A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00777036

Collaborator

(none)

145

Enrollment

Locations

Arms

164.9

Anticipated Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: Dasatinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Actual Study Start Date :

Mar 20, 2009

Actual Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Dec 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: Imatinib-resistant/intolerant CP-CML Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit	Drug: Dasatinib Other Names: Sprycel (BMS-354825)
Experimental: Cohort 2: Ph+ALL or AP- or BP-CML Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit	Drug: Dasatinib Other Names: Sprycel (BMS-354825)
Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit	Drug: Dasatinib Other Names: Sprycel (BMS-354825)

Arm

Intervention/Treatment

Experimental: Cohort 1: Imatinib-resistant/intolerant CP-CML

Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib

Other Names:

Sprycel (BMS-354825)

Experimental: Cohort 2: Ph+ALL or AP- or BP-CML

Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib

Other Names:

Sprycel (BMS-354825)

Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML

Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib

Other Names:

Sprycel (BMS-354825)

Outcome Measures

Primary Outcome Measures

Major Cytogenetic Response (MCyR) Rate [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]
Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Complete Hematologic Response (CHR) Rate [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]
Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Complete Cytogenetic Response (CCyR) Rate [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.

Secondary Outcome Measures

Major Cytogenetic Response (MCyR) Rate in Cohort 2 [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]
Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]
Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.
Rate of Best Cytogenetic Response [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]
The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on >=20 Metaphases)
Time to Major Cytogenetic Response (MCyR) [From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)]
Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on >=20 Metaphases)
Duration of Major Cytogenetic Response (MCyR) [From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)]
Duration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)
Time to Complete Cytogenetic Response (CCyR) [From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)]
Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on >=20 Metaphases)
Duration of Complete Cytogenetic Response (CCyR) [From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)]
Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)
Progression-Free Survival (PFS) Rate at 2 Years [2 years]
PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir -Death from any case during treatment
Time to Complete Hematologic Response (CHR) [From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)]
Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
Duration of Complete Hemotologic Response (CHR) [From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)]
Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.
Disease-Free Survival Rate at 2 Years [2 years]
Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)
Overall Survival (OS) Rate at 2 Years [2 years]
OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.
Major Molecular Response (MMR) Rate [From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)]
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.
Complete Molecular Response (CMR) Rate [From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)]
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Major Cytogenetic Response (MCyR) Rate up to 2 Years [24 months]
Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.
Complete Cytogenetic Response (CCyR) Rate up to 2 Years [24 months]
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
Major Molecular Response (MMR) Rate up to 2 Years [24 months]
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
Complete Molecular Response (CMR) Rate up to 2 Years [24 months]
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

CP-CML who prove resistant or intolerant to imatinib (Cohort 1)
Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)
Newly diagnosed, treatment naive CP-CML (Cohort 3)
Lansky or Karnofsky scale >50
Life expectancy ≥12 weeks
Adequate hepatic and renal function
Written informed consent
Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
Target Population for the PK substudy subjects must meet relevant inclusion criteria

Exclusion Criteria:

Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
Isolated extramedullary disease
Prior therapy with Dasatinib
Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

Other inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Birmingham	Alabama	United States	35233
2	Phoenix Children'S Hospital	Phoenix	Arizona	United States	85016
3	Jonathan Jaques Children'S Cancer Center	Long Beach	California	United States	90801-1428
4	Jonathan Jaques Children'S Cancer Center	Long Beach	California	United States	90806
5	Children'S Hospital Of Orange County	Orange	California	United States	92868
6	Children'S Hospital	Aurora	Colorado	United States	80045
7	Children's Healthcare Of Atlanta - Egleston	Atlanta	Georgia	United States	30322
8	Children's Hospital of Chicago	Chicago	Illinois	United States	60611
9	Local Institution	Chicago	Illinois	United States	60611
10	Dana Faber Cancer Institute	Boston	Massachusetts	United States	02215
11	Dana Farber Cancer Institute.	Boston	Massachusetts	United States	02215
12	Stephen D. Hassenfeld Children'S Center	New York	New York	United States	10016
13	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
14	Memorial Sloan Kettering Nassau	New York	New York	United States	10065
15	Oregon Health & Sci Univ	Portland	Oregon	United States	97239-3098
16	Oregon Health & Sci Univ	Portland	Oregon	United States	97239
17	Children'S Hospital Of Philadelphia	Philadelphia	Pennsylvania	United States	19104-4318
18	Children'S Hospital Of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
19	MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
20	Texas Children'S Cancer Center	Houston	Texas	United States	77030
21	Seattle Children'S	Seattle	Washington	United States	98105
22	Local Institution	Bunos Aires	Buenos Aires	Argentina	1425
23	Hospital Nacional Profesor Alejandro Posadas	El Palomar	Buenos Aires	Argentina	1684
24	Local Institution	Cordoba		Argentina	5016
25	Local Institution	Randwick	New South Wales	Australia	2031
26	Local Institution	Westmead	New South Wales	Australia	2145
27	Local Institution	Sth Brisbane	Queensland	Australia	4101
28	Local Institution	North Adelaide	South Australia	Australia	5006
29	Local Institution	Parkville	Victoria	Australia	3052
30	Local Institution	Curitiba	Parana	Brazil	80060-900
31	Local Institution	Porto Alegre	Rio Grande Do Sul	Brazil	90035-003
32	Local Institution	Campinas		Brazil	13083-970
33	Local Institution	Sao Paulo		Brazil	01401-000
34	Local Institution	Sao Paulo		Brazil	04023-062
35	Alberta Children'S Hospital	Calgary	Alberta	Canada	T3B 6A8
36	Stollery Children'S Hospital	Edmonton	Alberta	Canada	T6G 2B7
37	Bc Children'S Hospital	Vancouver	British Columbia	Canada	V6H 3V4
38	Iwk Health Centre	Halifax	Nova Scotia	Canada	B3K 6R8
39	Children'S Hospital Of Eastern Ontario	Ottawa	Ontario	Canada	K1H 8L1
40	The Hospital For Sick Children	Toronto	Ontario	Canada	M5G 1X8
41	Chu Ste-Justine	Montreal	Quebec	Canada	H3T 1C5
42	Local Institution	Lyon		France	69008
43	Local Institution	Nantes		France	44093
44	Local Institution	Paris Cedex 12		France	75571
45	Local Institution	Paris		France	75012
46	Local Institution	Paris		France	75935
47	Local Institution	Poitiers		France	86000
48	Local Institution	Frankfurt		Germany	60590
49	Local Institution	Hannover		Germany	30625
50	Local Institution	Navrangpura, Ahmedabad	Gujarat	India	380009
51	Local Institution	Bangalore	Karnataka	India	560027
52	Local Institution	Mumbai	Maharashtra	India	400010
53	Local Institution	Pune	Maharashtra	India	411001
54	Local Institution	Madurai	Tamil Nadu	India	625107
55	Local Institution	Vellore	Tamilnadu	India	632004
56	Local Institution	Kolkatta		India	700 016
57	Local Institution	Mumbai		India	400010
58	Local Institution	Trivandrum		India	695011
59	Local Institution	Bologna		Italy	40138
60	Local Institution	Monza (mb)		Italy	20900
61	Local Institution	Roma		Italy	00161
62	Local Institution	Roma		Italy	00165
63	Local Institution	Torino		Italy	10126
64	Local Institution	Seoul		Korea, Republic of	05505
65	Local Institution	Seoul		Korea, Republic of	137-701
66	Local Institution	Df	Distrito Federal	Mexico	06720
67	Local Institution	Mexico D.f.	Distrito Federal	Mexico	06726
68	Local Institution	Mexico, D. F.	Distrito Federal	Mexico	06726
69	Local Institution	Mexico	Distrito Federal	Mexico	04530
70	Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca	Guadalajara	Jalisco	Mexico	44340
71	Local Institution	Monterrey, N.l.	Nuevo Leon	Mexico	64180
72	Local Institution	Monterrey	Nuevo Leon	Mexico	64460
73	Local Institution	Rotterdam		Netherlands	3015 GJ
74	Local Institution	Utrecht		Netherlands	3584 CS
75	Local Institution	Bucharest		Romania	022322
76	Local Institution	Moscow		Russian Federation	115478
77	Local Institution	Moscow		Russian Federation	117198
78	Local Institution	Saint-petersburg		Russian Federation	197022
79	Local Institution	Singapore		Singapore	119228
80	Local Institution	Bloemfontein	FREE State	South Africa	9301
81	Local Institution	Pretoria	Gauteng	South Africa	0001
82	Local Institution	Cape Town	Western CAPE	South Africa	7925
83	Local Institution	Tygerberg	Western CAPE	South Africa	7505
84	Local Institution	Barcelona		Spain	08025
85	Local Institution	Barcelona		Spain	08035
86	Local Institution	Madrid		Spain	28009
87	Local Institution	Madrid		Spain	28046
88	Local Institution	Malaga		Spain	29010
89	Local Institution	Valencia		Spain	46009
90	Local Institution	Valencia		Spain
91	Local Institution	Glasgow	Central	United Kingdom	G3 8SJ
92	Local Institution	Sutton	Surrey	United Kingdom	SM2 5PT
93	Local Institution	Birmingham	West Midlands	United Kingdom	B4 6NH

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00777036

Other Study ID Numbers:

CA180-226
2008-002260-33

First Posted:

Oct 22, 2008

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bristol-Myers Squibb

Leukemia, Pediatric

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Dasatinib

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).
Pre-assignment Detail	A total of 145 participants were enrolled and 130 participants were treated in the study. Reasons for non-treatment include 2 withdrew consent, 1 died, 11 failed to meet study criteria, and 1 other non-specified.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Period Title: On Treatment
STARTED	29	17	84
COMPLETED	14	1	61
NOT COMPLETED	15	16	23
Period Title: On Treatment
STARTED	14	13	23
COMPLETED	9	5	19
NOT COMPLETED	5	8	4

Baseline Characteristics

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Total
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Total of all reporting groups
Overall Participants	29	17	84	130
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.60 (4.774)	12.10 (3.680)	11.95 (4.418)	12.12 (4.388)
Age, Customized (participants) [Number]
< 2 years	1 3.4%	0 0%	2 2.4%	3 2.3%
>= 2 to < 7 years	3 10.3%	2 11.8%	10 11.9%	15 11.5%
>= 7 to < 12 years	6 20.7%	6 35.3%	28 33.3%	40 30.8%
>= 12 to < 18 years	17 58.6%	9 52.9%	44 52.4%	70 53.8%
>= 18 years	2 6.9%	0 0%	0 0%	2 1.5%
Sex: Female, Male (Count of Participants)
Female	16 55.2%	9 52.9%	39 46.4%	64 49.2%
Male	13 44.8%	8 47.1%	45 53.6%	66 50.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.9%	0 0%	5 6%	7 5.4%
Not Hispanic or Latino	4 13.8%	0 0%	20 23.8%	24 18.5%
Unknown or Not Reported	23 79.3%	17 100%	59 70.2%	99 76.2%
Race/Ethnicity, Customized (Count of Participants)
White	20 69%	13 76.5%	56 66.7%	89 68.5%
Black or African American	2 6.9%	0 0%	4 4.8%	6 4.6%
Asian	6 20.7%	3 17.6%	23 27.4%	32 24.6%
American Indian or Alaska Native	0 0%	0 0%	1 1.2%	1 0.8%
Other	1 3.4%	1 5.9%	0 0%	2 1.5%

Outcome Measures

1. Primary Outcome

Title	Major Cytogenetic Response (MCyR) Rate
Description	Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Time Frame	From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
Primary efficacy endpoint pre-specified only for participants treated in Cohort 1

Arm/Group Title	Cohort 1
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Measure Participants	29
Number (95% Confidence Interval) [percentage of participants]	89.7 309.3%

2. Primary Outcome

Title	Complete Hematologic Response (CHR) Rate
Description	Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Time Frame	From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
Primary efficacy endpoint pre-specified only for participants treated in Cohort 2

Arm/Group Title	Cohort 2
Arm/Group Description	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Measure Participants	17
Number (95% Confidence Interval) [percentage of participants]	29.4 101.4%

3. Primary Outcome

Title	Complete Cytogenetic Response (CCyR) Rate
Description	Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Time Frame	From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
Primary efficacy endpoint pre-specified only for participants treated in Cohort 3

Arm/Group Title	Cohort 3
Arm/Group Description	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	84
Number (95% Confidence Interval) [percentage of participants]	94.0 324.1%

4. Secondary Outcome

Title	Major Cytogenetic Response (MCyR) Rate in Cohort 2
Description	Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.
Time Frame	From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
Secondary efficacy endpoint pre-specified only for participants treated in Cohort 2

Arm/Group Title	Cohort 2
Arm/Group Description	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Measure Participants	17
Number (95% Confidence Interval) [percent of participants]	52.9 182.4%

5. Secondary Outcome

Title	Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
Description	Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.
Time Frame	From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3

Arm/Group Title	Cohort 1	Cohort 3
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	84
Number (95% Confidence Interval) [percentage of participants]	93.1 321%	96.4 567.1%

6. Secondary Outcome

Title	Rate of Best Cytogenetic Response
Description	The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on >=20 Metaphases)
Time Frame	From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
Complete (0%)	82.8 285.5%	29.4 172.9%	94.0 111.9%	96.1 73.9%	90.9 NaN
Partial (>0% - 35%)	6.9 23.8%	23.5 138.2%	2.4 2.9%	2.0 1.5%	3.0 NaN
Minor (>35% - 65%)	3.4 11.7%	0 0%	0 0%	0 0%	0 NaN
Minimal (>65% - 95%)	3.4 11.7%	0 0%	1.2 1.4%	2.0 1.5%	0 NaN
No Response (>95% - 100%)	0 0%	5.9 34.7%	0 0%	0 0%	0 NaN
Unable to Determine	3.4 11.7%	41.2 242.4%	2.4 2.9%	0 0%	6.1 NaN

7. Secondary Outcome

Title	Time to Major Cytogenetic Response (MCyR)
Description	Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on >=20 Metaphases)
Time Frame	From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants with MCyR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	26	9	81	50	31
Median (95% Confidence Interval) [months]	3.1	1.6	3.0	3.3	3.0

8. Secondary Outcome

Title	Duration of Major Cytogenetic Response (MCyR)
Description	Duration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)
Time Frame	From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants with MCyR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	26	9	81	50	31
Median (95% Confidence Interval) [months]	NA	11.2	NA	NA	NA

9. Secondary Outcome

Title	Time to Complete Cytogenetic Response (CCyR)
Description	Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on >=20 Metaphases)
Time Frame	From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants with CCyR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	24	5	79	49	30
Median (95% Confidence Interval) [months]	3.9	1.6	5.6	5.7	5.6

10. Secondary Outcome

Title	Duration of Complete Cytogenetic Response (CCyR)
Description	Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)
Time Frame	From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants who achieved CCyR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	24	5	79	49	30
Median (95% Confidence Interval) [months]	NA	NA	NA	NA	NA

11. Secondary Outcome

Title	Progression-Free Survival (PFS) Rate at 2 Years
Description	PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir -Death from any case during treatment
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
Number (95% Confidence Interval) [percentage]	81.7	20.5	95.1	94.0	96.8

12. Secondary Outcome

Title	Time to Complete Hematologic Response (CHR)
Description	Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
Time Frame	From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants with CHR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	27	5	81	51	30
Median (95% Confidence Interval) [months]	0.7	2.5	1.2	1.2	1.0

13. Secondary Outcome

Title	Duration of Complete Hemotologic Response (CHR)
Description	Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.
Time Frame	From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants with CCyR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	27	5	81	51	30
Median (95% Confidence Interval) [months]	NA	NA	NA	NA	NA

14. Secondary Outcome

Title	Disease-Free Survival Rate at 2 Years
Description	Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
All randomized treated participants with response of CCyR or CHR

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	24	5	79	49	30
Number (95% Confidence Interval) [percentage]	86.9	60.0	98.7	97.9	100

15. Secondary Outcome

Title	Overall Survival (OS) Rate at 2 Years
Description	OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
All randomized and treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
Number (95% Confidence Interval) [percentage]	96.4	32.2	100	100	100

16. Secondary Outcome

Title	Major Molecular Response (MMR) Rate
Description	Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.
Time Frame	From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All randomized treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
Number (95% Confidence Interval) [percentage of participants]	62.1 214.1%	29.4 172.9%	79.8 95%	88.2 67.8%	66.7 NaN

17. Secondary Outcome

Title	Complete Molecular Response (CMR) Rate
Description	Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Time Frame	From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
Number (95% Confidence Interval) [percentage]	24.1	17.6	29.8	43.1	9.1

18. Secondary Outcome

Title	Major Cytogenetic Response (MCyR) Rate up to 2 Years
Description	Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
All randomized treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
12 months	89.7 309.3%	58.8 345.9%	96.4 114.8%	98.0 75.4%	93.9 NaN
24 months	89.7 309.3%	58.8 345.9%	96.4 114.8%	98.0 75.4%	93.9 NaN

19. Secondary Outcome

Title	Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Description	Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
All randomized treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
12 months	75.9 261.7%	41.2 242.4%	92.9 110.6%	96.1 73.9%	87.9 NaN
24 months	82.8 285.5%	41.2 242.4%	94.0 111.9%	96.1 73.9%	90.9 NaN

20. Secondary Outcome

Title	Major Molecular Response (MMR) Rate up to 2 Years
Description	Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
All randomized treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
12 months	41.4 142.8%	23.5 138.2%	52.4 62.4%	56.9 43.8%	45.5 NaN
24 months	55.2 190.3%	29.4 172.9%	70.2 83.6%	74.5 57.3%	63.6 NaN

21. Secondary Outcome

Title	Complete Molecular Response (CMR) Rate up to 2 Years
Description	Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
All randomized treated participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 3a	Cohort 3b
Arm/Group Description	Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.	Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Measure Participants	29	17	84	51	33
12 months	6.9	11.8	8.3	9.8	6.1
24 months	17.2	11.8	21.4	29.4	9.1

Adverse Events

	Cohort 3a		Cohort 3b		Cohort 1		Cohort 2: BP-CML Only		Cohort 2: Ph+ ALL Only
Time Frame	From date of first dose of study therapy to date of last dose plus 30 days (assessed up to September 2016, approximately 90 months)
Adverse Event Reporting Description

Arm/Group Title	Cohort 3a		Cohort 3b		Cohort 1		Cohort 2: BP-CML Only		Cohort 2: Ph+ ALL Only
Arm/Group Description	Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.		Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.		Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.		Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.		Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort 3a		Cohort 3b		Cohort 1		Cohort 2: BP-CML Only		Cohort 2: Ph+ ALL Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/51 (37.3%)		9/33 (27.3%)		13/29 (44.8%)		7/8 (87.5%)		6/9 (66.7%)
Blood and lymphatic system disorders
Anaemia	3/51 (5.9%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Febrile neutropenia	2/51 (3.9%)		1/33 (3%)		0/29 (0%)		2/8 (25%)		3/9 (33.3%)
Leukocytosis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		1/9 (11.1%)
Leukopenia	0/51 (0%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Lymphadenopathy	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Neutropenia	0/51 (0%)		1/33 (3%)		2/29 (6.9%)		2/8 (25%)		0/9 (0%)
Cardiac disorders
Left ventricular dysfunction	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Gastrointestinal disorders
Abdominal pain	2/51 (3.9%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Anal ulcer	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Colitis	1/51 (2%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		1/9 (11.1%)
Diarrhoea	0/51 (0%)		3/33 (9.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Enteritis	0/51 (0%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Gastrointestinal haemorrhage	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Haematochezia	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Pancreatitis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Rectal haemorrhage	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Stomatitis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Vomiting	0/51 (0%)		3/33 (9.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
General disorders
Chills	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Disease progression	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Fatigue	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Oedema peripheral	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Pain	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Pyrexia	2/51 (3.9%)		3/33 (9.1%)		2/29 (6.9%)		2/8 (25%)		0/9 (0%)
Hepatobiliary disorders
Hepatic function abnormal	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Immune system disorders
Drug hypersensitivity	0/51 (0%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Infections and infestations
Bacterial sepsis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Cellulitis	0/51 (0%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Device related infection	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Gastroenteritis	1/51 (2%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Gastrointestinal infection	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Infection	1/51 (2%)		0/33 (0%)		2/29 (6.9%)		1/8 (12.5%)		0/9 (0%)
Meningitis aseptic	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Myringitis	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Oral herpes	0/51 (0%)		0/33 (0%)		0/29 (0%)		2/8 (25%)		0/9 (0%)
Otitis externa	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Periorbital cellulitis	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Sepsis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Upper aerodigestive tract infection	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Upper respiratory tract infection	0/51 (0%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Injury, poisoning and procedural complications
Facial bones fracture	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Gun shot wound	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Hand fracture	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Overdose	1/51 (2%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Investigations
Alanine aminotransferase increased	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Aspartate aminotransferase increased	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
White blood cell count decreased	2/51 (3.9%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Dehydration	2/51 (3.9%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Musculoskeletal and connective tissue disorders
Osteonecrosis	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Pain in extremity	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Blast cell proliferation	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Blast crisis in myelogenous leukaemia	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Chronic myeloid leukaemia	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Leukaemia	0/51 (0%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Leukaemia recurrent	0/51 (0%)		2/33 (6.1%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Malignant neoplasm progression	0/51 (0%)		0/33 (0%)		0/29 (0%)		2/8 (25%)		2/9 (22.2%)
Nervous system disorders
Arachnoiditis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Depressed level of consciousness	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Facial nerve disorder	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Headache	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Peripheral motor neuropathy	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Presyncope	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Seizure	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Syncope	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Psychiatric disorders
Confusional state	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Personality change	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Suicidal ideation	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Reproductive system and breast disorders
Genital haemorrhage	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Uterine haemorrhage	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Pulmonary haemorrhage	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Respiratory failure	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	1/51 (2%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Surgical and medical procedures
Bone marrow transplant	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Vascular disorders
Jugular vein thrombosis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 3a		Cohort 3b		Cohort 1		Cohort 2: BP-CML Only		Cohort 2: Ph+ ALL Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	50/51 (98%)		33/33 (100%)		27/29 (93.1%)		7/8 (87.5%)		9/9 (100%)
Blood and lymphatic system disorders
Anaemia	10/51 (19.6%)		5/33 (15.2%)		2/29 (6.9%)		2/8 (25%)		2/9 (22.2%)
Febrile neutropenia	0/51 (0%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Haemoglobinaemia	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Leukopenia	3/51 (5.9%)		2/33 (6.1%)		2/29 (6.9%)		2/8 (25%)		0/9 (0%)
Lymphadenopathy	1/51 (2%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Lymphopenia	1/51 (2%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Neutropenia	17/51 (33.3%)		8/33 (24.2%)		6/29 (20.7%)		4/8 (50%)		3/9 (33.3%)
Pancytopenia	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Thrombocytopenia	13/51 (25.5%)		7/33 (21.2%)		5/29 (17.2%)		4/8 (50%)		4/9 (44.4%)
Ear and labyrinth disorders
Ear pain	7/51 (13.7%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Hypoacusis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Eye disorders
Dry eye	1/51 (2%)		2/33 (6.1%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Eye oedema	1/51 (2%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Eye pain	3/51 (5.9%)		1/33 (3%)		3/29 (10.3%)		0/8 (0%)		2/9 (22.2%)
Periorbital oedema	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Vision blurred	3/51 (5.9%)		1/33 (3%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Gastrointestinal disorders
Abdominal pain	18/51 (35.3%)		7/33 (21.2%)		10/29 (34.5%)		1/8 (12.5%)		2/9 (22.2%)
Abdominal pain upper	12/51 (23.5%)		4/33 (12.1%)		8/29 (27.6%)		0/8 (0%)		0/9 (0%)
Anal fissure	0/51 (0%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Anal ulcer	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Colitis	3/51 (5.9%)		1/33 (3%)		1/29 (3.4%)		1/8 (12.5%)		1/9 (11.1%)
Constipation	9/51 (17.6%)		5/33 (15.2%)		4/29 (13.8%)		2/8 (25%)		0/9 (0%)
Diarrhoea	27/51 (52.9%)		12/33 (36.4%)		17/29 (58.6%)		3/8 (37.5%)		3/9 (33.3%)
Dyspepsia	0/51 (0%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Flatulence	0/51 (0%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Gastritis	6/51 (11.8%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Gingival bleeding	2/51 (3.9%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Mouth ulceration	0/51 (0%)		2/33 (6.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Nausea	20/51 (39.2%)		10/33 (30.3%)		11/29 (37.9%)		3/8 (37.5%)		2/9 (22.2%)
Oral pain	2/51 (3.9%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Stomatitis	2/51 (3.9%)		4/33 (12.1%)		0/29 (0%)		2/8 (25%)		1/9 (11.1%)
Tongue ulceration	0/51 (0%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Toothache	4/51 (7.8%)		1/33 (3%)		3/29 (10.3%)		0/8 (0%)		1/9 (11.1%)
Vomiting	22/51 (43.1%)		11/33 (33.3%)		15/29 (51.7%)		3/8 (37.5%)		3/9 (33.3%)
General disorders
Asthenia	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Chest pain	2/51 (3.9%)		0/33 (0%)		3/29 (10.3%)		0/8 (0%)		0/9 (0%)
Chills	0/51 (0%)		3/33 (9.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Fatigue	10/51 (19.6%)		7/33 (21.2%)		8/29 (27.6%)		1/8 (12.5%)		2/9 (22.2%)
Influenza like illness	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Malaise	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Mass	1/51 (2%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Mucosal inflammation	0/51 (0%)		2/33 (6.1%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Non-cardiac chest pain	3/51 (5.9%)		3/33 (9.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Oedema peripheral	2/51 (3.9%)		1/33 (3%)		3/29 (10.3%)		1/8 (12.5%)		0/9 (0%)
Pain	6/51 (11.8%)		5/33 (15.2%)		3/29 (10.3%)		1/8 (12.5%)		1/9 (11.1%)
Peripheral swelling	0/51 (0%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Pyrexia	23/51 (45.1%)		10/33 (30.3%)		14/29 (48.3%)		1/8 (12.5%)		5/9 (55.6%)
Immune system disorders
Drug hypersensitivity	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Hypersensitivity	0/51 (0%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Infections and infestations
Abscess	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		1/9 (11.1%)
Bronchitis	0/51 (0%)		1/33 (3%)		3/29 (10.3%)		0/8 (0%)		0/9 (0%)
Cellulitis	3/51 (5.9%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Conjunctivitis	2/51 (3.9%)		2/33 (6.1%)		3/29 (10.3%)		0/8 (0%)		0/9 (0%)
Ear infection	5/51 (9.8%)		3/33 (9.1%)		1/29 (3.4%)		0/8 (0%)		1/9 (11.1%)
Febrile infection	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Folliculitis	2/51 (3.9%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Gastroenteritis	7/51 (13.7%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		1/9 (11.1%)
Gastroenteritis viral	0/51 (0%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Gingivitis	1/51 (2%)		0/33 (0%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Herpes virus infection	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hordeolum	0/51 (0%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		1/9 (11.1%)
Influenza	6/51 (11.8%)		1/33 (3%)		3/29 (10.3%)		0/8 (0%)		0/9 (0%)
Localised infection	1/51 (2%)		2/33 (6.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Lower respiratory tract infection	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Nasopharyngitis	10/51 (19.6%)		4/33 (12.1%)		7/29 (24.1%)		0/8 (0%)		0/9 (0%)
Oral herpes	4/51 (7.8%)		1/33 (3%)		0/29 (0%)		2/8 (25%)		0/9 (0%)
Otitis media	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Pharyngitis	6/51 (11.8%)		1/33 (3%)		2/29 (6.9%)		2/8 (25%)		2/9 (22.2%)
Rhinitis	7/51 (13.7%)		4/33 (12.1%)		3/29 (10.3%)		0/8 (0%)		1/9 (11.1%)
Sinusitis	3/51 (5.9%)		2/33 (6.1%)		4/29 (13.8%)		0/8 (0%)		1/9 (11.1%)
Tonsillitis	3/51 (5.9%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Tooth infection	3/51 (5.9%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Upper respiratory tract infection	16/51 (31.4%)		11/33 (33.3%)		9/29 (31%)		1/8 (12.5%)		1/9 (11.1%)
Viral infection	3/51 (5.9%)		0/33 (0%)		3/29 (10.3%)		0/8 (0%)		1/9 (11.1%)
Injury, poisoning and procedural complications
Arthropod bite	0/51 (0%)		2/33 (6.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Contusion	3/51 (5.9%)		4/33 (12.1%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Foot fracture	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Procedural pain	2/51 (3.9%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Sunburn	1/51 (2%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Investigations
Alanine aminotransferase increased	3/51 (5.9%)		4/33 (12.1%)		4/29 (13.8%)		3/8 (37.5%)		1/9 (11.1%)
Aspartate aminotransferase increased	3/51 (5.9%)		3/33 (9.1%)		3/29 (10.3%)		2/8 (25%)		0/9 (0%)
Blood creatinine increased	0/51 (0%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Blood lactate dehydrogenase increased	2/51 (3.9%)		4/33 (12.1%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Blood phosphorus decreased	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Blood urea increased	0/51 (0%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Gamma-glutamyltransferase increased	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Haemoglobin decreased	0/51 (0%)		5/33 (15.2%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Neutrophil count decreased	1/51 (2%)		5/33 (15.2%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Platelet count decreased	2/51 (3.9%)		11/33 (33.3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Weight decreased	3/51 (5.9%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Weight increased	3/51 (5.9%)		3/33 (9.1%)		2/29 (6.9%)		1/8 (12.5%)		0/9 (0%)
Metabolism and nutrition disorders
Decreased appetite	4/51 (7.8%)		1/33 (3%)		2/29 (6.9%)		1/8 (12.5%)		0/9 (0%)
Fluid retention	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Hypercalcaemia	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Hyperkalaemia	0/51 (0%)		3/33 (9.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Hypermagnesaemia	1/51 (2%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hypernatraemia	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hyperphosphataemia	0/51 (0%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hyperuricaemia	0/51 (0%)		4/33 (12.1%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hypoalbuminaemia	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hypocalcaemia	2/51 (3.9%)		3/33 (9.1%)		2/29 (6.9%)		1/8 (12.5%)		0/9 (0%)
Hypokalaemia	2/51 (3.9%)		1/33 (3%)		0/29 (0%)		2/8 (25%)		1/9 (11.1%)
Hypomagnesaemia	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hyponatraemia	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Hypophosphataemia	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/51 (21.6%)		6/33 (18.2%)		6/29 (20.7%)		1/8 (12.5%)		1/9 (11.1%)
Back pain	7/51 (13.7%)		6/33 (18.2%)		4/29 (13.8%)		1/8 (12.5%)		0/9 (0%)
Bone pain	5/51 (9.8%)		0/33 (0%)		1/29 (3.4%)		1/8 (12.5%)		3/9 (33.3%)
Coccydynia	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Groin pain	3/51 (5.9%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Muscle spasms	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		1/9 (11.1%)
Musculoskeletal chest pain	1/51 (2%)		4/33 (12.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Musculoskeletal pain	5/51 (9.8%)		7/33 (21.2%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Musculoskeletal stiffness	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Myalgia	3/51 (5.9%)		6/33 (18.2%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Neck pain	2/51 (3.9%)		2/33 (6.1%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Pain in extremity	11/51 (21.6%)		14/33 (42.4%)		15/29 (51.7%)		2/8 (25%)		0/9 (0%)
Pain in jaw	0/51 (0%)		1/33 (3%)		3/29 (10.3%)		0/8 (0%)		0/9 (0%)
Tendonitis	0/51 (0%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	3/51 (5.9%)		3/33 (9.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Nervous system disorders
Arachnoiditis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Brain oedema	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Dizziness	12/51 (23.5%)		3/33 (9.1%)		2/29 (6.9%)		1/8 (12.5%)		0/9 (0%)
Dysgeusia	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Facial paralysis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Headache	24/51 (47.1%)		15/33 (45.5%)		17/29 (58.6%)		3/8 (37.5%)		5/9 (55.6%)
Neuropathy peripheral	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Paraesthesia	0/51 (0%)		1/33 (3%)		5/29 (17.2%)		0/8 (0%)		0/9 (0%)
Somnolence	0/51 (0%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Psychiatric disorders
Anxiety	2/51 (3.9%)		3/33 (9.1%)		2/29 (6.9%)		1/8 (12.5%)		1/9 (11.1%)
Depression	4/51 (7.8%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Insomnia	3/51 (5.9%)		2/33 (6.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Renal and urinary disorders
Dysuria	4/51 (7.8%)		1/33 (3%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Urinary incontinence	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Reproductive system and breast disorders
Breast mass	1/51 (2%)		0/33 (0%)		1/29 (3.4%)		1/8 (12.5%)		0/9 (0%)
Dysmenorrhoea	4/51 (7.8%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Menstruation irregular	0/51 (0%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Vaginal discharge	3/51 (5.9%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Vaginal haemorrhage	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Respiratory, thoracic and mediastinal disorders
Cough	16/51 (31.4%)		9/33 (27.3%)		13/29 (44.8%)		1/8 (12.5%)		4/9 (44.4%)
Dyspnoea	4/51 (7.8%)		2/33 (6.1%)		3/29 (10.3%)		1/8 (12.5%)		0/9 (0%)
Epistaxis	5/51 (9.8%)		4/33 (12.1%)		3/29 (10.3%)		0/8 (0%)		1/9 (11.1%)
Nasal congestion	3/51 (5.9%)		2/33 (6.1%)		3/29 (10.3%)		0/8 (0%)		0/9 (0%)
Oropharyngeal pain	10/51 (19.6%)		11/33 (33.3%)		6/29 (20.7%)		1/8 (12.5%)		0/9 (0%)
Pharyngeal erythema	3/51 (5.9%)		5/33 (15.2%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Productive cough	1/51 (2%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Respiratory failure	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Respiratory tract congestion	0/51 (0%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Rhinalgia	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Rhinitis allergic	3/51 (5.9%)		3/33 (9.1%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Rhinorrhoea	11/51 (21.6%)		4/33 (12.1%)		3/29 (10.3%)		1/8 (12.5%)		1/9 (11.1%)
Wheezing	3/51 (5.9%)		2/33 (6.1%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Skin and subcutaneous tissue disorders
Acne	1/51 (2%)		7/33 (21.2%)		3/29 (10.3%)		0/8 (0%)		1/9 (11.1%)
Alopecia	5/51 (9.8%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Dermatitis acneiform	2/51 (3.9%)		2/33 (6.1%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Dry skin	2/51 (3.9%)		0/33 (0%)		4/29 (13.8%)		0/8 (0%)		1/9 (11.1%)
Eczema	1/51 (2%)		1/33 (3%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Erythema	4/51 (7.8%)		2/33 (6.1%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Papule	1/51 (2%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Petechiae	1/51 (2%)		1/33 (3%)		1/29 (3.4%)		0/8 (0%)		1/9 (11.1%)
Pruritus	7/51 (13.7%)		4/33 (12.1%)		5/29 (17.2%)		0/8 (0%)		0/9 (0%)
Rash	14/51 (27.5%)		11/33 (33.3%)		8/29 (27.6%)		1/8 (12.5%)		1/9 (11.1%)
Rash erythematous	3/51 (5.9%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		0/9 (0%)
Rash maculo-papular	0/51 (0%)		3/33 (9.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Rash papular	3/51 (5.9%)		1/33 (3%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Skin exfoliation	0/51 (0%)		0/33 (0%)		1/29 (3.4%)		0/8 (0%)		1/9 (11.1%)
Skin hypopigmentation	1/51 (2%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		1/9 (11.1%)
Skin induration	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Urticaria	3/51 (5.9%)		3/33 (9.1%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Xeroderma	0/51 (0%)		0/33 (0%)		2/29 (6.9%)		0/8 (0%)		0/9 (0%)
Vascular disorders
Haematoma	2/51 (3.9%)		3/33 (9.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Hot flush	0/51 (0%)		0/33 (0%)		0/29 (0%)		0/8 (0%)		1/9 (11.1%)
Hypertension	5/51 (9.8%)		4/33 (12.1%)		1/29 (3.4%)		0/8 (0%)		0/9 (0%)
Phlebitis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)
Thrombophlebitis	0/51 (0%)		0/33 (0%)		0/29 (0%)		1/8 (12.5%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Bristol-Myers Squibb Study Director
Organization	Bristol-Myers Squibb
Phone
Email	Clinical.Trials@bms.com

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00777036

Other Study ID Numbers:

CA180-226
2008-002260-33

First Posted:

Oct 22, 2008

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Study Details

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Additional Information:

Publications

Study Results

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Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

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