was not estimable as 14 of the 17 participants were censored by 25 May 2011	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=53 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group Infants and Toddlers (age<2 years old; n=2)	—	—	—	0.5 hours Full Range 0.0 • Interval 0.5 to 0.5	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group Children (age>=2 and <12 years old; n=43)	—	—	—	1.1 hours Full Range 58.6 • Interval 0.5 to 4.1	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group Adolescents (age>=12 and <18 years old; n=28)	—	—	—	1.0 hours Full Range 82.2 • Interval 0.5 to 6.0	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group Above 18 Years (n=1)	—	—	—	0.9 hours Full Range NA • Interval 0.9 to 0.9	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group Total (n=74)	—	—	—	1.0 hours Full Range 70.9 • Interval 0.5 to 6.0	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=53 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group Infants and Toddlers (age<2 years old; n=2)	—	—	—	2.1 hours Geometric Coefficient of Variation 24.0	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group Children (age>=2 and <12 years old; n=36)	—	—	—	3.0 hours Geometric Coefficient of Variation 62.8	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group Adolescents (age>=12 and <18 years old; n=22)	—	—	—	3.8 hours Geometric Coefficient of Variation 43.9	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group Above 18 years (n=1)	—	—	—	7.3 hours Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group Total (n=61)	—	—	—	3.3 hours Geometric Coefficient of Variation 55.7	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=53 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group Infants and Toddlers (age<2 years old; n=2)	—	—	—	1.0 ng/mL/mg/m^2 Geometric Coefficient of Variation 15.2	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group Children (age>=2 and <12 years old; n=43)	—	—	—	1.9 ng/mL/mg/m^2 Geometric Coefficient of Variation 79.9	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group Adolescents (age>=12 and <18 years old; n=28)	—	—	—	1.0 ng/mL/mg/m^2 Geometric Coefficient of Variation 69.7	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group Above 18 Years (n=1)	—	—	—	0.9 ng/mL/mg/m^2 Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group Total (n=74)	—	—	—	1.5 ng/mL/mg/m^2 Geometric Coefficient of Variation 86.9	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-T] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=53 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group Infants and Toddlers (age<2 years old; n=2)	—	—	—	2.8 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 4.6	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group Children (age>=2 and <12 years old; n=40)	—	—	—	6.1 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 95.7	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group Adolescents (age>=12 and <18 years old; n=28)	—	—	—	3.8 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 66.8	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group Above 18 Years (n=1)	—	—	—	2.2 ng.h/mL/mg/m^2 Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group Total (n=71)	—	—	—	4.9 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 98.1	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=53 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group Infants and Toddlers (age<2 years old; n=2)	—	—	—	3.2 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 17.7	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group Children (age>=2 and <12 years old; n=36)	—	—	—	6.7 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 95.0	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group Adolescents (age>=12 and <18 years old; n=22)	—	—	—	4.2 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 67.6	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group Above 18 Years (n=1)	—	—	—	2.4 ng.h/mL/mg/m^2 Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group Total (n=61)	—	—	—	5.4 ng.h/mL/mg/m^2 Geometric Coefficient of Variation 97.1	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=25 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=19 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=10 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=20 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Infants and Toddlers (age>2yr; n=0; n=0; n=1; n=1)	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	30.6 ng/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	53.8 ng/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Children (age>=2 & <12yr; n=11; n=16; n=9; n=7)	142.5 ng/mL Geometric Coefficient of Variation 80.2	111.2 ng/mL Geometric Coefficient of Variation 82.6	208.4 ng/mL Geometric Coefficient of Variation 78.5	110.6 ng/mL Geometric Coefficient of Variation 61.8	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Adolescents (age>=12; n=9; n=8; n=9; n=2)	116.5 ng/mL Geometric Coefficient of Variation 73.0	235.1 ng/mL Geometric Coefficient of Variation 59.0	123.3 ng/mL Geometric Coefficient of Variation 68.3	92.6 ng/mL Geometric Coefficient of Variation 50.6	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	143.2 ng/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Total	133.6 ng/mL Geometric Coefficient of Variation 77.6	148.1 ng/mL Geometric Coefficient of Variation 75.0	163.9 ng/mL Geometric Coefficient of Variation 87.6	102.1 ng/mL Geometric Coefficient of Variation 58.0	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=25 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=19 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=10 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=20 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)	NA hour No participants in this age group.	0.5 hour Interval 0.5 to 0.5	0.5 hour Interval 0.5 to 0.5	NA hour Full Range NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Children (age>=2 & <12yr; n=11; n=16; n=9; n=7)	1.5 hour Interval 0.5 to 3.2	1.1 hour Interval 0.6 to 4.1	1.0 hour Interval 0.9 to 2.2	1.1 hour Full Range 61.8 • Interval 0.5 to 2.1	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Adolescents (age>=12 & <12yr; n=9; n=8; n=9; n=2)	1.1 hour Interval 0.5 to 4.0	1.0 hour Interval 0.5 to 6.0	1.6 hour Interval 1.0 to 2.1	1.0 hour Interval 0.5 to 4.0	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	0.9 hour Interval 0.9 to 0.9	NA hour No participants in this age group.	NA hour No participants in this age group.	NA hour No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Total	1.1 hour Interval 0.5 to 4.0	1.0 hour Interval 0.5 to 6.0	1.0 hour Interval 0.5 to 2.2	1.0 hour Interval 0.5 to 4.0	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=25 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=18 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=19 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	367.2 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Total	484.3 ng.h/mL Geometric Coefficient of Variation 88.9	504.1 ng.h/mL Geometric Coefficient of Variation 89.6	534.9 ng.h/mL Geometric Coefficient of Variation 103.9	307.0 ng.h/mL Geometric Coefficient of Variation 60.2	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	100.8 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	134.9 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Children (age>=2 & <12yr; n=10; n=16; n=8; n=6)	490.8 ng.h/mL Geometric Coefficient of Variation 96.7	373.5 ng.h/mL Geometric Coefficient of Variation 82.0	676.7 ng.h/mL Geometric Coefficient of Variation 99.9	295.0 ng.h/mL Geometric Coefficient of Variation 63.5	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2)	488.1 ng.h/mL Geometric Coefficient of Variation 35.0	787.0 ng.h/mL Geometric Coefficient of Variation 76.2	526.1 ng.h/mL Geometric Coefficient of Variation 56.6	320.8 ng.h/mL Geometric Coefficient of Variation 59.1	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=20 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=15 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=18 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)	0 ng.h/mL Geometric Coefficient of Variation 0	127.7 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	142.1 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	0 ng.h/mL Geometric Coefficient of Variation 0	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group Children (age>=2 & <12yr; n=10; n=14; n=7; n=5)	513.6 ng.h/mL Geometric Coefficient of Variation 99.2	429.1 ng.h/mL Geometric Coefficient of Variation 76.8	817.6 ng.h/mL Geometric Coefficient of Variation 93.7	313.9 ng.h/mL Geometric Coefficient of Variation 59.8	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2)	605.1 ng.h/mL Geometric Coefficient of Variation 25.3	1008.9 ng.h/mL Geometric Coefficient of Variation 69.4	547.8 ng.h/mL Geometric Coefficient of Variation 58.2	305.8 ng.h/mL Geometric Coefficient of Variation 60.9	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	390.0 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	0 ng.h/mL Geometric Coefficient of Variation 0	0 ng.h/mL Geometric Coefficient of Variation 0	0 ng.h/mL Geometric Coefficient of Variation 0	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group Total	527.8 ng.h/mL Geometric Coefficient of Variation 90.4	589.8 ng.h/mL Geometric Coefficient of Variation 86.2	594.4 ng.h/mL Geometric Coefficient of Variation 101.5	310.3 ng.h/mL Geometric Coefficient of Variation 58.6	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=20 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=15 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=8 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=18 Participants Dasatinib 60 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.
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)	NA hour Standard Deviation NA No participants in this age group.	2.5 hour Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	1.8 hour Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA hour Standard Deviation NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group Children (age>=2 & <12yr; n=10; n=14; n=7; n=5)	3.9 hour Standard Deviation 1.9	4.6 hour Standard Deviation 3.5	3.2 hour Standard Deviation 1.9	2.4 hour Standard Deviation 1.0	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2)	5.1 hour Standard Deviation 0.5	4.5 hour Standard Deviation 2.5	3.5 hour Standard Deviation 2.9	3.7 hour Standard Deviation 1.6	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	7.3 hour Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA hour Standard Deviation NA No participants in this age group.	NA hour Standard Deviation NA No participants in this age group.	NA hour Standard Deviation NA No participants in this age group.	—	—	—	—
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group Total	4.4 hour Standard Deviation 1.8	4.4 hour Standard Deviation 2.9	3.1 hour Standard Deviation 1.9	3.0 hour Standard Deviation 1.4	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=25 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=16 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=10 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=18 Participants Dasatinib 60 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.
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1)	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	1.2 ng/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Children (age>=2 & <12yr; n=10; n=16; n=7; n=7)	3.4 ng/mL Geometric Coefficient of Variation 82.0	6.0 ng/mL Geometric Coefficient of Variation 69.3	4.8 ng/mL Geometric Coefficient of Variation 65.3	3.6 ng/mL Geometric Coefficient of Variation 46.4	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Adolescents (age>=12 & <18yr; n=8; n=8; n=9; n=2)	3.6 ng/mL Geometric Coefficient of Variation 56.7	6.9 ng/mL Geometric Coefficient of Variation 75.0	4.3 ng/mL Geometric Coefficient of Variation 77.9	3.1 ng/mL Geometric Coefficient of Variation 40.3	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	2.2 ng/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group Total	3.4 ng/mL Geometric Coefficient of Variation 74.4	6.5 ng/mL Geometric Coefficient of Variation 72.0	4.1 ng/mL Geometric Coefficient of Variation 70.8	3.4 ng/mL Geometric Coefficient of Variation 43.7	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=25 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=16 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=10 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=18 Participants Dasatinib 60 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.
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1)	NA hour No participants in this age group.	NA hour No participants in this age group.	0.9 hour Interval 0.9 to 0.9	NA hour No participants in this age group.	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Children (age>=2 & <12yr; n=10; n=16; n=7; n=7)	2.0 hour Interval 0.5 to 6.0	2.1 hour Interval 1.0 to 4.1	2.0 hour Interval 1.0 to 2.2	2.0 hour Interval 1.0 to 4.5	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2)	2.0 hour Interval 1.0 to 4.0	2.0 hour Interval 1.0 to 8.1	2.1 hour Interval 2.0 to 2.1	2.0 hour Interval 1.0 to 4.0	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	0.9 hour Interval 0.9 to 0.9	NA hour No participants in this age group.	NA hour No participants in this age group.	NA hour No participants in this age group.	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group Total	2.0 hour Interval 0.5 to 6.0	2.0 hour Interval 1.0 to 8.1	2.0 hour Interval 0.9 to 2.2	2.0 hour Interval 1.0 to 4.5	—	—	—	—

SECONDARY outcome

Timeframe: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=21 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=14 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=9 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=13 Participants Dasatinib 60 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.
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1)	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	1.9 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Children (age>=2 & <12yr; n=7; n=12; n=5; n=6)	16.6 ng.h/mL Geometric Coefficient of Variation 145.2	25.4 ng.h/mL Geometric Coefficient of Variation 71.1	23.6 ng.h/mL Geometric Coefficient of Variation 102.2	8.8 ng.h/mL Geometric Coefficient of Variation 50.4	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Adolescents (age>=12 & <12yr; n=6; n=8; n=9; n=2)	13.5 ng.h/mL Geometric Coefficient of Variation 54.4	20.0 ng.h/mL Geometric Coefficient of Variation 112.3	15.8 ng.h/mL Geometric Coefficient of Variation 105.5	12.3 ng.h/mL Geometric Coefficient of Variation 38.4	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Above 18 years (n=0; n=1; n=0; n=0)	6.6 ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng.h/mL Geometric Coefficient of Variation NA No participants in this age group.	NA ng.h/mL Geometric Coefficient of Variation NA Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.	—	—	—	—
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group Total	14.7 ng.h/mL Geometric Coefficient of Variation 141.1	21.8 ng.h/mL Geometric Coefficient of Variation 100.1	16.3 ng.h/mL Geometric Coefficient of Variation 110.3	10.3 ng.h/mL Geometric Coefficient of Variation 44.9	—	—	—	—

SECONDARY outcome

Timeframe: 4 hours after oral dose

Population: All treated participants with CSF samples available. n=number of PK parameters included. Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated.

Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment. y=years

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=10 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=6 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 n=1 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=4 Participants Dasatinib 60 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.
Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group Children (age>=2 & <12 y; n=3, n=9, n=3, n=1)	1.5 ng/mL Standard Deviation 0.6	1.7 ng/mL Standard Deviation 0.4	3.8 ng/mL Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.	1.1 ng/mL Standard Deviation 0.2	—	—	—	—
Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0)	1.0 ng/mL Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.	2.6 ng/mL Standard Deviation 0.6	NA ng/mL Standard Deviation NA No participants in this age group.	1.1 ng/mL Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.	—	—	—	—
Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group Total (Children + Adolescents;n=4; n=10; n=6; n=1)	1.4 ng/mL Standard Deviation 0.6	2.1 ng/mL Standard Deviation 0.7	3.8 ng/mL Standard Deviation NA Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.	1.1 ng/mL Standard Deviation 0.1	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (within 3 weeks before initiation of study therapy)

Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.

BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML L384M	0 participants	—	—	1 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML G250E	0 participants	—	—	1 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML T315I	1 participants	—	—	0 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML Y253H	1 participants	—	—	0 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML Y253F	1 participants	—	—	0 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML No Mutation	11 participants	—	—	15 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML No Data	3 participants	—	—	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: At 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])

Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.

BCR-ABL = These are fused genes found in participants with this type of leukemia.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML T315I	4 participants	—	—	0 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML No Mutation	9 participants	—	—	8 participants	—	—	—	—
Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML No Data	4 participants	—	—	9 participants	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (within 3 weeks before initiation of study therapy)

Population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.

FLT3 and KIT = These are fused genes found in participants with this type of leukemia.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=24 Participants Dasatinib 60 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.
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline FLT3 Absent	—	—	—	20 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline FLT3 Present	—	—	—	1 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline FLT3 No Data	—	—	—	3 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline KIT Absent	—	—	—	21 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline KIT Present	—	—	—	0 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline KIT No Data	—	—	—	3 participants	—	—	—	—

SECONDARY outcome

Timeframe: At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])

Population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.

FLT3 and KIT = These are fused genes found in participants with this type of leukemia.

Outcome measures

Measure	Dasatinib 80 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=24 Participants Dasatinib 60 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.
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment FLT3 Absent	—	—	—	6 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment FLT3 Present	—	—	—	0 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment FLT3 No Data	—	—	—	18 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment KIT Absent	—	—	—	6 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment KIT Present	—	—	—	0 participants	—	—	—	—
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment KIT No Data	—	—	—	18 participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (within 1 week before initiation of study therapy)

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

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. White Blood Cell (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. Absolute Neutrophil Count (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. LLN=lower limit of normal.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=24 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 WBC GR1	2 participants	3 participants	—	1 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 WBC GR2	2 participants	2 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 WBC GR3	0 participants	6 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 WBC GR4	1 participants	4 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 ANC GR1	2 participants	3 participants	—	1 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 ANC GR2	1 participants	0 participants	—	1 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 ANC GR3	2 participants	3 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 ANC GR4	2 participants	13 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Platelet GR1	5 participants	5 participants	—	1 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Platelet GR2	2 participants	3 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Platelet GR3	3 participants	8 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Platelet GR4	2 participants	6 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Hemoglobin GR1	7 participants	7 participants	—	7 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Hemoglobin GR2	7 participants	7 participants	—	1 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Hemoglobin GR3	1 participants	3 participants	—	0 participants	—	—	—	—
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 Hemoglobin GR4	0 participants	0 participants	—	0 participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (within 1 week before initiation of study therapy)

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

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. Aspartate aminotransferase (AST) and alanine aminotransferase(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. ULN=upper limit of normal.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=24 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 AST GR1	3 participants	8 participants	—	1 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 AST GR2	2 participants	1 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 AST GR3	1 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 AST GR4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 AST GR Not Reported	3 participants	2 participants	—	1 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High ALT GR1	6 participants	6 participants	—	2 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High ALT GR2	2 participants	5 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High ALT GR3	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High ALT GR4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High ALT GR Not Reported	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Total Bilirubin GR1	0 participants	1 participants	—	3 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Total Bilirubin GR2	1 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Total Bilirubin GR3	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Total Bilirubin G4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Total Bilirubin GR Not Reported	0 participants	1 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Serum Creatinine GR1	0 participants	4 participants	—	2 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Serum Creatinine GR2	1 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Serum Creatinine GR3	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Serum Creatinine GR4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 High Serum Creatinine GR Not Reported	0 participants	1 participants	—	0 participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (within 1 week before initiation of study therapy)

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

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. Low calcium: GR1=<LLN-8.0 mg/dL, GR2=<8.0-7.0 mg/dL, GR3=<7.0-6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN-1.2 mg/dL, GR2=<1.2-0.9 mg/dL, GR3=<0.9-0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN - 2.5 mg/dL, GR2=<2.5 - 2.0 mg/dL, GR3=<2.0 - 1.0 mg/dL, GR4=<1.0 mg/dL.

Outcome measures

Measure	Dasatinib 80 mg/m^2 n=17 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 100 mg/m^2 n=24 Participants Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 120 mg/m^2 Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.	Dasatinib 60 mg/m^2 n=17 Participants Dasatinib 60 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.
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Calcium GR1	0 participants	1 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Calcium GR2	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Calcium GR3	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Calcium GR4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Calcium GR Not Reported	0 participants	2 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Magnesium GR1	6 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Magnesium GR2	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Magnesium GR3	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Magnesium GR4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Magnesium GR Not Reported	0 participants	2 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Phosphate GR1	1 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Phosphate GR2	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Phosphate GR3	1 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Phosphate GR4	0 participants	0 participants	—	0 participants	—	—	—	—
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Low Phosphate GR Not Reported	0 participants	2 participants	—	2 participants	—	—	—	—

Adverse Events

Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose

Serious events: 8 serious events

Other events: 16 other events

Deaths: 0 deaths

Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose

Serious events: 14 serious events

Other events: 16 other events

Deaths: 0 deaths

Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose

Serious events: 22 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose n=17 participants at risk 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.	Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose n=17 participants at risk 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.	Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose n=24 participants at risk 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.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	20.8% 5/24 • From first dose to 100 days post last dose
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Cardiac disorders Palpitations	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Abdominal pain	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Ascites	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Colitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Enterocolitis	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Ileus	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Nausea	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Pancreatitis	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Stomatitis	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Vomiting	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Multiple organ dysfunction syndrome	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Pain	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
General disorders Performance status decreased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Pyrexia	5.9% 1/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	16.7% 4/24 • From first dose to 100 days post last dose
Immune system disorders Anaphylactic shock	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Immune system disorders Graft versus host disease	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Immune system disorders Hypersensitivity	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Anal infection	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Bronchitis	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Cellulitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Device related infection	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Escherichia sepsis	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Febrile infection	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Gastroenteritis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Infection	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Infections and infestations Pneumonia	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Infections and infestations Sepsis	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Septic shock	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Varicella zoster virus infection	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Ammonia increased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Hepatic enzyme increased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations White blood cell count increased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Decreased appetite	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	29.2% 7/24 • From first dose to 100 days post last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Nervous system disorders Coma	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Facial nerve disorder	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Syncope	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Product Issues Thrombosis in device	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Psychiatric disorders Depression	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Renal and urinary disorders Renal failure	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Rash	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Vascular disorders Hypertension	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose

Other adverse events

Measure	Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose n=17 participants at risk 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.	Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose n=17 participants at risk 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.	Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose n=24 participants at risk 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.
Skin and subcutaneous tissue disorders Miliaria	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations White blood cell count decreased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Decreased appetite	5.9% 1/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	12.5% 3/24 • From first dose to 100 days post last dose
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Aneurysmal bone cyst	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Arthralgia	35.3% 6/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	16.7% 4/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Back pain	29.4% 5/17 • From first dose to 100 days post last dose	23.5% 4/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	16.7% 4/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Epiphyses delayed fusion	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Growth retardation	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Hypermobility syndrome	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Muscle spasms	23.5% 4/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Muscle tightness	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.8% 2/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Myalgia	23.5% 4/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Osteoporosis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Musculoskeletal and connective tissue disorders Pain in extremity	52.9% 9/17 • From first dose to 100 days post last dose	29.4% 5/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Disturbance in attention	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Dizziness	17.6% 3/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Nervous system disorders Facial paralysis	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Headache	64.7% 11/17 • From first dose to 100 days post last dose	29.4% 5/17 • From first dose to 100 days post last dose	25.0% 6/24 • From first dose to 100 days post last dose
Nervous system disorders Intracranial pressure increased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Neuralgia	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Nervous system disorders Post-traumatic headache	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Psychiatric disorders Agitation	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Psychiatric disorders Anxiety	0.00% 0/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Psychiatric disorders Depressed mood	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Psychiatric disorders Enuresis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Psychiatric disorders Insomnia	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Psychiatric disorders Sleep disorder	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Psychiatric disorders Suicidal ideation	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Reproductive system and breast disorders Ovarian failure	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Cough	64.7% 11/17 • From first dose to 100 days post last dose	29.4% 5/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Dry throat	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Epistaxis	11.8% 2/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	29.4% 5/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Respiratory, thoracic and mediastinal disorders Wheezing	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Acne	11.8% 2/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Dermatitis	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Dermatitis acneiform	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Dry skin	11.8% 2/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Erythema	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Hair colour changes	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Nail disorder	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Night sweats	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Pigmentation disorder	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Pruritus	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Rash	41.2% 7/17 • From first dose to 100 days post last dose	35.3% 6/17 • From first dose to 100 days post last dose	12.5% 3/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Skin disorder	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Skin and subcutaneous tissue disorders Urticaria	17.6% 3/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Vascular disorders Flushing	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Vascular disorders Hot flush	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Vascular disorders Hypertension	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Vascular disorders Thrombosis	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Blood and lymphatic system disorders Neutropenia	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Blood and lymphatic system disorders Pancytopenia	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Blood and lymphatic system disorders Splenomegaly	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	12.5% 3/24 • From first dose to 100 days post last dose
Cardiac disorders Palpitations	17.6% 3/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Ear and labyrinth disorders Ear discomfort	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Ear and labyrinth disorders Ear pain	11.8% 2/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Ear and labyrinth disorders Middle ear effusion	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Chalazion	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Dacryoadenitis acquired	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Dry eye	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Erythema of eyelid	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Eye discharge	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Eye pain	5.9% 1/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Eye pruritus	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Eye swelling	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Eyelid oedema	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Eye disorders Eyelid ptosis	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Orbital oedema	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Eye disorders Periorbital oedema	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Eye disorders Swelling of eyelid	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Abdominal discomfort	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Abdominal pain	52.9% 9/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	12.5% 3/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Abdominal pain lower	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Abdominal pain upper	17.6% 3/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Aphthous ulcer	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Colitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Constipation	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Dental caries	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Diarrhoea	64.7% 11/17 • From first dose to 100 days post last dose	41.2% 7/17 • From first dose to 100 days post last dose	25.0% 6/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Flatulence	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Gingival bleeding	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Mouth ulceration	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Nausea	41.2% 7/17 • From first dose to 100 days post last dose	35.3% 6/17 • From first dose to 100 days post last dose	54.2% 13/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Oral mucosal blistering	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Oral pain	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Periodontal disease	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Tongue disorder	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Tongue ulceration	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Tooth loss	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Toothache	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Gastrointestinal disorders Vomiting	52.9% 9/17 • From first dose to 100 days post last dose	41.2% 7/17 • From first dose to 100 days post last dose	45.8% 11/24 • From first dose to 100 days post last dose
General disorders Asthenia	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Catheter site erythema	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Catheter site haemorrhage	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Catheter site pain	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Chest pain	11.8% 2/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Chills	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Face oedema	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Fatigue	41.2% 7/17 • From first dose to 100 days post last dose	23.5% 4/17 • From first dose to 100 days post last dose	16.7% 4/24 • From first dose to 100 days post last dose
General disorders Influenza like illness	11.8% 2/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
General disorders Injection site pain	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Injection site reaction	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Malaise	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Mucosal inflammation	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Oedema	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Oedema peripheral	11.8% 2/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Pain	17.6% 3/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Peripheral swelling	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Pyrexia	29.4% 5/17 • From first dose to 100 days post last dose	47.1% 8/17 • From first dose to 100 days post last dose	33.3% 8/24 • From first dose to 100 days post last dose
General disorders Swelling	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
General disorders Swelling face	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Hepatobiliary disorders Hepatomegaly	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Hepatobiliary disorders Hepatotoxicity	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Hepatobiliary disorders Hyperbilirubinaemia	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Immune system disorders Drug hypersensitivity	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Immune system disorders Hypersensitivity	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Conjunctivitis	11.8% 2/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Conjunctivitis bacterial	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Cystitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Device related infection	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Epididymitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Eye infection	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Folliculitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Fungal skin infection	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Gastrointestinal infection	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Herpes simplex	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Herpes zoster	0.00% 0/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Infection	11.8% 2/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Infections and infestations Lice infestation	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Lower respiratory tract infection	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Molluscum contagiosum	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Nasopharyngitis	47.1% 8/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Oral fungal infection	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Oral herpes	5.9% 1/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Otitis externa	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Otitis media	5.9% 1/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Pharyngitis	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Rhinitis	17.6% 3/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	4.2% 1/24 • From first dose to 100 days post last dose
Infections and infestations Sinusitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Skin infection	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Tinea cruris	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Upper respiratory tract infection	17.6% 3/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Urinary tract infection	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Varicella	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Viral infection	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Viral rhinitis	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Infections and infestations Viral upper respiratory tract infection	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Arthropod bite	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Clavicle fracture	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Contusion	11.8% 2/17 • From first dose to 100 days post last dose	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Fall	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Head injury	11.8% 2/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Joint injury	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Ligament sprain	17.6% 3/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Mouth injury	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Post-traumatic pain	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Skin abrasion	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Skin laceration	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Sunburn	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Injury, poisoning and procedural complications Wound	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Body temperature	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Haemoglobin decreased	0.00% 0/17 • From first dose to 100 days post last dose	11.8% 2/17 • From first dose to 100 days post last dose	8.3% 2/24 • From first dose to 100 days post last dose
Investigations Heart rate increased	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Hepatic enzyme increased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Neutrophil count decreased	0.00% 0/17 • From first dose to 100 days post last dose	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose
Investigations Weight decreased	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	16.7% 4/24 • From first dose to 100 days post last dose
Investigations Weight increased	5.9% 1/17 • From first dose to 100 days post last dose	0.00% 0/17 • From first dose to 100 days post last dose	0.00% 0/24 • From first dose to 100 days post last dose

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER