A Phase II Study of Dasatinib in Children and Adolescents... | NCT00777036 | Trialant
NCT00777036
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Aug 29, 2025Actual
Enrollment
133Actual
Phase
Phase 2
Conditions
Leukemia
Interventions
Dasatinib
Countries
United States
Argentina
Australia
Brazil
Canada
France
Germany
India
Italy
Mexico
Netherlands
Romania
Russia
Singapore
South Africa
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00777036
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA180-226
Secondary IDs
ID
Type
Description
Link
2008-002260-33
EudraCT Number
Brief Title
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
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
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 20, 2009Actual
Primary Completion Date
Sep 1, 2016Actual
Completion Date
Jan 27, 2025Actual
First Submitted Date
Oct 21, 2008
First Submission Date that Met QC Criteria
Oct 21, 2008
First Posted Date
Oct 22, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 6, 2017
Results First Submitted that Met QC Criteria
Dec 6, 2017
Results First Posted Date
Jan 5, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 23, 2017
Certification/Extension First Submitted that Passed QC Review
Aug 23, 2017
Certification/Extension First Posted Date
Aug 24, 2017Actual
Last Update Submitted Date
Aug 12, 2025
Last Update Posted Date
Aug 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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
Detailed Description
Not provided
Conditions Module
Conditions
Leukemia
Keywords
Leukemia, Pediatric
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
133Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Imatinib-resistant/intolerant CP-CML
Experimental
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
Cohort 2: Ph+ALL or AP- or BP-CML
Experimental
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
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
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.
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
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.
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
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.
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary Outcomes
Measure
Description
Time Frame
Major Cytogenetic Response (MCyR) Rate in Cohort 2
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.
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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)
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
Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.
The PK sub-study analysis is not part of the pre-specified primary and secondary outcome measures.
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).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1
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.
FG001
Cohort 2
Periods
Title
Milestones
Reasons Not Completed
On Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Sprycel (BMS-354825)
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
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.
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Rate of Best Cytogenetic Response
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)
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Time to Major Cytogenetic Response (MCyR)
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)
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
Duration of Major Cytogenetic Response (MCyR)
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)
From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
Time to Complete Cytogenetic Response (CCyR)
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)
From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
Duration of Complete Cytogenetic Response (CCyR)
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)
From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
Progression-Free Survival (PFS)
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. Based on Kaplan-Meier methodology. 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.
174 Months
Time to Complete Hematologic Response (CHR)
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.
From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
Duration of Complete Hemotologic Response (CHR)
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.
From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
Disease-Free Survival
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. Based on Kaplan-Meier methodology. (CML: Chronic Myeloid Leukemia).
168 Months
Overall Survival (OS)
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. Based on Kaplan-Meier methodology using graphs.
174 Months
Major Molecular Response (MMR) Rate
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.
From date of first treatment to date of MMR (assessed up to Jan 2025, approximately 15 years and 10 months)
Complete Molecular Response (CMR) Rate
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.
From date of first treatment to date of CMR (assessed up to Jan 2025, approximately 15 years and 10 months)
Major Cytogenetic Response (MCyR) Rate up to 2 Years
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.
24 months
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
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.
24 months
Major Molecular Response (MMR) Rate up to 7.5 Years
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.
90 months
Complete Molecular Response (CMR) Rate up to 7.5 Years
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.
90 months
Phoenix
Arizona
85016
United States
Phoenix Children'S Hospital
Phoenix
Arizona
85016
United States
Jonathan Jaques Children'S Cancer Center
Long Beach
California
90801-1428
United States
Jonathan Jaques Children'S Cancer Center
Long Beach
California
90806
United States
Local Institution - 0001
Long Beach
California
90806
United States
Children'S Hospital Of Orange County
Orange
California
92868
United States
Local Institution - 0024
Orange
California
92868
United States
Children'S Hospital
Aurora
Colorado
80045
United States
Local Institution - 0004
Aurora
Colorado
80045
United States
Children's Healthcare Of Atlanta - Egleston
Atlanta
Georgia
30322
United States
Local Institution - 047
Atlanta
Georgia
30322
United States
Children's Hospital of Chicago
Chicago
Illinois
60611
United States
Local Institution - 0072
Chicago
Illinois
60611
United States
Local Institution
Chicago
Illinois
60611
United States
Dana Faber Cancer Institute
Boston
Massachusetts
02215
United States
Dana Farber Cancer Institute.
Boston
Massachusetts
02215
United States
Local Institution - 0040
Boston
Massachusetts
02215
United States
Stephen D. Hassenfeld Children'S Center
New York
New York
10016
United States
Local Institution - 0061
New York
New York
10021
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Memorial Sloan Kettering Nassau
New York
New York
10065
United States
Oregon Health & Sci Univ
Portland
Oregon
97239-3098
United States
Local Institution - 0002
Portland
Oregon
97239
United States
Oregon Health & Sci Univ
Portland
Oregon
97239
United States
Children'S Hospital Of Philadelphia
Philadelphia
Pennsylvania
19104-4318
United States
Local Institution - 0014
Philadelphia
Pennsylvania
19104-4318
United States
Children'S Hospital Of Pittsburgh
Pittsburgh
Pennsylvania
15224
United States
Local Institution - 0003
Pittsburgh
Pennsylvania
15224
United States
Local Institution - 0035
Houston
Texas
77030-4009
United States
MD Anderson Cancer Center
Houston
Texas
77030-4009
United States
Local Institution - 0048
Houston
Texas
77030
United States
Texas Children'S Cancer Center
Houston
Texas
77030
United States
Local Institution - 0028
Seattle
Washington
98105
United States
Seattle Children'S
Seattle
Washington
98105
United States
Local Institution - 0043
Bunos Aires
Buenos Aires
1425
Argentina
Local Institution
Bunos Aires
Buenos Aires
1425
Argentina
Hospital Nacional Profesor Alejandro Posadas
El Palomar
Buenos Aires
1684
Argentina
Local Institution - 0049
El Palomar
Buenos Aires
1684
Argentina
Local Institution - 0042
Córdoba
5016
Argentina
Local Institution
Córdoba
5016
Argentina
Local Institution - 065
Randwick
New South Wales
2031
Australia
Local Institution
Randwick
New South Wales
2031
Australia
Local Institution - 069
Westmead
New South Wales
2145
Australia
Local Institution
Westmead
New South Wales
2145
Australia
Local Institution - 0064
Sth Brisbane
Queensland
4101
Australia
Local Institution
Sth Brisbane
Queensland
4101
Australia
Local Institution - 067
North Adelaide
South Australia
5006
Australia
Local Institution
North Adelaide
South Australia
5006
Australia
Local Institution - 0066
Parkville
Victoria
3052
Australia
Local Institution
Parkville
Victoria
3052
Australia
Local Institution - 0021
Curitiba
Paraná
80060-900
Brazil
Local Institution
Curitiba
Paraná
80060-900
Brazil
Local Institution - 0022
Porto Alegre
Rio Grande do Sul
90035-003
Brazil
Local Institution
Porto Alegre
Rio Grande do Sul
90035-003
Brazil
Local Institution - 0019
São Paulo
São Paulo
04520-013
Brazil
Local Institution - 0020
Campinas
13083-970
Brazil
Local Institution
Campinas
13083-970
Brazil
Local Institution - 0039
São Paulo
01401-000
Brazil
Local Institution
São Paulo
01401-000
Brazil
Local Institution
São Paulo
04023-062
Brazil
Alberta Children'S Hospital
Calgary
Alberta
T3B 6A8
Canada
Local Institution - 0079
Calgary
Alberta
T3B 6A8
Canada
Local Institution - 0078
Edmonton
Alberta
T6G 2B7
Canada
Stollery Children'S Hospital
Edmonton
Alberta
T6G 2B7
Canada
Bc Children'S Hospital
Vancouver
British Columbia
V6H 3V4
Canada
Local Institution - 077
Vancouver
British Columbia
V6H 3V4
Canada
Iwk Health Centre
Halifax
Nova Scotia
B3K 6R8
Canada
Local Institution - 073
Halifax
Nova Scotia
B3K 6R8
Canada
Children'S Hospital Of Eastern Ontario
Ottawa
Ontario
K1H 8L1
Canada
Local Institution - 086
Ottawa
Ontario
K1H 8L1
Canada
Local Institution - 076
Toronto
Ontario
M5G 1X8
Canada
The Hospital For Sick Children
Toronto
Ontario
M5G 1X8
Canada
Chu Ste-Justine
Montreal
Quebec
H3T 1C5
Canada
Local Institution - 080
Montreal
Quebec
H3T 1C5
Canada
Local Institution - 0030
Lyon
69008
France
Local Institution
Lyon
69008
France
Local Institution - 0032
Nantes
44093
France
Local Institution
Nantes
44093
France
Local Institution - 0037
Paris
75012
France
Local Institution
Paris
75012
France
Local Institution
Paris
75571
France
Local Institution - 0029
Paris
75935
France
Local Institution
Paris
75935
France
Local Institution - 036
Poitiers
86000
France
Local Institution
Poitiers
86000
France
Local Institution - 075
Frankfurt
60590
Germany
Local Institution
Frankfurt
60590
Germany
Local Institution - 0074
Hanover
30625
Germany
Local Institution
Hanover
30625
Germany
Local Institution - 0089
Navrangpura, Ahmedabad
Gujarat
380009
India
Local Institution
Navrangpura, Ahmedabad
Gujarat
380009
India
Local Institution
Bangalore
Karnataka
560027
India
Local Institution
Mumbai
Maharashtra
400010
India
Local Institution - 0094
Pune
Maharashtra
411001
India
Local Institution
Pune
Maharashtra
411001
India
Local Institution - 0093
Madurai
Tamil Nadu
625107
India
Local Institution
Madurai
Tamil Nadu
625107
India
Local Institution
Vellore
Tamil Nadu
632004
India
Local Institution - 0088
Bangalore
560027
India
Local Institution - 0082
Kolkata
700 016
India
Local Institution
Kolkata
700 016
India
Local Institution - 0085
Mumbai
400010
India
Local Institution
Mumbai
400010
India
Local Institution - 0084
Trivandrum
695011
India
Local Institution
Trivandrum
695011
India
Local Institution - 038
Bologna
40138
Italy
Local Institution
Bologna
40138
Italy
Local Institution - 006
Monza
20900
Italy
Local Institution
Monza (MB)
20900
Italy
Local Institution - 070
Roma
00161
Italy
Local Institution
Roma
00161
Italy
Local Institution - 0059
Roma
00165
Italy
Local Institution
Roma
00165
Italy
Local Institution - 015
Torino
10126
Italy
Local Institution
Torino
10126
Italy
Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
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.
FG002
Cohort 3
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.
FG003
PK Sub-Study
Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
FG00029 subjects
FG00117 subjects
FG00284 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00029 subjects
FG00117 subjects
FG00284 subjects
FG0030 subjects
Type
Comment
Reasons
Reached 18 years of age and transitioned to commercial drug
FG00013 subjects
FG0017 subjects
FG00242 subjects
FG0030 subjects
Administrative Reason By Sponsor
FG0001 subjects
FG0010 subjects
FG0029 subjects
FG0030 subjects
Failure to Meet Study Criteria
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
Pregnancy
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Non-compliance with Study Drug
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Maximum Clinical Benefit
FG0002 subjects
FG0010 subjects
FG0025 subjects
FG0030 subjects
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
Participant Request to Discontinue Study Treatment
FG0004 subjects
FG0010 subjects
FG0026 subjects
FG0030 subjects
Death
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Study Drug Toxicity
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
Progressive Disease
FG0006 subjects
FG0014 subjects
FG0027 subjects
FG0030 subjects
Not Reported
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Site Closed
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
PK Sub-Study
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects4 Participants Joined PK Sub-study from Cohort 3
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjectsAll 7 participants Completed. 4 participants who joined from cohort 3 re-joined Cohort 3 after PK Sub-study completed.
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Follow-Up
Type
Comment
Milestone Data
STARTED
FG00021 subjectsNot all participants who discontinued treatment entered the follow-up period
FG00112 subjectsNot all participants who discontinued treatment entered the follow-up period
FG00247 subjectsNot all participants who discontinued treatment entered the follow-up period
FG0030 subjects
COMPLETED
FG00012 subjects
FG0013 subjects
FG00225 subjects
FG0030 subjects
NOT COMPLETED
FG0009 subjects
FG0019 subjects
FG00222 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
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.
BG001
Cohort 2
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.
BG002
Cohort 3
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.
BG003
PK Sub-Study
Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00029
BG00117
BG00284
BG0033
BG004133
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00012.60± 4.774
BG00112.10± 3.680
BG00211.95± 4.418
BG003
Age, Customized
Number
participants
Title
Denominators
Categories
< 2 years
Title
Measurements
BG0001
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00020
BG00113
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Major Cytogenetic Response (MCyR) Rate
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.
Primary efficacy endpoint pre-specified only for participants treated in Cohort 1
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG00089.7(72.6 to 97.8)
Primary
Complete Hematologic Response (CHR) Rate
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.
Primary efficacy endpoint pre-specified only for participants treated in Cohort 2
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 2
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.
Units
Counts
Participants
OG000
Primary
Complete Cytogenetic Response (CCyR) Rate
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.
Primary efficacy endpoint pre-specified only for participants treated in Cohort 3
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 3
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.
Units
Counts
Participants
OG000
Secondary
Major Cytogenetic Response (MCyR) Rate in Cohort 2
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.
Secondary efficacy endpoint pre-specified only for participants treated in Cohort 2
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 2
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.
Units
Counts
Participants
OG000
Secondary
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
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.
Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 3
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.
Units
Counts
Participants
Secondary
Rate of Best Cytogenetic Response
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)
All treated participants
Posted
Number
percentage of participants
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Cohort 3a
Secondary
Time to Major Cytogenetic Response (MCyR)
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)
All treated participants with MCyR
Posted
Median
95% Confidence Interval
months
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Secondary
Duration of Major Cytogenetic Response (MCyR)
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)
All treated participants with MCyR
Posted
Median
95% Confidence Interval
months
From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
Secondary
Time to Complete Cytogenetic Response (CCyR)
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)
All treated participants with CCyR
Posted
Median
95% Confidence Interval
months
From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Secondary
Duration of Complete Cytogenetic Response (CCyR)
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)
All treated participants who achieved CCyR
Posted
Median
95% Confidence Interval
months
From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
Secondary
Progression-Free Survival (PFS)
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. Based on Kaplan-Meier methodology. 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.
All treated participants
Posted
Median
95% Confidence Interval
Months
174 Months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
Secondary
Time to Complete Hematologic Response (CHR)
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.
All treated participants with CHR
Posted
Median
95% Confidence Interval
months
From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Secondary
Duration of Complete Hemotologic Response (CHR)
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.
All treated participants with CCyR
Posted
Median
95% Confidence Interval
months
From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
Secondary
Disease-Free Survival
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. Based on Kaplan-Meier methodology. (CML: Chronic Myeloid Leukemia).
All treated participants with response of CCyR or CHR
Posted
Median
95% Confidence Interval
Months
168 Months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
Secondary
Overall Survival (OS)
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. Based on Kaplan-Meier methodology using graphs.
All treated participants
Posted
Median
95% Confidence Interval
Months
174 Months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
Secondary
Major Molecular Response (MMR) Rate
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.
All treated participants
Posted
Number
95% Confidence Interval
percentage of participants
From date of first treatment to date of MMR (assessed up to Jan 2025, approximately 15 years and 10 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
Secondary
Complete Molecular Response (CMR) Rate
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.
All treated participants
Posted
Number
95% Confidence Interval
percentage of participants
From date of first treatment to date of CMR (assessed up to Jan 2025, approximately 15 years and 10 months)
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
Secondary
Major Cytogenetic Response (MCyR) Rate up to 2 Years
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.
All treated participants
Posted
Number
95% Confidence Interval
percentage of participants
24 months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Secondary
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
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.
All treated participants
Posted
Number
95% Confidence Interval
percentage of participants
24 months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Secondary
Major Molecular Response (MMR) Rate up to 7.5 Years
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.
All treated participants
Posted
Number
95% Confidence Interval
percentage of participants
90 months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
Secondary
Complete Molecular Response (CMR) Rate up to 7.5 Years
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.
All treated participants
Posted
Number
95% Confidence Interval
percentage of participants
90 months
ID
Title
Description
OG000
Cohort 1
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.
OG001
Cohort 2
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.
OG002
Cohort 3
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.
OG003
Time Frame
Participants were assessed for All-Cause Mortality, Serious adverse events (SAEs) and Other adverse events (AEs) in all treated participants (up to approximately 14 years 6 months). The participants who crossed over from Cohort 3 to PK Sub-study are accounted for in both arms. PK Sub-study only for the duration of the PK Sub-study.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1
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.
1
29
16
29
27
29
EG001
Cohort 2: BP-CML Only
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.
4
8
7
8
7
8
EG002
Cohort 2: Ph + ALL Only
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.
7
9
6
9
9
9
EG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
0
51
21
51
50
51
EG004
Cohort 3b
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.
0
33
12
33
33
33
EG005
PK Sub-Study
Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
0
7
0
7
0
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG0033 affected51 at risk
EG0041 affected33 at risk
EG0050 affected7 at risk
Febrile neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected8 at risk
EG0023 affected9 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Anal ulcer
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Enteritis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Haematochezia
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pancreatitis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Chills
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Oedema peripheral
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pain
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Drug hypersensitivity
Immune system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Adenovirus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
COVID-19
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Cellulitis
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Device related infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Enterococcal sepsis
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Enterocolitis infectious
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Infection
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Large intestine infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Meningitis aseptic
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Myringitis
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Oral herpes
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Otitis externa
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Periorbital cellulitis
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Sepsis
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Skin infection
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Upper aerodigestive tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Viral pericarditis
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Overdose
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Blood creatine phosphokinase increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Acute lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Blast cell crisis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Chronic myeloid leukaemia transformation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected8 at risk
EG0022 affected9 at risk
EG003
Arachnoiditis
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Depressed level of consciousness
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Facial nerve disorder
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Presyncope
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Seizure
Nervous system disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Syncope
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Confusional state
Psychiatric disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Personality change
Psychiatric disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Suicidal ideation
Psychiatric disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Ischaemic nephropathy
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Jugular vein thrombosis
Vascular disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected8 at risk
EG0022 affected9 at risk
EG00311 affected51 at risk
EG0047 affected33 at risk
EG0050 affected7 at risk
Febrile neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Haemoglobinaemia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0006 affected29 at risk
EG0014 affected8 at risk
EG0023 affected9 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0005 affected29 at risk
EG0014 affected8 at risk
EG0024 affected9 at risk
EG003
Palpitations
Cardiac disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Sinus bradycardia
Cardiac disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Ear pain
Ear and labyrinth disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Dry eye
Eye disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Eye oedema
Eye disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Eye pain
Eye disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0022 affected9 at risk
EG003
Periorbital oedema
Eye disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Vision blurred
Eye disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.1
Systematic Assessment
EG00010 affected29 at risk
EG0011 affected8 at risk
EG0022 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.1
Systematic Assessment
EG0007 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Anal fissure
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Anal ulcer
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
27.1
Systematic Assessment
EG0004 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Dental caries
Gastrointestinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.1
Systematic Assessment
EG00017 affected29 at risk
EG0013 affected8 at risk
EG0023 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastritis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
27.1
Systematic Assessment
EG00011 affected29 at risk
EG0013 affected8 at risk
EG0022 affected9 at risk
EG003
Oral pain
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected8 at risk
EG0021 affected9 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Toothache
Gastrointestinal disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
27.1
Systematic Assessment
EG00016 affected29 at risk
EG0013 affected8 at risk
EG0023 affected9 at risk
EG003
Asthenia
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Chest discomfort
General disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Chest pain
General disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Chills
General disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Face oedema
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
27.1
Systematic Assessment
EG0008 affected29 at risk
EG0011 affected8 at risk
EG0022 affected9 at risk
EG003
Influenza like illness
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Malaise
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Mass
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Mucosal inflammation
General disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Oedema peripheral
General disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Pain
General disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Peripheral swelling
General disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
27.1
Systematic Assessment
EG00015 affected29 at risk
EG0011 affected8 at risk
EG0025 affected9 at risk
EG003
Swelling face
General disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Drug hypersensitivity
Immune system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Abscess
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Bronchitis
Infections and infestations
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
COVID-19
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Cellulitis
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
27.1
Systematic Assessment
EG0004 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Ear infection
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Febrile infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Folliculitis
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Gastroenteritis viral
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Gingivitis
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Herpes virus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hordeolum
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Influenza
Infections and infestations
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Localised infection
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Lower respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Molluscum contagiosum
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
27.1
Systematic Assessment
EG0008 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Oral herpes
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Otitis media
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Pharyngitis
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected8 at risk
EG0022 affected9 at risk
EG003
Pneumonia
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Rhinitis
Infections and infestations
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Sinusitis
Infections and infestations
27.1
Systematic Assessment
EG0004 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Skin infection
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Tonsillitis
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Tooth infection
Infections and infestations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG00010 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Viral infection
Infections and infestations
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
27.1
Systematic Assessment
EG0004 affected29 at risk
EG0013 affected8 at risk
EG0021 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Blood creatinine increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Blood phosphorus decreased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Blood urea increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Haemoglobin decreased
Investigations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Neutrophil count decreased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Platelet count decreased
Investigations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Weight decreased
Investigations
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Weight increased
Investigations
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hyperalbuminaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected8 at risk
EG0021 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0006 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0005 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0023 affected9 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0004 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG00015 affected29 at risk
EG0012 affected8 at risk
EG0020 affected9 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Arachnoiditis
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Brain oedema
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Facial paralysis
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
27.1
Systematic Assessment
EG00017 affected29 at risk
EG0013 affected8 at risk
EG0025 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
27.1
Systematic Assessment
EG0005 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Somnolence
Nervous system disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Depression
Psychiatric disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Insomnia
Psychiatric disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Urinary incontinence
Renal and urinary disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Breast mass
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG00015 affected29 at risk
EG0011 affected8 at risk
EG0024 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0006 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0004 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0005 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0005 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0009 affected29 at risk
EG0011 affected8 at risk
EG0021 affected9 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Haematoma
Vascular disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hot flush
Vascular disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0021 affected9 at risk
EG003
Hypertension
Vascular disorders
27.1
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Hypotension
Vascular disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Phlebitis
Vascular disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Thrombophlebitis
Vascular disorders
27.1
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected8 at risk
EG0020 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Clinical.Trials@bms.com
ID
Term
D007938
Leukemia
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069439
Dasatinib
Ancestor Terms
ID
Term
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011743
Pyrimidines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
Death
FG0001 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Reason Not Specified
FG0004 subjects
FG0010 subjects
FG00213 subjects
FG0030 subjects
Missing - Administrative Reasons in Russia
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
13.33
± 1.154
BG00412.05± 4.255
2
BG0030
BG0043
>= 2 to < 7 years
Title
Measurements
BG0003
BG0012
BG00210
BG0030
BG00415
>= 7 to < 12 years
Title
Measurements
BG0006
BG0016
BG00228
BG0030
BG00440
>= 12 to < 18 years
Title
Measurements
BG00017
BG0019
BG00244
BG0033
BG00473
>= 18 years
Title
Measurements
BG0002
BG0010
BG0020
BG0030
BG0042
39
BG0032
BG00466
Male
BG00013
BG0018
BG00245
BG0031
BG00467
5
BG0030
BG0047
Not Hispanic or Latino
BG0004
BG0010
BG00220
BG0031
BG00425
Unknown or Not Reported
BG00023
BG00117
BG00259
BG0032
BG004101
56
BG0032
BG00491
Black or African American
Title
Measurements
BG0002
BG0010
BG0024
BG0030
BG0046
Asian
Title
Measurements
BG0006
BG0013
BG00223
BG0030
BG00432
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
Other
Title
Measurements
BG0001
BG0011
BG0020
BG0031
BG0043
17
Title
Denominators
Categories
Title
Measurements
OG00029.4(10.3 to 56.0)
84
Title
Denominators
Categories
Title
Measurements
OG00094.0(86.7 to 98.0)
17
Title
Denominators
Categories
Title
Measurements
OG00052.9(27.8 to 77.0)
OG00029
OG00184
Title
Denominators
Categories
Title
Measurements
OG00093.1(77.2 to 99.2)
OG00196.4(89.9 to 99.3)
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
Complete (0%)
Title
Measurements
OG00082.8
OG00129.4
OG00294.0
OG00396.1
OG00490.9
Partial (>0% - 35%)
Title
Measurements
OG0006.9
OG00123.5
OG0022.4
OG003
Minor (>35% - 65%)
Title
Measurements
OG0003.4
OG0010
OG0020
OG003
Minimal (>65% - 95%)
Title
Measurements
OG0003.4
OG0010
OG0021.2
OG003
No Response (>95% - 100%)
Title
Measurements
OG0000
OG0015.9
OG0020
OG003
Unable to Determine
Title
Measurements
OG0003.4
OG00141.2
OG0022.4
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00026
OG0019
OG00281
OG00350
OG00431
Title
Denominators
Categories
Title
Measurements
OG0003.1(2.8 to 4.1)
OG0011.6(0.5 to 5.7)
OG0023.0(2.9 to 4.3)
OG0033.3(2.9 to 5.6)
OG0043.0(2.8 to 5.0)
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00026
OG0019
OG00281
OG00350
OG00431
Title
Denominators
Categories
Title
Measurements
OG000NA(54.9 to NA)Insufficient number of participants with events
OG00111.2(0.3 to NA)Insufficient number of participants with events
OG002NA(52.7 to NA)Insufficient number of participants with events
OG003NA(52.7 to NA)Insufficient number of participants with events
OG004NA(NA to NA)Insufficient number of participants with events
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00024
OG0015
OG00279
OG00349
OG00430
Title
Denominators
Categories
Title
Measurements
OG0003.9(2.8 to 5.6)
OG0011.6(0.5 to 5.7)
OG0025.6(5.0 to 6.0)
OG0035.7(3.7 to 6.2)
OG0045.6(3.1 to 6.0)
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00024
OG0015
OG00279
OG00349
OG00430
Title
Denominators
Categories
Title
Measurements
OG000NA(54.9 to NA)Insufficient number of participants with events
OG001NA(1.0 to NA)Insufficient number of participants with events.
OG002NA(49.9 to NA)Insufficient number of participants with events
OG003NA(49.9 to NA)Insufficient number of participants with events
OG004NA(NA to NA)Insufficient number of participants with events
OG002
Cohort 3
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.
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
Title
Measurements
OG000NA(87.00 to NA)Insufficient number of participants with events
OG0016.67(0.95 to 12.16)
OG002NA(NA to NA)Insufficient number of participants with events
OG003NA(NA to NA)Insufficient number of participants with events
OG004NA(NA to NA)Insufficient number of participants with events
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00027
OG0015
OG00281
OG00351
OG00430
Title
Denominators
Categories
Title
Measurements
OG0000.7(0.5 to 1.8)
OG0012.5(0.5 to 2.8)
OG0021.2(0.9 to 1.4)
OG0031.2(0.9 to 1.4)
OG0041.0(0.7 to 1.8)
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00027
OG0015
OG00281
OG00351
OG00430
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Insufficient number of participants with events
OG001NA(1.9 to NA)Insufficient number of participants with events
OG002NA(NA to NA)Insufficient number of participants with events
OG003NA(NA to NA)Insufficient number of participants with events
OG004NA(NA to NA)Insufficient number of participants with events
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00024
OG0015
OG00279
OG00349
OG00430
Title
Denominators
Categories
Title
Measurements
OG000NA(75.83 to NA)Insufficient number of participants with events
OG001NA(1.87 to NA)Insufficient number of participants with events
OG002NA(NA to NA)Insufficient number of participants with events
OG003NA(NA to NA)Insufficient number of participants with events
OG004NA(NA to NA)Insufficient number of participants with events
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Insufficient number of participants with events
OG00113.63(4.67 to NA)Insufficient number of participants with events
OG002NA(NA to NA)Insufficient number of participants with events
OG003NA(NA to NA)Insufficient number of participants with events
OG004NA(NA to NA)Insufficient number of participants with events
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.
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
Title
Measurements
OG00069.0(49.2 to 84.7)
OG00129.4(10.3 to 56.0)
OG00284.5(75.0 to 91.5)
OG00390.2(78.6 to 96.7)
OG00475.8(57.7 to 88.9)
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
Title
Measurements
OG00027.6(12.7 to 47.2)
OG00111.8(1.5 to 36.4)
OG00242.9(32.1 to 54.1)
OG00349.0(34.8 to 63.4)
OG00433.3(18.0 to 51.8)
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
12 months
Title
Measurements
OG00089.7(72.6 to 97.8)
OG00158.8(32.9 to 81.6)
OG00296.4(89.9 to 99.3)
OG00398.0(89.6 to 100.0)
OG00493.9(79.8 to 99.3)
24 months
Title
Measurements
OG00089.7(72.6 to 97.8)
OG00158.8(32.9 to 81.6)
OG00296.4(89.9 to 99.3)
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
12 months
Title
Measurements
OG00075.9(56.5 to 89.7)
OG00141.2(18.4 to 67.1)
OG00292.9(85.1 to 97.3)
OG00396.1(86.5 to 99.5)
OG00487.9(71.8 to 96.6)
24 months
Title
Measurements
OG00082.8(64.2 to 94.2)
OG00141.2(18.4 to 67.1)
OG00294.0(86.7 to 98.0)
OG003
OG002
Cohort 3
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.
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.
Units
Counts
Participants
OG00029
OG00117
OG00284
OG00351
OG00433
Title
Denominators
Categories
12 months
Title
Measurements
OG00041.4(23.5 to 61.1)
OG00129.4(10.3 to 56.0)
OG00252.4(41.2 to 63.4)
OG00356.9(42.2 to 70.7)
OG00445.5(28.1 to 63.6)
24 months
Title
Measurements
OG00055.2(35.7 to 73.6)
OG00129.4(10.3 to 56.0)
OG00270.2(59.3 to 79.7)
OG003
36 months
Title
Measurements
OG00062.1(42.3 to 79.3)
OG00129.4(10.3 to 56.0)
OG00277.4(67.0 to 85.8)
OG003
48 months
Title
Measurements
OG00062.1(42.3 to 79.3)
OG00129.4(10.3 to 56.0)
OG00282.1(72.3 to 89.6)
OG003
60 months
Title
Measurements
OG00065.5(45.7 to 82.1)
OG00129.4(10.3 to 56.0)
OG00283.3(73.6 to 90.6)
OG003
72 months
Title
Measurements
OG00065.5(45.7 to 82.1)
OG00129.4(10.3 to 56.0)
OG00284.5(75.0 to 91.5)
OG003
84 months
Title
Measurements
OG00065.5(45.7 to 82.1)
OG00129.4(10.3 to 56.0)
OG00284.5(75.0 to 91.5)
OG003
90 months
Title
Measurements
OG00069.0(49.2 to 84.7)
OG00129.4(10.3 to 56.0)
OG00284.5(75.0 to 91.5)
OG003
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
OG004
Cohort 3b
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.