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

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ClinicalTrials.gov Identifier: NCT00777036
Recruitment Status : Active, not recruiting
First Posted : October 22, 2008
Results First Posted : January 5, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Intervention Drug: Dasatinib
Enrollment 145

Recruitment Details Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).
Pre-assignment Details A total of 145 participants were enrolled and 130 participants were treated in the study. Reasons for non-treatment include 2 withdrew consent, 1 died, 11 failed to meet study criteria, and 1 other non-specified.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen. Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen. Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Period Title: On Treatment
Started 29 17 84
Completed 14 [1] 1 [1] 61 [1]
Not Completed 15 16 23
Reason Not Completed
Reason Not Specified             4             7             12
Failure to Meet Study Criteria             0             1             0
Non-compliance with Study Drug             1             0             0
Maximum Clinical Benefit             2             0             1
Withdrawal by Subject             3             2             3
Death             0             2             0
Study Drug Toxicity             0             0             1
Progressive Disease             5             4             6
[1]
Completed = Still on treatment
Period Title: Follow-Up
Started 14 [1] 13 [1] 23 [1]
Completed 9 [2] 5 [2] 19 [2]
Not Completed 5 8 4
Reason Not Completed
Lost to Follow-up             1             0             0
Reason Not Specified             2             0             0
Withdrawal by Subject             1             0             4
Death             1             8             0
[1]
Not all participants who discontinued treatment entered the follow-up period
[2]
Completed = Still in Follow-up
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Total
Hide Arm/Group Description Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen. Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen. Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen. Total of all reporting groups
Overall Number of Baseline Participants 29 17 84 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 17 participants 84 participants 130 participants
12.60  (4.774) 12.10  (3.680) 11.95  (4.418) 12.12  (4.388)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 17 participants 84 participants 130 participants
< 2 years 1 0 2 3
>= 2 to < 7 years 3 2 10 15
>= 7 to < 12 years 6 6 28 40
>= 12 to < 18 years 17 9 44 70
>= 18 years 2 0 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 17 participants 84 participants 130 participants
Female
16
  55.2%
9
  52.9%
39
  46.4%
64
  49.2%
Male
13
  44.8%
8
  47.1%
45
  53.6%
66
  50.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 17 participants 84 participants 130 participants
Hispanic or Latino
2
   6.9%
0
   0.0%
5
   6.0%
7
   5.4%
Not Hispanic or Latino
4
  13.8%
0
   0.0%
20
  23.8%
24
  18.5%
Unknown or Not Reported
23
  79.3%
17
 100.0%
59
  70.2%
99
  76.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 17 participants 84 participants 130 participants
White
20
  69.0%
13
  76.5%
56
  66.7%
89
  68.5%
Black or African American
2
   6.9%
0
   0.0%
4
   4.8%
6
   4.6%
Asian
6
  20.7%
3
  17.6%
23
  27.4%
32
  24.6%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.8%
Other
1
   3.4%
1
   5.9%
0
   0.0%
2
   1.5%
1.Primary Outcome
Title Major Cytogenetic Response (MCyR) Rate
Hide Description Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Time Frame From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort 1
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.7
(72.6 to 97.8)
2.Primary Outcome
Title Complete Hematologic Response (CHR) Rate
Hide Description Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Time Frame From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort 2
Arm/Group Title Cohort 2
Hide Arm/Group Description:
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.4
(10.3 to 56.0)
3.Primary Outcome
Title Complete Cytogenetic Response (CCyR) Rate
Hide Description Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
Time Frame From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort 3
Arm/Group Title Cohort 3
Hide Arm/Group Description:
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.0
(86.7 to 98.0)
4.Secondary Outcome
Title Major Cytogenetic Response (MCyR) Rate in Cohort 2
Hide Description Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.
Time Frame From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort 2
Arm/Group Title Cohort 2
Hide Arm/Group Description:
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
58.8
(32.9 to 81.6)
5.Secondary Outcome
Title Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
Hide Description Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.
Time Frame From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohorts 1 and 3
Arm/Group Title Cohort 1 Cohort 3
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.1
(77.2 to 99.2)
96.4
(89.9 to 99.3)
6.Secondary Outcome
Title Rate of Best Cytogenetic Response
Hide Description The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm.
Time Frame From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Unit of Measure: percentage of participants
Complete (0%) 82.8 29.4 94.0 96.1 90.9
Partial (>0% - 35%) 6.9 23.5 2.4 2.0 3.0
Minor (>35% - 65%) 3.4 0 0 0 0
Minimal (>65% - 95%) 3.4 0 1.2 2.0 0
No Response (>95% - 100%) 0 5.9 0 0 0
Unable to Determine 3.4 41.2 2.4 0 6.1
7.Secondary Outcome
Title Time to Major Cytogenetic Response (MCyR)
Hide Description Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR.
Time Frame From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with MCyR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 26 17 81 50 31
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(2.8 to 4.1)
1.6
(0.5 to 5.7)
3.0
(2.9 to 4.3)
3.3
(2.9 to 5.6)
3.0
(2.8 to 5.0)
8.Secondary Outcome
Title Duration of Major Cytogenetic Response (MCyR)
Hide Description Duration of MCyR will be computed from the first day criteria are met for MCyR until the date 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.
Time Frame From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with MCyR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 26 9 81 50 31
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(54.9 to NA)
11.2 [2] 
(0.3 to NA)
NA [1] 
(52.7 to NA)
NA [1] 
(52.7 to NA)
NA [1] 
(NA to NA)
[1]
Median not reached
[2]
Upper 95% confidence limit not estimable
9.Secondary Outcome
Title Time to Complete Cytogenetic Response (CCyR)
Hide Description Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR.
Time Frame From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with CCyR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 24 7 79 49 30
Median (95% Confidence Interval)
Unit of Measure: months
3.9
(2.8 to 5.6)
1.6
(0.5 to 5.7)
5.6
(5.0 to 6.0)
5.7
(3.7 to 6.2)
5.6
(3.1 to 6.0)
10.Secondary Outcome
Title Duration of Complete Cytogenetic Response (CCyR)
Hide Description Duration of CCyR will be computed from the first day criteria are met for CCyR until the date 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.
Time Frame From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants who achieved CCyR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 24 5 79 49 30
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(54.9 to NA)
NA [1] 
(1.0 to NA)
NA [1] 
(49.9 to NA)
NA [1] 
(49.9 to NA)
NA [1] 
(NA to NA)
[1]
Median not reached
11.Secondary Outcome
Title Progression-Free Survival (PFS) Rate at 2 Years
Hide Description

PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation.

Disease Progression was defined as any of the following criteria:

  • For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose
  • Increasing WBC
  • Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood)
  • Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir
  • Death from any case during treatment
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
81.7
(61.4 to 92.0)
20.5
(3.7 to 46.4)
95.1
(87.4 to 98.1)
94.0
(82.6 to 98.0)
96.8
(79.2 to 99.5)
12.Secondary Outcome
Title Time to Complete Hematologic Response (CHR)
Hide Description Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
Time Frame From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with CHR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 27 5 81 51 30
Median (95% Confidence Interval)
Unit of Measure: months
0.7
(0.5 to 1.8)
2.5
(0.5 to 2.8)
1.2
(0.9 to 1.4)
1.2
(0.9 to 1.4)
1.0
(0.7 to 1.8)
13.Secondary Outcome
Title Duration of Complete Hematologic Response (CHR)
Hide Description Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.
Time Frame From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with CCyR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 27 5 81 51 30
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(1.9 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median not reached
14.Secondary Outcome
Title Disease-Free Survival Rate at 2 Years
Hide Description Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized treated participants with response of CCyR or CHR
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 24 5 79 49 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
86.9
(64.6 to 95.6)
60.0
(12.6 to 88.2)
98.7
(91.2 to 99.8)
97.9
(86.1 to 99.7)
100
(100 to 100)
15.Secondary Outcome
Title Overall Survival (OS) Rate at 2 Years
Hide Description OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
96.4
(77.2 to 99.5)
32.2
(10.6 to 56.4)
100
(100 to 100)
100
(100 to 100)
100
(100 to 100)
16.Secondary Outcome
Title Major Molecular Response (MMR) Rate
Hide Description Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant’s individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.
Time Frame From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.1
(42.3 to 79.3)
29.4
(10.3 to 56.0)
79.8
(69.6 to 87.7)
88.2
(76.1 to 95.6)
66.7
(48.2 to 82.0)
17.Secondary Outcome
Title Complete Molecular Response (CMR) Rate
Hide Description Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Time Frame From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
24.1
(10.3 to 43.5)
17.6
(3.8 to 43.4)
29.8
(20.3 to 40.7)
43.1
(29.3 to 57.8)
9.1
(1.9 to 24.3)
18.Secondary Outcome
Title Major Cytogenetic Response (MCyR) Rate up to 2 Years
Hide Description Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12 months
89.7
(72.6 to 97.8)
58.8
(32.9 to 81.6)
96.4
(89.9 to 99.3)
98.0
(89.6 to 100.0)
93.9
(79.8 to 99.3)
24 months
89.7
(72.6 to 97.8)
58.8
(32.9 to 81.6)
96.4
(89.9 to 99.3)
98.0
(89.6 to 100.0)
93.9
(79.8 to 99.3)
19.Secondary Outcome
Title Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Hide Description Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12 months
75.9
(56.5 to 89.7)
41.2
(18.4 to 67.1)
92.9
(85.1 to 97.3)
96.1
(86.5 to 99.5)
87.9
(71.8 to 96.6)
24 months
82.8
(64.2 to 94.2)
41.2
(18.4 to 67.1)
94.0
(86.7 to 98.0)
96.1
(86.5 to 99.5)
90.9
(75.7 to 98.1)
20.Secondary Outcome
Title Major Molecular Response (MMR) Rate up to 2 Years
Hide Description Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant’s individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12 months
41.4
(23.5 to 61.1)
23.5
(6.8 to 49.9)
52.4
(41.2 to 63.4)
56.9
(42.2 to 70.7)
45.5
(28.1 to 63.6)
24 months
55.2
(35.7 to 73.6)
29.4
(10.3 to 56.0)
70.2
(59.3 to 79.7)
74.5
(60.4 to 85.7)
63.6
(45.1 to 79.6)
21.Secondary Outcome
Title Complete Molecular Response (CMR) Rate up to 2 Years
Hide Description Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized treated participants
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 3a Cohort 3b
Hide Arm/Group Description:
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Overall Number of Participants Analyzed 29 17 84 51 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
12 months
6.9
(0.8 to 22.8)
11.8
(1.5 to 36.4)
8.3
(3.4 to 16.4)
9.8
(3.3 to 21.4)
6.1
(0.7 to 20.2)
24 months
17.2
(5.8 to 35.8)
11.8
(1.5 to 36.4)
21.4
(13.2 to 31.7)
29.4
(17.5 to 43.8)
9.1
(1.9 to 24.3)
Time Frame From date of first dose of study therapy to date of last dose plus 30 days (assessed up to September 2016, approximately 90 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 3a Cohort 3b Cohort 1 Cohort 2: BP-CML Only Cohort 2: Ph+ ALL Only
Hide Arm/Group Description Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen. Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen. Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen. Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen. Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
All-Cause Mortality
Cohort 3a Cohort 3b Cohort 1 Cohort 2: BP-CML Only Cohort 2: Ph+ ALL Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 3a Cohort 3b Cohort 1 Cohort 2: BP-CML Only Cohort 2: Ph+ ALL Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/51 (37.25%)   9/33 (27.27%)   13/29 (44.83%)   7/8 (87.50%)   6/9 (66.67%) 
Blood and lymphatic system disorders           
Anaemia  1  3/51 (5.88%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Febrile neutropenia  1  2/51 (3.92%)  1/33 (3.03%)  0/29 (0.00%)  2/8 (25.00%)  3/9 (33.33%) 
Leukocytosis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  1/9 (11.11%) 
Leukopenia  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Lymphadenopathy  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Neutropenia  1  0/51 (0.00%)  1/33 (3.03%)  2/29 (6.90%)  2/8 (25.00%)  0/9 (0.00%) 
Cardiac disorders           
Left ventricular dysfunction  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  2/51 (3.92%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Anal ulcer  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Colitis  1  1/51 (1.96%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  1/9 (11.11%) 
Diarrhoea  1  0/51 (0.00%)  3/33 (9.09%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Enteritis  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Gastrointestinal haemorrhage  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Haematochezia  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Pancreatitis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Rectal haemorrhage  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Stomatitis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Vomiting  1  0/51 (0.00%)  3/33 (9.09%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
General disorders           
Chills  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Disease progression  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Fatigue  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Oedema peripheral  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Pain  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Pyrexia  1  2/51 (3.92%)  3/33 (9.09%)  2/29 (6.90%)  2/8 (25.00%)  0/9 (0.00%) 
Hepatobiliary disorders           
Hepatic function abnormal  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Immune system disorders           
Drug hypersensitivity  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Infections and infestations           
Bacterial sepsis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Cellulitis  1  0/51 (0.00%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Device related infection  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Gastroenteritis  1  1/51 (1.96%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Gastrointestinal infection  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Infection  1  1/51 (1.96%)  0/33 (0.00%)  2/29 (6.90%)  1/8 (12.50%)  0/9 (0.00%) 
Meningitis aseptic  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Myringitis  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Oral herpes  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  2/8 (25.00%)  0/9 (0.00%) 
Otitis externa  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Periorbital cellulitis  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Sepsis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Upper aerodigestive tract infection  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Upper respiratory tract infection  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications           
Facial bones fracture  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Gun shot wound  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Hand fracture  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Overdose  1  1/51 (1.96%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Aspartate aminotransferase increased  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
White blood cell count decreased  1  2/51 (3.92%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Dehydration  1  2/51 (3.92%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders           
Osteonecrosis  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Pain in extremity  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Acute lymphocytic leukaemia recurrent  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Blast cell proliferation  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Blast crisis in myelogenous leukaemia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Chronic myeloid leukaemia  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Leukaemia  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Leukaemia recurrent  1  0/51 (0.00%)  2/33 (6.06%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Malignant neoplasm progression  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  2/8 (25.00%)  2/9 (22.22%) 
Nervous system disorders           
Arachnoiditis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Depressed level of consciousness  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Facial nerve disorder  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Headache  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Peripheral motor neuropathy  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Presyncope  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Seizure  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Syncope  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Psychiatric disorders           
Confusional state  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Personality change  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Suicidal ideation  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Reproductive system and breast disorders           
Genital haemorrhage  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Uterine haemorrhage  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Pulmonary haemorrhage  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Respiratory failure  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders           
Rash maculo-papular  1  1/51 (1.96%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Surgical and medical procedures           
Bone marrow transplant  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Vascular disorders           
Jugular vein thrombosis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 3a Cohort 3b Cohort 1 Cohort 2: BP-CML Only Cohort 2: Ph+ ALL Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/51 (98.04%)   33/33 (100.00%)   27/29 (93.10%)   7/8 (87.50%)   9/9 (100.00%) 
Blood and lymphatic system disorders           
Anaemia  1  10/51 (19.61%)  5/33 (15.15%)  2/29 (6.90%)  2/8 (25.00%)  2/9 (22.22%) 
Febrile neutropenia  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Haemoglobinaemia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Leukopenia  1  3/51 (5.88%)  2/33 (6.06%)  2/29 (6.90%)  2/8 (25.00%)  0/9 (0.00%) 
Lymphadenopathy  1  1/51 (1.96%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Lymphopenia  1  1/51 (1.96%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Neutropenia  1  17/51 (33.33%)  8/33 (24.24%)  6/29 (20.69%)  4/8 (50.00%)  3/9 (33.33%) 
Pancytopenia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Thrombocytopenia  1  13/51 (25.49%)  7/33 (21.21%)  5/29 (17.24%)  4/8 (50.00%)  4/9 (44.44%) 
Ear and labyrinth disorders           
Ear pain  1  7/51 (13.73%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Hypoacusis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Eye disorders           
Dry eye  1  1/51 (1.96%)  2/33 (6.06%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Eye oedema  1  1/51 (1.96%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Eye pain  1  3/51 (5.88%)  1/33 (3.03%)  3/29 (10.34%)  0/8 (0.00%)  2/9 (22.22%) 
Periorbital oedema  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Vision blurred  1  3/51 (5.88%)  1/33 (3.03%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  18/51 (35.29%)  7/33 (21.21%)  10/29 (34.48%)  1/8 (12.50%)  2/9 (22.22%) 
Abdominal pain upper  1  12/51 (23.53%)  4/33 (12.12%)  8/29 (27.59%)  0/8 (0.00%)  0/9 (0.00%) 
Anal fissure  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Anal ulcer  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Colitis  1  3/51 (5.88%)  1/33 (3.03%)  1/29 (3.45%)  1/8 (12.50%)  1/9 (11.11%) 
Constipation  1  9/51 (17.65%)  5/33 (15.15%)  4/29 (13.79%)  2/8 (25.00%)  0/9 (0.00%) 
Diarrhoea  1  27/51 (52.94%)  12/33 (36.36%)  17/29 (58.62%)  3/8 (37.50%)  3/9 (33.33%) 
Dyspepsia  1  0/51 (0.00%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Flatulence  1  0/51 (0.00%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Gastritis  1  6/51 (11.76%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Gingival bleeding  1  2/51 (3.92%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Mouth ulceration  1  0/51 (0.00%)  2/33 (6.06%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Nausea  1  20/51 (39.22%)  10/33 (30.30%)  11/29 (37.93%)  3/8 (37.50%)  2/9 (22.22%) 
Oral pain  1  2/51 (3.92%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Stomatitis  1  2/51 (3.92%)  4/33 (12.12%)  0/29 (0.00%)  2/8 (25.00%)  1/9 (11.11%) 
Tongue ulceration  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Toothache  1  4/51 (7.84%)  1/33 (3.03%)  3/29 (10.34%)  0/8 (0.00%)  1/9 (11.11%) 
Vomiting  1  22/51 (43.14%)  11/33 (33.33%)  15/29 (51.72%)  3/8 (37.50%)  3/9 (33.33%) 
General disorders           
Asthenia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Chest pain  1  2/51 (3.92%)  0/33 (0.00%)  3/29 (10.34%)  0/8 (0.00%)  0/9 (0.00%) 
Chills  1  0/51 (0.00%)  3/33 (9.09%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Fatigue  1  10/51 (19.61%)  7/33 (21.21%)  8/29 (27.59%)  1/8 (12.50%)  2/9 (22.22%) 
Influenza like illness  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Malaise  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Mass  1  1/51 (1.96%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Mucosal inflammation  1  0/51 (0.00%)  2/33 (6.06%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Non-cardiac chest pain  1  3/51 (5.88%)  3/33 (9.09%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Oedema peripheral  1  2/51 (3.92%)  1/33 (3.03%)  3/29 (10.34%)  1/8 (12.50%)  0/9 (0.00%) 
Pain  1  6/51 (11.76%)  5/33 (15.15%)  3/29 (10.34%)  1/8 (12.50%)  1/9 (11.11%) 
Peripheral swelling  1  0/51 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Pyrexia  1  23/51 (45.10%)  10/33 (30.30%)  14/29 (48.28%)  1/8 (12.50%)  5/9 (55.56%) 
Immune system disorders           
Drug hypersensitivity  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Hypersensitivity  1  0/51 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Infections and infestations           
Abscess  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  1/9 (11.11%) 
Bronchitis  1  0/51 (0.00%)  1/33 (3.03%)  3/29 (10.34%)  0/8 (0.00%)  0/9 (0.00%) 
Cellulitis  1  3/51 (5.88%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Conjunctivitis  1  2/51 (3.92%)  2/33 (6.06%)  3/29 (10.34%)  0/8 (0.00%)  0/9 (0.00%) 
Ear infection  1  5/51 (9.80%)  3/33 (9.09%)  1/29 (3.45%)  0/8 (0.00%)  1/9 (11.11%) 
Febrile infection  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Folliculitis  1  2/51 (3.92%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Gastroenteritis  1  7/51 (13.73%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  1/9 (11.11%) 
Gastroenteritis viral  1  0/51 (0.00%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Gingivitis  1  1/51 (1.96%)  0/33 (0.00%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Herpes virus infection  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hordeolum  1  0/51 (0.00%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  1/9 (11.11%) 
Influenza  1  6/51 (11.76%)  1/33 (3.03%)  3/29 (10.34%)  0/8 (0.00%)  0/9 (0.00%) 
Localised infection  1  1/51 (1.96%)  2/33 (6.06%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Lower respiratory tract infection  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Nasopharyngitis  1  10/51 (19.61%)  4/33 (12.12%)  7/29 (24.14%)  0/8 (0.00%)  0/9 (0.00%) 
Oral herpes  1  4/51 (7.84%)  1/33 (3.03%)  0/29 (0.00%)  2/8 (25.00%)  0/9 (0.00%) 
Otitis media  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Pharyngitis  1  6/51 (11.76%)  1/33 (3.03%)  2/29 (6.90%)  2/8 (25.00%)  2/9 (22.22%) 
Rhinitis  1  7/51 (13.73%)  4/33 (12.12%)  3/29 (10.34%)  0/8 (0.00%)  1/9 (11.11%) 
Sinusitis  1  3/51 (5.88%)  2/33 (6.06%)  4/29 (13.79%)  0/8 (0.00%)  1/9 (11.11%) 
Tonsillitis  1  3/51 (5.88%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Tooth infection  1  3/51 (5.88%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Upper respiratory tract infection  1  16/51 (31.37%)  11/33 (33.33%)  9/29 (31.03%)  1/8 (12.50%)  1/9 (11.11%) 
Viral infection  1  3/51 (5.88%)  0/33 (0.00%)  3/29 (10.34%)  0/8 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications           
Arthropod bite  1  0/51 (0.00%)  2/33 (6.06%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Contusion  1  3/51 (5.88%)  4/33 (12.12%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Foot fracture  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Procedural pain  1  2/51 (3.92%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Sunburn  1  1/51 (1.96%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  3/51 (5.88%)  4/33 (12.12%)  4/29 (13.79%)  3/8 (37.50%)  1/9 (11.11%) 
Aspartate aminotransferase increased  1  3/51 (5.88%)  3/33 (9.09%)  3/29 (10.34%)  2/8 (25.00%)  0/9 (0.00%) 
Blood creatinine increased  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Blood lactate dehydrogenase increased  1  2/51 (3.92%)  4/33 (12.12%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Blood phosphorus decreased  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Blood urea increased  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Gamma-glutamyltransferase increased  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Haemoglobin decreased  1  0/51 (0.00%)  5/33 (15.15%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Neutrophil count decreased  1  1/51 (1.96%)  5/33 (15.15%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Platelet count decreased  1  2/51 (3.92%)  11/33 (33.33%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Weight decreased  1  3/51 (5.88%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Weight increased  1  3/51 (5.88%)  3/33 (9.09%)  2/29 (6.90%)  1/8 (12.50%)  0/9 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  4/51 (7.84%)  1/33 (3.03%)  2/29 (6.90%)  1/8 (12.50%)  0/9 (0.00%) 
Fluid retention  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Hypercalcaemia  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Hyperkalaemia  1  0/51 (0.00%)  3/33 (9.09%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Hypermagnesaemia  1  1/51 (1.96%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hypernatraemia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hyperphosphataemia  1  0/51 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hyperuricaemia  1  0/51 (0.00%)  4/33 (12.12%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hypoalbuminaemia  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hypocalcaemia  1  2/51 (3.92%)  3/33 (9.09%)  2/29 (6.90%)  1/8 (12.50%)  0/9 (0.00%) 
Hypokalaemia  1  2/51 (3.92%)  1/33 (3.03%)  0/29 (0.00%)  2/8 (25.00%)  1/9 (11.11%) 
Hypomagnesaemia  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hyponatraemia  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Hypophosphataemia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  11/51 (21.57%)  6/33 (18.18%)  6/29 (20.69%)  1/8 (12.50%)  1/9 (11.11%) 
Back pain  1  7/51 (13.73%)  6/33 (18.18%)  4/29 (13.79%)  1/8 (12.50%)  0/9 (0.00%) 
Bone pain  1  5/51 (9.80%)  0/33 (0.00%)  1/29 (3.45%)  1/8 (12.50%)  3/9 (33.33%) 
Coccydynia  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Groin pain  1  3/51 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Muscle spasms  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  1/9 (11.11%) 
Musculoskeletal chest pain  1  1/51 (1.96%)  4/33 (12.12%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Musculoskeletal pain  1  5/51 (9.80%)  7/33 (21.21%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Musculoskeletal stiffness  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Myalgia  1  3/51 (5.88%)  6/33 (18.18%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Neck pain  1  2/51 (3.92%)  2/33 (6.06%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Pain in extremity  1  11/51 (21.57%)  14/33 (42.42%)  15/29 (51.72%)  2/8 (25.00%)  0/9 (0.00%) 
Pain in jaw  1  0/51 (0.00%)  1/33 (3.03%)  3/29 (10.34%)  0/8 (0.00%)  0/9 (0.00%) 
Tendonitis  1  0/51 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Skin papilloma  1  3/51 (5.88%)  3/33 (9.09%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Nervous system disorders           
Arachnoiditis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Brain oedema  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Dizziness  1  12/51 (23.53%)  3/33 (9.09%)  2/29 (6.90%)  1/8 (12.50%)  0/9 (0.00%) 
Dysgeusia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Facial paralysis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Headache  1  24/51 (47.06%)  15/33 (45.45%)  17/29 (58.62%)  3/8 (37.50%)  5/9 (55.56%) 
Neuropathy peripheral  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Paraesthesia  1  0/51 (0.00%)  1/33 (3.03%)  5/29 (17.24%)  0/8 (0.00%)  0/9 (0.00%) 
Somnolence  1  0/51 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Psychiatric disorders           
Anxiety  1  2/51 (3.92%)  3/33 (9.09%)  2/29 (6.90%)  1/8 (12.50%)  1/9 (11.11%) 
Depression  1  4/51 (7.84%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Insomnia  1  3/51 (5.88%)  2/33 (6.06%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders           
Dysuria  1  4/51 (7.84%)  1/33 (3.03%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Urinary incontinence  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Reproductive system and breast disorders           
Breast mass  1  1/51 (1.96%)  0/33 (0.00%)  1/29 (3.45%)  1/8 (12.50%)  0/9 (0.00%) 
Dysmenorrhoea  1  4/51 (7.84%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Menstruation irregular  1  0/51 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Vaginal discharge  1  3/51 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Vaginal haemorrhage  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  16/51 (31.37%)  9/33 (27.27%)  13/29 (44.83%)  1/8 (12.50%)  4/9 (44.44%) 
Dyspnoea  1  4/51 (7.84%)  2/33 (6.06%)  3/29 (10.34%)  1/8 (12.50%)  0/9 (0.00%) 
Epistaxis  1  5/51 (9.80%)  4/33 (12.12%)  3/29 (10.34%)  0/8 (0.00%)  1/9 (11.11%) 
Nasal congestion  1  3/51 (5.88%)  2/33 (6.06%)  3/29 (10.34%)  0/8 (0.00%)  0/9 (0.00%) 
Oropharyngeal pain  1  10/51 (19.61%)  11/33 (33.33%)  6/29 (20.69%)  1/8 (12.50%)  0/9 (0.00%) 
Pharyngeal erythema  1  3/51 (5.88%)  5/33 (15.15%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Productive cough  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Respiratory failure  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Respiratory tract congestion  1  0/51 (0.00%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Rhinalgia  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Rhinitis allergic  1  3/51 (5.88%)  3/33 (9.09%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Rhinorrhoea  1  11/51 (21.57%)  4/33 (12.12%)  3/29 (10.34%)  1/8 (12.50%)  1/9 (11.11%) 
Wheezing  1  3/51 (5.88%)  2/33 (6.06%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders           
Acne  1  1/51 (1.96%)  7/33 (21.21%)  3/29 (10.34%)  0/8 (0.00%)  1/9 (11.11%) 
Alopecia  1  5/51 (9.80%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Dermatitis acneiform  1  2/51 (3.92%)  2/33 (6.06%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Dry skin  1  2/51 (3.92%)  0/33 (0.00%)  4/29 (13.79%)  0/8 (0.00%)  1/9 (11.11%) 
Eczema  1  1/51 (1.96%)  1/33 (3.03%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Erythema  1  4/51 (7.84%)  2/33 (6.06%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Papule  1  1/51 (1.96%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Petechiae  1  1/51 (1.96%)  1/33 (3.03%)  1/29 (3.45%)  0/8 (0.00%)  1/9 (11.11%) 
Pruritus  1  7/51 (13.73%)  4/33 (12.12%)  5/29 (17.24%)  0/8 (0.00%)  0/9 (0.00%) 
Rash  1  14/51 (27.45%)  11/33 (33.33%)  8/29 (27.59%)  1/8 (12.50%)  1/9 (11.11%) 
Rash erythematous  1  3/51 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  0/9 (0.00%) 
Rash maculo-papular  1  0/51 (0.00%)  3/33 (9.09%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Rash papular  1  3/51 (5.88%)  1/33 (3.03%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Skin exfoliation  1  0/51 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/8 (0.00%)  1/9 (11.11%) 
Skin hypopigmentation  1  1/51 (1.96%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  1/9 (11.11%) 
Skin induration  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Urticaria  1  3/51 (5.88%)  3/33 (9.09%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Xeroderma  1  0/51 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/8 (0.00%)  0/9 (0.00%) 
Vascular disorders           
Haematoma  1  2/51 (3.92%)  3/33 (9.09%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Hot flush  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/8 (0.00%)  1/9 (11.11%) 
Hypertension  1  5/51 (9.80%)  4/33 (12.12%)  1/29 (3.45%)  0/8 (0.00%)  0/9 (0.00%) 
Phlebitis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Thrombophlebitis  1  0/51 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/8 (12.50%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00777036     History of Changes
Other Study ID Numbers: CA180-226
2008-002260-33 ( EudraCT Number )
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: December 6, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 29, 2018