Trial Outcomes & Findings for Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia (NCT NCT00103844)
NCT ID: NCT00103844
Last Updated: 2010-08-10
Results Overview
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; \>0% to 35% Ph+ cells in metaphase in bone marrow).
COMPLETED
PHASE2
150 participants
Week 12
2010-08-10
Participant Flow
166 subjects enrolled; 16 failed screening and were not treated (2 subjects were double-randomizations, 13 subjects failed inclusion criteria, 1 subject withdrew consent during screening.)
Participant milestones
| Measure |
Dasatinib First
Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
|
Imatinib First
Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
49
|
|
Overall Study
Crossed Over
|
22
|
40
|
|
Overall Study
COMPLETED
|
101
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=49 Participants
Imatinib 400 mg BID
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 21 and 45 years
|
36 participants
n=5 Participants
|
15 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Age, Customized
Between 46 and 65 years
|
48 participants
n=5 Participants
|
28 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Age, Customized
Between 66 and 75 years
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
>75 years
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age Continuous
|
51 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
50 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
51 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
87 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Score=0 (fully active)
|
71 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Score=1 (ambulatory, light/sedentary work)
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Score=2 (ambulatory, all selfcare, unable to work)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Score=3 (limited selfcare, some bed confinement)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Score=4 (completely disabled)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Score=5 (dead)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)
Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized subjects
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; \>0% to 35% Ph+ cells in metaphase in bone marrow).
Outcome measures
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=49 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
|
36 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (\>0% to 35% Ph+ cells in metaphase in bone marrow).
Outcome measures
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=49 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
MCyR at Any Time Prior to Crossover
MCyR (CCyR + PCyR)
|
54 Participants
|
16 Participants
|
|
MCyR at Any Time Prior to Crossover
CCyR (0% Ph+ cells)
|
44 Participants
|
9 Participants
|
|
MCyR at Any Time Prior to Crossover
PCyR (>0% to 35% Ph+ cells)
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 months, 18 monthsPercentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Outcome measures
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=49 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Duration of MCyR at 12 Months and 18 Months
12 months
|
92 percentage of participants.
|
74 percentage of participants.
|
|
Duration of MCyR at 12 Months and 18 Months
18 months
|
90 percentage of participants.
|
74 percentage of participants.
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: In the imatinib group, the 24 months timepoint was beyond the maximum observed time.
Percentage of participants who achieved MCyR and did not progress at 24 months.
Outcome measures
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
Imatinib 400 mg BID
|
|---|---|---|
|
Duration of MCyR at 24 Months
|
90 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.Population: Population consists of the number of responders in each treatment group
Median time from first dosing date to date of MCyR
Outcome measures
| Measure |
Dasatinib
n=54 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=16 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Time to MCyR Prior to Crossover
|
2.8 months
Interval 0.7 to 19.3
|
2.8 months
Interval 2.4 to 5.7
|
SECONDARY outcome
Timeframe: Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Outcome measures
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=49 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Complete Hematologic Response (CHR) at Any Time Prior to Crossover
|
94 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 12 months, 24 monthsPopulation: Number of participants achieving CHR in each treatment group
Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Outcome measures
| Measure |
Dasatinib
n=94 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=40 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Duration of Complete Hematologic Response (CHR)
12 months
|
92 percentage of participants
|
82 percentage of participants
|
|
Duration of Complete Hematologic Response (CHR)
24 months
|
84 percentage of participants
|
73 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.Population: Number of participants achieving CHR in each treatment group
Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Outcome measures
| Measure |
Dasatinib
n=94 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=40 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Time to CHR Prior to Crossover
|
2.1 weeks
Interval 2.0 to 15.9
|
2.1 weeks
Interval 2.0 to 6.1
|
SECONDARY outcome
Timeframe: Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.Population: Participants assessed for MMR only
Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.
Outcome measures
| Measure |
Dasatinib
n=99 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=45 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Major Molecular Response (MMR)
|
29 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.Population: Participants evaluable for response after crossover
Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Outcome measures
| Measure |
Dasatinib
n=39 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=20 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
CHR After Crossover
|
37 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurementsPopulation: Participants evaluable for after crossover response
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (\>0% to 35% Ph+ cells in metaphase in bone marrow).
Outcome measures
| Measure |
Dasatinib
n=39 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=20 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Cytogenetic Response After Crossover
Complete Cytogenetic Response (CCyR)
|
15 Participants
|
0 Participants
|
|
Cytogenetic Response After Crossover
Major Cytogenetic Response (MCyR)
|
19 Participants
|
3 Participants
|
|
Cytogenetic Response After Crossover
Partial Cytogenetic Response (PCyR)
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Continuously from baseline through 2 yearsPopulation: All treated participants
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Outcome measures
| Measure |
Dasatinib
n=101 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
n=49 Participants
Imatinib 400 mg BID
|
|---|---|---|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Any Adverse Event (AE)
|
100 Participants
|
45 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Grade 3-4 AEs
|
67 Participants
|
21 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Drug-related AEs
|
94 Participants
|
44 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Drug-related Grade 3-4 AEs
|
62 Participants
|
19 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Death within 30 days of last dose
|
1 Participants
|
0 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Drug-related Serious AEs
|
28 Participants
|
3 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
AEs leading to discontinuation
|
23 Participants
|
10 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Fluid Retention AEs - Overall
|
39 Participants
|
21 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Fluid Retention AEs - Superficial Edema
|
20 Participants
|
21 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Fluid Retention AEs - Pleural Effusion
|
25 Participants
|
0 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Fluid Retention AEs - Other
|
9 Participants
|
0 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Grade 3-4 Hematologic Toxicity - Anemia
|
20 Participants
|
4 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Grade 3-4 Hematologic Toxicity - Thrombocytopenia
|
58 Participants
|
7 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Grade 3-4 Hematologic Toxicity - Neutropenia
|
64 Participants
|
19 Participants
|
|
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Grade 3-4 Hematologic Toxicity - Leukopenia
|
24 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.Population: Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed.
Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, \& functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, \& FWB score change of 3 or more, \& SWB score change of 2 or more=minimal clinical important change.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.Population: Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report.
Number of participants from which blood samples were collected for population PK studies.
Outcome measures
| Measure |
Dasatinib
n=78 Participants
Dasatinib 70 mg twice a day (BID)
|
Imatinib
Imatinib 400 mg BID
|
|---|---|---|
|
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
|
78 participants
|
—
|
Adverse Events
DASATINIB
IMATINIB
Serious adverse events
| Measure |
DASATINIB
n=101 participants at risk
Dasatinib 70 mg twice a day (BID)
|
IMATINIB
n=49 participants at risk
Imatinib 400 mg BID
|
|---|---|---|
|
Eye disorders
CATARACT
|
0.99%
1/101
|
0.00%
0/49
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/101
|
2.0%
1/49
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.99%
1/101
|
0.00%
0/49
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.0%
3/101
|
0.00%
0/49
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.99%
1/101
|
0.00%
0/49
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.99%
1/101
|
0.00%
0/49
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
0.99%
1/101
|
0.00%
0/49
|
|
Vascular disorders
HYPERTENSION
|
0.99%
1/101
|
0.00%
0/49
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.99%
1/101
|
0.00%
0/49
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.99%
1/101
|
0.00%
0/49
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/101
|
2.0%
1/49
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.99%
1/101
|
0.00%
0/49
|
|
Gastrointestinal disorders
GASTRITIS
|
0.99%
1/101
|
0.00%
0/49
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/101
|
2.0%
1/49
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.99%
1/101
|
0.00%
0/49
|
|
Gastrointestinal disorders
ANORECTAL DISORDER
|
0.99%
1/101
|
0.00%
0/49
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.99%
1/101
|
0.00%
0/49
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
2.0%
2/101
|
0.00%
0/49
|
|
Infections and infestations
MUMPS
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
SEPSIS
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
INFECTION
|
2.0%
2/101
|
0.00%
0/49
|
|
Infections and infestations
PNEUMONIA
|
6.9%
7/101
|
0.00%
0/49
|
|
Infections and infestations
CELLULITIS
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
APPENDICITIS
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.99%
1/101
|
0.00%
0/49
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.99%
1/101
|
0.00%
0/49
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.99%
1/101
|
0.00%
0/49
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.99%
1/101
|
0.00%
0/49
|
|
Surgical and medical procedures
UTERINE DILATION AND CURETTAGE
|
0.99%
1/101
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.0%
2/101
|
0.00%
0/49
|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.0%
3/101
|
0.00%
0/49
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.9%
6/101
|
0.00%
0/49
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/101
|
2.0%
1/49
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.99%
1/101
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.99%
1/101
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.99%
1/101
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.99%
1/101
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/101
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.99%
1/101
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
OSTEOCHONDROSIS
|
0.00%
0/101
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.0%
5/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.99%
1/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
9.9%
10/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.99%
1/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.99%
1/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.0%
2/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.99%
1/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.99%
1/101
|
0.00%
0/49
|
|
General disorders
DEATH
|
0.99%
1/101
|
0.00%
0/49
|
|
General disorders
PYREXIA
|
5.0%
5/101
|
0.00%
0/49
|
|
General disorders
CHEST DISCOMFORT
|
0.99%
1/101
|
0.00%
0/49
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.99%
1/101
|
0.00%
0/49
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER STAGE 0
|
0.99%
1/101
|
0.00%
0/49
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA
|
0.99%
1/101
|
0.00%
0/49
|
Other adverse events
| Measure |
DASATINIB
n=101 participants at risk
Dasatinib 70 mg twice a day (BID)
|
IMATINIB
n=49 participants at risk
Imatinib 400 mg BID
|
|---|---|---|
|
Eye disorders
EYE OEDEMA
|
0.99%
1/101
|
6.1%
3/49
|
|
Eye disorders
EYELID OEDEMA
|
3.0%
3/101
|
8.2%
4/49
|
|
Eye disorders
CONJUNCTIVITIS
|
5.9%
6/101
|
4.1%
2/49
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
5.9%
6/101
|
0.00%
0/49
|
|
Investigations
WEIGHT DECREASED
|
26.7%
27/101
|
8.2%
4/49
|
|
Investigations
WEIGHT INCREASED
|
13.9%
14/101
|
16.3%
8/49
|
|
Vascular disorders
HYPERTENSION
|
8.9%
9/101
|
0.00%
0/49
|
|
Psychiatric disorders
INSOMNIA
|
8.9%
9/101
|
6.1%
3/49
|
|
Nervous system disorders
HEADACHE
|
45.5%
46/101
|
12.2%
6/49
|
|
Nervous system disorders
DIZZINESS
|
17.8%
18/101
|
6.1%
3/49
|
|
Gastrointestinal disorders
NAUSEA
|
31.7%
32/101
|
38.8%
19/49
|
|
Gastrointestinal disorders
VOMITING
|
17.8%
18/101
|
26.5%
13/49
|
|
Gastrointestinal disorders
DIARRHOEA
|
47.5%
48/101
|
28.6%
14/49
|
|
Gastrointestinal disorders
DYSPEPSIA
|
11.9%
12/101
|
8.2%
4/49
|
|
Gastrointestinal disorders
GASTRITIS
|
8.9%
9/101
|
2.0%
1/49
|
|
Gastrointestinal disorders
TOOTHACHE
|
8.9%
9/101
|
2.0%
1/49
|
|
Gastrointestinal disorders
STOMATITIS
|
5.9%
6/101
|
4.1%
2/49
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.9%
9/101
|
2.0%
1/49
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
15.8%
16/101
|
10.2%
5/49
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
6.9%
7/101
|
0.00%
0/49
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
14.9%
15/101
|
0.00%
0/49
|
|
Infections and infestations
RHINITIS
|
8.9%
9/101
|
0.00%
0/49
|
|
Infections and infestations
PNEUMONIA
|
6.9%
7/101
|
0.00%
0/49
|
|
Infections and infestations
SINUSITIS
|
6.9%
7/101
|
2.0%
1/49
|
|
Infections and infestations
BRONCHITIS
|
9.9%
10/101
|
4.1%
2/49
|
|
Infections and infestations
ORAL HERPES
|
7.9%
8/101
|
4.1%
2/49
|
|
Infections and infestations
PHARYNGITIS
|
8.9%
9/101
|
2.0%
1/49
|
|
Infections and infestations
GASTROENTERITIS
|
7.9%
8/101
|
0.00%
0/49
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.9%
12/101
|
4.1%
2/49
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.9%
6/101
|
2.0%
1/49
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
17.8%
18/101
|
14.3%
7/49
|
|
Metabolism and nutrition disorders
ANOREXIA
|
22.8%
23/101
|
8.2%
4/49
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/101
|
6.1%
3/49
|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.9%
8/101
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.0%
2/101
|
6.1%
3/49
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
21.8%
22/101
|
16.3%
8/49
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
21.8%
22/101
|
10.2%
5/49
|
|
Skin and subcutaneous tissue disorders
RASH
|
29.7%
30/101
|
18.4%
9/49
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
10.9%
11/101
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.9%
12/101
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
5.9%
6/101
|
4.1%
2/49
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
2.0%
2/101
|
6.1%
3/49
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL OEDEMA
|
3.0%
3/101
|
8.2%
4/49
|
|
Reproductive system and breast disorders
BREAST PAIN
|
6.9%
7/101
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
CONTUSION
|
6.9%
7/101
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.9%
13/101
|
10.2%
5/49
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
15.8%
16/101
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
12.9%
13/101
|
6.1%
3/49
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.8%
17/101
|
16.3%
8/49
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
4.0%
4/101
|
16.3%
8/49
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
19.8%
20/101
|
12.2%
6/49
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
11.9%
12/101
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
28.7%
29/101
|
8.2%
4/49
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
24.8%
25/101
|
4.1%
2/49
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.99%
1/101
|
6.1%
3/49
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
21.8%
22/101
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
11.9%
12/101
|
4.1%
2/49
|
|
General disorders
PAIN
|
5.0%
5/101
|
6.1%
3/49
|
|
General disorders
CHILLS
|
5.9%
6/101
|
8.2%
4/49
|
|
General disorders
FATIGUE
|
45.5%
46/101
|
24.5%
12/49
|
|
General disorders
PYREXIA
|
31.7%
32/101
|
16.3%
8/49
|
|
General disorders
ASTHENIA
|
18.8%
19/101
|
6.1%
3/49
|
|
General disorders
CHEST PAIN
|
7.9%
8/101
|
0.00%
0/49
|
|
General disorders
FACE OEDEMA
|
5.9%
6/101
|
14.3%
7/49
|
|
General disorders
FEELING COLD
|
3.0%
3/101
|
6.1%
3/49
|
|
General disorders
OEDEMA PERIPHERAL
|
17.8%
18/101
|
20.4%
10/49
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
9.9%
10/101
|
4.1%
2/49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER