A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia (DASISION)

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ClinicalTrials.gov Identifier: NCT00481247

Recruitment Status : Completed

First Posted : June 1, 2007

Results First Posted : March 15, 2011

Last Update Posted : February 15, 2017

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Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Myeloid Leukemia, Chronic
Interventions	Drug: Dasatinib Drug: Imatinib
Enrollment	547

Participant Flow

Recruitment Details
Pre-assignment Details	Of the 547 patients enrolled, 519 were randomized and 516 received treatment. Of the 28 who were enrolled but not randomized, 20 no longer met study criteria, 3 withdrew consent, 1 was lost to follow-up, and 4 withdrew for other reasons.


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400mg once ...
Arm/Group Description	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400mg once daily (QD)
Period Title: Overall Study
Started	259 ^[1]	260 ^[1]
Received Treatment	258	258
Completed	0	0
Not Completed	259	260
Reason Not Completed
Death	0	1
Disease progression	18	22
Intolerance	42	17
Treatment failure	10	14
AE unrelated to study drug	13	4
Withdrawal by Subject	8	13
Pregnancy	2	1
Lost to Follow-up	1	2
Poor compliance/noncompliance	1	7
Administrative reason by sponsor	157	162
Varied	6	15
Did not receive treatment	1	2
[1] Randomized

Baseline Characteristics

Arm/Group Title		Dasatinib	Imatinib	Total
Arm/Group Description		Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...	Total of all reporting groups
Arm/Group Description		Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)	Total of all reporting groups
Overall Number of Baseline Participants		259	260	519
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	259 participants	260 participants	519 participants
		46.4 (14.6)	47.1 (13.9)	46.7 (14.2)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	259 participants	260 participants	519 participants
<20 years		5	9	14
Between 21 and 45 years		123	102	225
Between 46 and 65 years		111	125	236
Between 66 and 75 years		13	20	33
>75 years		7	4	11
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	259 participants	260 participants	519 participants
	Female	115 44.4%	97 37.3%	212 40.8%
	Male	144 55.6%	163 62.7%	307 59.2%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	259 participants	260 participants	519 participants
White		132	143	275
Black/African American		2	1	3
Asian		108	95	203
Other		17	21	38
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	259 participants	260 participants	519 participants
ECOG score=0		213	205	418
ECOG score=1		46	53	99
ECOG score=2		0	2	2
		[1] Measure Description: ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
Number of Patients With Liver Involvement Measure Type: Number Unit of measure: Participants
	Number Analyzed	259 participants	260 participants	519 participants
		37	18	55
Number of Participants With Spleen Involvement Measure Type: Number Unit of measure: Participants
	Number Analyzed	259 participants	260 participants	519 participants
		83	71	154

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
Description	Cytogenetic response (CyR) is based on the prevalence of Philadelphia ...
Description	Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
Time Frame	Pretreatment, every 3 months up to 12 months

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	259	260
Measure Type: Number Unit of Measure: Participants
	204	177

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasatinib, Imatinib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0056
	Comments	A priori threshold for statistical significance=0.05.
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel test stratified by Hasford Score.

2.Secondary Outcome


Title	Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
Description	Cytogenetic response (CyR) is based on the prevalence of Philadelphia ...
Description	Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR. Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.
Time Frame	Years 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

All randomized participants who achieved cCCyR


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	215	204
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
At Year 2	98.0 (94.7 to 99.2)	96.9 (93.2 to 98.6)
At Year 3	96.9 (93.3 to 98.6)	95.7 (91.6 to 97.8)
At Year 4	95.6 (91.4 to 97.8)	95.7 (91.6 to 97.8)
At Year 5	93.1 (86.5 to 96.5)	91.0 (83.6 to 95.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasatinib, Imatinib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.55 to 1.13
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Percentage of Participants With Major Molecular Response (MMR) at Any Time
Description	Molecular response was assessed using BCR-ABL transcript levels measur...
Description	Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Time Frame	Planned total follow-up duration of 5 years

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	259	260
Measure Type: Number Unit of Measure: Percentage of participants
	76.4	64.2

4.Secondary Outcome


Title	Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
Description	The time to cCCyR for all randomized participants is defined as the ti...
Description	The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants. .
Time Frame	Day 1 to 5 years

Outcome Measure Data

Analysis Population Description

All randomized participants who achieved cCCyR


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	215	204
Median (95% Confidence Interval) Unit of Measure: Months
	3.1 (3.0 to 3.1)	5.8 (5.6 to 6.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasatinib, Imatinib
	Comments	Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 95% 1.20 to 1.77
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Time to Major Molecular Response (MMR) Overall
Description	The time to MMR for all randomized participants is defined as the time...
Description	The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.
Time Frame	Day 1 to 5 years

Outcome Measure Data

Analysis Population Description

All participants who received treatment and achieved MMR


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	198	167
Median (95% Confidence Interval) Unit of Measure: Months
	9.3 (8.8 to 11.8)	15.0 (12.2 to 18.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasatinib, Imatinib
	Comments	Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.54
	Confidence Interval	(2-Sided) 95% 1.25 to 1.89
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Percentage of Participants With Progression-free Survival (PFS)
Description	PFS was defined as the time from randomization until progression (any ...
Description	PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.
Time Frame	Participants were followed-up for at least 5 years

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	259	260
Measure Type: Number Unit of Measure: Percentage of participants
	88.9	89.2

7.Secondary Outcome


Title	Percentage of Participants With Overall Survival (OS)
Description	OS was defined as the time from randomization to the date of death. If...
Description	OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.
Time Frame	Participants were followed-up for at least 5 years

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	259	260
Measure Type: Number Unit of Measure: Percentage of participants
	90.9	89.6

8.Other Pre-specified Outcome


Title	Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths
Description	AE=any new untoward medical occurrence or worsening of a pre-existing ...
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame	From date of last person, first visit to date of last person, last visit (approximately 8 years)

Outcome Measure Data

Analysis Population Description

All treated participants


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	258	258
Measure Type: Number Unit of Measure: Participants
All AEs	251	251
All Drug-related AEs	224	231
Diarrhea	100	91
Pleural effusion	74	3
Nausea	40	74
Cough	68	28
Muscle spasms	14	63
Thrombocytopenia	61	50
Neutropenia	60	49
Headache	59	46
Pyrexia	58	51
Vomiting	43	54
SAEs	90	70
Drug-related SAEs	43	22
AEs leading to discontinuation	51	26
All deaths	26	26

9.Other Pre-specified Outcome


Title	Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results
Description	ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening...
Description	ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 <1000-500/mm^3; Grade 4 <500/mm^3. Hemoglobin: Grade 3 <8.0-6.5 g/dL; Grade 4 <6.5 g/dL. Platelets: Grade 3 <50,000-25,000/mm^3; Grade 4 <25,000/mm^3. ALT/AST: Grade 3 >5.0-20ULN; Grade 4 >20ULN. Total bilirubin: Grade 3 >3-10ULN; Grade 4 >10ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 >3.0-6.0ULN; Grade 4 >6.0ULN. Phosphate: Grade 3 <2.0-1.0 mg/dL; Grade 4 <1.0 mg/dL. Calcium: Grade 3 <7.0-6.0 mg/dL; Grade 4 <6.0 mg/dL. Potassium: Grade 3 <3.0-2.5 mmol/L; Grade 4 <2.5 mmol/L.
Time Frame	From date of last person, first visit to date of last person, last visit (approximately 8 years)

Outcome Measure Data

Analysis Population Description

Participants with laboratory assessments


Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description:	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description:	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
Overall Number of Participants Analyzed	256	257
Measure Type: Number Unit of Measure: Participants
Grade 3/4 Absolute neutrophil count	74	61
Grade 3/4 Hemoglobin	35	23
Grade 3/4 Platelets	56	37
Grade 3/4 Alanine aminotransferase (ALT)	2	4
Grade 3/4 Aspartate aminotransferase (AST)	2	3
Grade 3/4 Total bilirubin	3	0
Grade 3/4 Creatinine	3	2
Grade 3/4 Phosphate	19	79
Grade 3/4 Calcium	9	7
Grade 3/4 Potassium	0	8

Adverse Events

Time Frame	Randomization to end of study (December 2015)
Adverse Event Reporting Description	Study initiated: September 2007; End of Study: December 2015

Arm/Group Title	Dasatinib	Imatinib
Arm/Group Description	Tablets, oral, dasatinib 100 mg onc...	Tablets, oral, imatinib 400 mg once...
Arm/Group Description	Tablets, oral, dasatinib 100 mg once daily (QD)	Tablets, oral, imatinib 400 mg once daily (QD)
All-Cause Mortality
	Dasatinib	Imatinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Dasatinib	Imatinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	90/258 (34.88%)	70/258 (27.13%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	4/258 (1.55%)	1/258 (0.39%)
BICYTOPENIA ^† 1	0/258 (0.00%)	1/258 (0.39%)
BONE MARROW FAILURE ^† 1	1/258 (0.39%)	0/258 (0.00%)
FEBRILE NEUTROPENIA ^† 1	0/258 (0.00%)	3/258 (1.16%)
NEUTROPENIA ^† 1	1/258 (0.39%)	0/258 (0.00%)
PANCYTOPENIA ^† 1	1/258 (0.39%)	0/258 (0.00%)
THROMBOCYTOPENIA ^† 1	4/258 (1.55%)	4/258 (1.55%)
LEUKOCYTOSIS ^† 2	0/258 (0.00%)	1/258 (0.39%)
THROMBOCYTOSIS ^† 2	0/258 (0.00%)	1/258 (0.39%)
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION ^† 1	3/258 (1.16%)	1/258 (0.39%)
ANGINA UNSTABLE ^† 1	1/258 (0.39%)	0/258 (0.00%)
CARDIAC ARREST ^† 1	1/258 (0.39%)	0/258 (0.00%)
CARDIAC FAILURE ^† 1	1/258 (0.39%)	0/258 (0.00%)
CARDIAC FAILURE ACUTE ^† 1	0/258 (0.00%)	2/258 (0.78%)
CARDIAC FAILURE CONGESTIVE ^† 1	3/258 (1.16%)	0/258 (0.00%)
CARDIOMYOPATHY ^† 1	1/258 (0.39%)	0/258 (0.00%)
MYOCARDIAL INFARCTION ^† 1	3/258 (1.16%)	1/258 (0.39%)
SINOATRIAL BLOCK ^† 1	0/258 (0.00%)	1/258 (0.39%)
ACUTE CORONARY SYNDROME ^† 2	0/258 (0.00%)	1/258 (0.39%)
HYPERTENSIVE CARDIOMEGALY ^† 2	1/258 (0.39%)	0/258 (0.00%)
PERICARDIAL EFFUSION ^† 2	1/258 (0.39%)	0/258 (0.00%)
PERICARDITIS ^† 2	0/258 (0.00%)	1/258 (0.39%)
TACHYCARDIA ^† 2	1/258 (0.39%)	0/258 (0.00%)
Eye disorders
GLAUCOMA ^† 1	0/258 (0.00%)	1/258 (0.39%)
RETINAL DETACHMENT ^† 1	0/258 (0.00%)	1/258 (0.39%)
SCLERAL HAEMORRHAGE ^† 1	1/258 (0.39%)	0/258 (0.00%)
CATARACT ^† 3	0/258 (0.00%)	2/258 (0.78%)
VISUAL IMPAIRMENT ^† 3	1/258 (0.39%)	0/258 (0.00%)
Gastrointestinal disorders
ABDOMINAL HERNIA ^† 1	0/258 (0.00%)	1/258 (0.39%)
ABDOMINAL PAIN ^† 1	5/258 (1.94%)	1/258 (0.39%)
COLITIS ^† 1	2/258 (0.78%)	0/258 (0.00%)
DIARRHOEA ^† 1	5/258 (1.94%)	3/258 (1.16%)
GASTROINTESTINAL HAEMORRHAGE ^† 1	2/258 (0.78%)	2/258 (0.78%)
ILEUS ^† 1	2/258 (0.78%)	0/258 (0.00%)
MELAENA ^† 1	1/258 (0.39%)	0/258 (0.00%)
PROTEIN-LOSING GASTROENTEROPATHY ^† 1	1/258 (0.39%)	0/258 (0.00%)
TOOTHACHE ^† 1	1/258 (0.39%)	0/258 (0.00%)
UPPER GASTROINTESTINAL HAEMORRHAGE ^† 1	0/258 (0.00%)	1/258 (0.39%)
VOMITING ^† 1	2/258 (0.78%)	3/258 (1.16%)
ANAL FISSURE ^† 2	1/258 (0.39%)	0/258 (0.00%)
CHRONIC GASTRITIS ^† 2	1/258 (0.39%)	0/258 (0.00%)
CROHN'S DISEASE ^† 2	0/258 (0.00%)	1/258 (0.39%)
GASTRIC ULCER HAEMORRHAGE ^† 2	1/258 (0.39%)	0/258 (0.00%)
HAEMORRHOIDS ^† 2	0/258 (0.00%)	1/258 (0.39%)
INGUINAL HERNIA ^† 2	0/258 (0.00%)	1/258 (0.39%)
INTESTINAL OBSTRUCTION ^† 2	0/258 (0.00%)	1/258 (0.39%)
LARGE INTESTINAL ULCER ^† 2	1/258 (0.39%)	0/258 (0.00%)
LOWER GASTROINTESTINAL HAEMORRHAGE ^† 2	1/258 (0.39%)	0/258 (0.00%)
PANCREATIC DISORDER ^† 2	1/258 (0.39%)	0/258 (0.00%)
PANCREATITIS ^† 2	1/258 (0.39%)	0/258 (0.00%)
General disorders
FATIGUE ^† 1	2/258 (0.78%)	0/258 (0.00%)
GENERAL PHYSICAL HEALTH DETERIORATION ^† 1	0/258 (0.00%)	1/258 (0.39%)
OEDEMA ^† 1	0/258 (0.00%)	1/258 (0.39%)
PYREXIA ^† 1	3/258 (1.16%)	2/258 (0.78%)
CHEST PAIN ^† 2	0/258 (0.00%)	1/258 (0.39%)
DEVICE OCCLUSION ^† 2	1/258 (0.39%)	0/258 (0.00%)
PAIN ^† 2	1/258 (0.39%)	0/258 (0.00%)
Hepatobiliary disorders
HEPATITIS TOXIC ^† 1	0/258 (0.00%)	1/258 (0.39%)
BILE DUCT STONE ^† 2	1/258 (0.39%)	0/258 (0.00%)
CHOLECYSTITIS ^† 2	1/258 (0.39%)	2/258 (0.78%)
CHOLELITHIASIS ^† 2	2/258 (0.78%)	0/258 (0.00%)
Infections and infestations
ABSCESS ^† 1	1/258 (0.39%)	0/258 (0.00%)
BRONCHITIS ^† 1	2/258 (0.78%)	0/258 (0.00%)
CELLULITIS ^† 1	3/258 (1.16%)	0/258 (0.00%)
ERYSIPELAS ^† 1	2/258 (0.78%)	0/258 (0.00%)
GASTROENTERITIS ^† 1	2/258 (0.78%)	1/258 (0.39%)
INFECTION ^† 1	3/258 (1.16%)	0/258 (0.00%)
LOWER RESPIRATORY TRACT INFECTION ^† 1	1/258 (0.39%)	2/258 (0.78%)
MENINGOENCEPHALITIS BACTERIAL ^† 1	1/258 (0.39%)	0/258 (0.00%)
NEUTROPENIC SEPSIS ^† 1	0/258 (0.00%)	1/258 (0.39%)
PNEUMONIA ^† 1	3/258 (1.16%)	3/258 (1.16%)
SUBCUTANEOUS ABSCESS ^† 1	1/258 (0.39%)	0/258 (0.00%)
TOOTH INFECTION ^† 1	0/258 (0.00%)	1/258 (0.39%)
URINARY TRACT INFECTION ^† 1	0/258 (0.00%)	2/258 (0.78%)
ANAL ABSCESS ^† 2	1/258 (0.39%)	1/258 (0.39%)
ENTERITIS INFECTIOUS ^† 2	0/258 (0.00%)	1/258 (0.39%)
H1N1 INFLUENZA ^† 2	1/258 (0.39%)	0/258 (0.00%)
HEPATITIS VIRAL ^† 2	0/258 (0.00%)	1/258 (0.39%)
MENINGITIS VIRAL ^† 2	1/258 (0.39%)	0/258 (0.00%)
PERIRECTAL ABSCESS ^† 2	0/258 (0.00%)	1/258 (0.39%)
PYELONEPHRITIS ^† 2	0/258 (0.00%)	1/258 (0.39%)
SEPSIS ^† 2	1/258 (0.39%)	0/258 (0.00%)
UPPER RESPIRATORY TRACT INFECTION ^† 2	1/258 (0.39%)	0/258 (0.00%)
Injury, poisoning and procedural complications
ANKLE FRACTURE ^† 1	0/258 (0.00%)	1/258 (0.39%)
FEMUR FRACTURE ^† 1	1/258 (0.39%)	0/258 (0.00%)
OVERDOSE ^† 1	2/258 (0.78%)	2/258 (0.78%)
RADIUS FRACTURE ^† 1	1/258 (0.39%)	0/258 (0.00%)
TENDON RUPTURE ^† 1	0/258 (0.00%)	1/258 (0.39%)
UPPER LIMB FRACTURE ^† 1	1/258 (0.39%)	0/258 (0.00%)
FRACTURE ^† 2	1/258 (0.39%)	0/258 (0.00%)
HEAT STROKE ^† 2	1/258 (0.39%)	0/258 (0.00%)
MUSCLE RUPTURE ^† 2	1/258 (0.39%)	0/258 (0.00%)
PNEUMOTHORAX TRAUMATIC ^† 2	1/258 (0.39%)	0/258 (0.00%)
PROCEDURAL PAIN ^† 2	1/258 (0.39%)	0/258 (0.00%)
SKIN INJURY ^† 2	1/258 (0.39%)	0/258 (0.00%)
SUBDURAL HAEMATOMA ^† 2	0/258 (0.00%)	1/258 (0.39%)
WOUND ^† 2	0/258 (0.00%)	1/258 (0.39%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED ^† 1	0/258 (0.00%)	1/258 (0.39%)
ASPARTATE AMINOTRANSFERASE INCREASED ^† 1	0/258 (0.00%)	1/258 (0.39%)
BLOOD GLUCOSE INCREASED ^† 1	1/258 (0.39%)	0/258 (0.00%)
KLEBSIELLA TEST POSITIVE ^† 2	1/258 (0.39%)	0/258 (0.00%)
TRANSAMINASE INCREASED ^† 2	0/258 (0.00%)	1/258 (0.39%)
Metabolism and nutrition disorders
HYPERGLYCAEMIA ^† 1	0/258 (0.00%)	1/258 (0.39%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	0/258 (0.00%)	1/258 (0.39%)
BONE PAIN ^† 1	1/258 (0.39%)	0/258 (0.00%)
GROIN PAIN ^† 1	0/258 (0.00%)	1/258 (0.39%)
MYALGIA ^† 1	1/258 (0.39%)	0/258 (0.00%)
PAIN IN EXTREMITY ^† 1	0/258 (0.00%)	1/258 (0.39%)
FIBROMYALGIA ^† 2	1/258 (0.39%)	0/258 (0.00%)
GOUTY ARTHRITIS ^† 2	0/258 (0.00%)	1/258 (0.39%)
INTERVERTEBRAL DISC PROTRUSION ^† 2	0/258 (0.00%)	1/258 (0.39%)
JAW CYST ^† 2	1/258 (0.39%)	0/258 (0.00%)
PAIN IN JAW ^† 2	1/258 (0.39%)	0/258 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLAST CELL PROLIFERATION ^† 1	0/258 (0.00%)	2/258 (0.78%)
LYMPHOMA ^† 1	0/258 (0.00%)	1/258 (0.39%)
ADENOCARCINOMA OF COLON ^† 2	1/258 (0.39%)	0/258 (0.00%)
BASAL CELL CARCINOMA ^† 2	1/258 (0.39%)	0/258 (0.00%)
BLADDER NEOPLASM ^† 2	1/258 (0.39%)	0/258 (0.00%)
BLAST CELL IN MYELOGENOUS LEUKAEMIA ^† 2	3/258 (1.16%)	4/258 (1.55%)
COLON CANCER ^† 2	0/258 (0.00%)	1/258 (0.39%)
INTRADUCTAL PROLIFERATIVE BREAST LESION ^† 2	1/258 (0.39%)	0/258 (0.00%)
LUNG ADENOCARCINOMA ^† 2	1/258 (0.39%)	0/258 (0.00%)
NODAL MARGINAL ZONE B-CELL LYMPHOMA ^† 2	0/258 (0.00%)	1/258 (0.39%)
PROSTATE CANCER ^† 2	0/258 (0.00%)	3/258 (1.16%)
RECTAL ADENOCARCINOMA ^† 2	0/258 (0.00%)	1/258 (0.39%)
RECTOSIGMOID CANCER ^† 2	0/258 (0.00%)	1/258 (0.39%)
TRANSITIONAL CELL CARCINOMA ^† 2	1/258 (0.39%)	0/258 (0.00%)
Nervous system disorders
CARPAL TUNNEL SYNDROME ^† 1	1/258 (0.39%)	0/258 (0.00%)
CEREBRAL HAEMORRHAGE ^† 1	1/258 (0.39%)	0/258 (0.00%)
HEADACHE ^† 1	0/258 (0.00%)	1/258 (0.39%)
OPTIC NEURITIS ^† 1	1/258 (0.39%)	0/258 (0.00%)
SOMNOLENCE ^† 1	1/258 (0.39%)	0/258 (0.00%)
ALTERED STATE OF CONSCIOUSNESS ^† 2	1/258 (0.39%)	0/258 (0.00%)
HEADACHE ^† 2	0/258 (0.00%)	1/258 (0.39%)
HYDROCEPHALUS ^† 2	1/258 (0.39%)	0/258 (0.00%)
TRANSIENT ISCHAEMIC ATTACK ^† 2	2/258 (0.78%)	0/258 (0.00%)
Psychiatric disorders
SUICIDE ATTEMPT ^† 1	1/258 (0.39%)	0/258 (0.00%)
DEPRESSED MOOD ^† 2	0/258 (0.00%)	1/258 (0.39%)
DEPRESSION ^† 2	0/258 (0.00%)	1/258 (0.39%)
Renal and urinary disorders
CALCULUS URETERIC ^† 1	0/258 (0.00%)	1/258 (0.39%)
RENAL FAILURE ACUTE ^† 1	2/258 (0.78%)	0/258 (0.00%)
ACUTE KIDNEY INJURY ^† 2	0/258 (0.00%)	1/258 (0.39%)
PROTEINURIA ^† 2	1/258 (0.39%)	0/258 (0.00%)
URINARY BLADDER POLYP ^† 2	0/258 (0.00%)	1/258 (0.39%)
URINARY RETENTION ^† 2	0/258 (0.00%)	1/258 (0.39%)
UROGENITAL HAEMORRHAGE ^† 2	0/258 (0.00%)	1/258 (0.39%)
Reproductive system and breast disorders
MENORRHAGIA ^† 1	0/258 (0.00%)	1/258 (0.39%)
UTERINE HAEMORRHAGE ^† 1	0/258 (0.00%)	2/258 (0.78%)
OVARIAN CYST ^† 2	1/258 (0.39%)	0/258 (0.00%)
PROSTATITIS ^† 2	0/258 (0.00%)	1/258 (0.39%)
SCROTAL OEDEMA ^† 2	1/258 (0.39%)	0/258 (0.00%)
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	1/258 (0.39%)	0/258 (0.00%)
DYSPNOEA ^† 1	1/258 (0.39%)	0/258 (0.00%)
HAEMOPTYSIS ^† 1	1/258 (0.39%)	0/258 (0.00%)
HYPOXIA ^† 1	2/258 (0.78%)	0/258 (0.00%)
LUNG INFILTRATION ^† 1	1/258 (0.39%)	0/258 (0.00%)
PLEURAL EFFUSION ^† 1	13/258 (5.04%)	1/258 (0.39%)
PULMONARY HYPERTENSION ^† 1	7/258 (2.71%)	0/258 (0.00%)
ASTHMA ^† 2	0/258 (0.00%)	1/258 (0.39%)
PNEUMOTHORAX ^† 2	1/258 (0.39%)	0/258 (0.00%)
PULMONARY EMBOLISM ^† 2	1/258 (0.39%)	0/258 (0.00%)
Skin and subcutaneous tissue disorders
SKIN ULCER ^† 1	1/258 (0.39%)	0/258 (0.00%)
Vascular disorders
DEEP VEIN THROMBOSIS ^† 1	1/258 (0.39%)	1/258 (0.39%)
HAEMORRHAGE ^† 1	0/258 (0.00%)	1/258 (0.39%)
PHLEBITIS ^† 1	1/258 (0.39%)	0/258 (0.00%)
PERIPHERAL ARTERIAL OCCULUSIVE DISEASE ^† 2	0/258 (0.00%)	1/258 (0.39%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12.1 2 Term from vocabulary, MedDRA (18.1) 3 Term from vocabulary, MedDRA (17.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Dasatinib	Imatinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	216/258 (83.72%)	231/258 (89.53%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	38/258 (14.73%)	31/258 (12.02%)
LEUKOPENIA ^† 1	21/258 (8.14%)	28/258 (10.85%)
NEUTROPENIA ^† 1	60/258 (23.26%)	49/258 (18.99%)
THROMBOCYTOPENIA ^† 1	59/258 (22.87%)	48/258 (18.60%)
Eye disorders
EYELID OEDEMA ^† 1	7/258 (2.71%)	40/258 (15.50%)
PERIORBITAL OEDEMA ^† 2	4/258 (1.55%)	20/258 (7.75%)
Gastrointestinal disorders
ABDOMINAL PAIN ^† 1	36/258 (13.95%)	28/258 (10.85%)
ABDOMINAL PAIN UPPER ^† 1	22/258 (8.53%)	18/258 (6.98%)
CONSTIPATION ^† 1	21/258 (8.14%)	7/258 (2.71%)
DIARRHOEA ^† 1	99/258 (38.37%)	89/258 (34.50%)
DYSPEPSIA ^† 1	17/258 (6.59%)	22/258 (8.53%)
GASTRITIS ^† 1	23/258 (8.91%)	18/258 (6.98%)
NAUSEA ^† 1	40/258 (15.50%)	74/258 (28.68%)
VOMITING ^† 1	41/258 (15.89%)	52/258 (20.16%)
TOOTHACHE ^† 2	17/258 (6.59%)	10/258 (3.88%)
General disorders
ASTHENIA ^† 1	42/258 (16.28%)	37/258 (14.34%)
CHEST PAIN ^† 1	24/258 (9.30%)	13/258 (5.04%)
FACE OEDEMA ^† 1	14/258 (5.43%)	27/258 (10.47%)
FATIGUE ^† 1	40/258 (15.50%)	40/258 (15.50%)
INFLUENZA LIKE ILLNESS ^† 1	17/258 (6.59%)	13/258 (5.04%)
OEDEMA ^† 1	10/258 (3.88%)	24/258 (9.30%)
OEDEMA PERIPHERAL ^† 1	25/258 (9.69%)	32/258 (12.40%)
PYREXIA ^† 1	58/258 (22.48%)	50/258 (19.38%)
INFLUENZA LIKE ILLNESS ^† 2	23/258 (8.91%)	17/258 (6.59%)
Infections and infestations
NASOPHARYNGITIS ^† 1	32/258 (12.40%)	43/258 (16.67%)
UPPER RESPIRATORY TRACT INFECTION ^† 1	30/258 (11.63%)	28/258 (10.85%)
BRONCHITIS ^† 2	20/258 (7.75%)	14/258 (5.43%)
CONJUNCTIVITIS ^† 2	10/258 (3.88%)	17/258 (6.59%)
GASTROENTERITIS ^† 2	19/258 (7.36%)	10/258 (3.88%)
INFLUENZA ^† 2	20/258 (7.75%)	12/258 (4.65%)
URINARY TRACT INFECTION ^† 2	11/258 (4.26%)	13/258 (5.04%)
Investigations
HAEMOGLOBIN DECREASED ^† 1	30/258 (11.63%)	17/258 (6.59%)
WEIGHT INCREASED ^† 1	25/258 (9.69%)	33/258 (12.79%)
ALANINE AMINOTRANSFERASE INCREASE ^† 2	13/258 (5.04%)	7/258 (2.71%)
Metabolism and nutrition disorders
DECREASED APPETITE ^† 1	23/258 (8.91%)	13/258 (5.04%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	34/258 (13.18%)	38/258 (14.73%)
BACK PAIN ^† 1	34/258 (13.18%)	44/258 (17.05%)
MUSCLE SPASMS ^† 1	14/258 (5.43%)	63/258 (24.42%)
MUSCULOSKELETAL PAIN ^† 1	22/258 (8.53%)	19/258 (7.36%)
MYALGIA ^† 1	36/258 (13.95%)	39/258 (15.12%)
PAIN IN EXTREMITY ^† 1	28/258 (10.85%)	39/258 (15.12%)
Nervous system disorders
DIZZINESS ^† 1	28/258 (10.85%)	18/258 (6.98%)
HEADACHE ^† 1	59/258 (22.87%)	46/258 (17.83%)
Psychiatric disorders
INSOMNIA ^† 1	20/258 (7.75%)	16/258 (6.20%)
DEPRESSION ^† 2	5/258 (1.94%)	13/258 (5.04%)
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	68/258 (26.36%)	28/258 (10.85%)
DYSPNOEA ^† 1	36/258 (13.95%)	10/258 (3.88%)
PLEURAL EFFUSION ^† 1	69/258 (26.74%)	3/258 (1.16%)
OROPHARYNGEAL PAIN ^† 2	14/258 (5.43%)	11/258 (4.26%)
Skin and subcutaneous tissue disorders
PRURITUS ^† 1	15/258 (5.81%)	19/258 (7.36%)
RASH ^† 1	45/258 (17.44%)	44/258 (17.05%)
ACNE ^† 2	14/258 (5.43%)	1/258 (0.39%)
Vascular disorders
PALLOR ^† 1	7/258 (2.71%)	13/258 (5.04%)
HYPERTENSION ^† 2	26/258 (10.08%)	20/258 (7.75%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12.1 2 Term from vocabulary, MedDRA (18.1)

Limitations and Caveats

[Not Specified]

More Information

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

Layout table for Results Point of Contact information

Name/Title:	BMS Study Director
Organization:	Bristol-Myers Squibb
EMail:	Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.

Hughes TP, Saglio G, Quintas-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.

Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.

Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipina JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.

Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.

Layout table for additonal information

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00481247
Other Study ID Numbers:	CA180-056 2006-005712-27 ( EudraCT Number )
First Submitted:	May 30, 2007
First Posted:	June 1, 2007
Results First Submitted:	November 23, 2010
Results First Posted:	March 15, 2011
Last Update Posted:	February 15, 2017

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