Trial Outcomes & Findings for Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib (NCT NCT01660906)

Last Updated: 2016-11-22

Results Overview

Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

3 months after switch to dasatinib

Results posted on

2016-11-22

Participant Flow

39 participants enrolled and were treated.

Participant milestones

Participant milestones
Measure	Dasatinib (100 mg) Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib (100 mg) Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Overall Study Discontinued due to study drug toxicity	3

Baseline Characteristics

Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Age, Continuous	55.1 years STANDARD_DEVIATION 15.13 • n=5 Participants
Age, Customized < 65 years	27 Participants n=5 Participants
Age, Customized >= 65 years	12 Participants n=5 Participants
Gender Female	18 Participants n=5 Participants
Gender Male	21 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	22 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants
Median Time Since CML-CP Diagnosis	51.3 months n=5 Participants
Median Duration of Imatinib Treatment	51.2 months n=5 Participants
Imatinib Dose at Baseline < 400 milligrams	19 Participants n=5 Participants
Imatinib Dose at Baseline 400 milligrams	20 Participants n=5 Participants
Best Baseline Response MR4.5	10 Participants n=5 Participants
Best Baseline Response MMR	20 Participants n=5 Participants
Best Baseline Response CCyR	4 Participants n=5 Participants
Best Baseline Response PCyR	2 Participants n=5 Participants
Best Baseline Response Cytogenetic Test Not Performed	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after switch to dasatinib

Population: All treated participants.

Outcome measures

Outcome measures
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment Resolved	91 adverse event(s)
The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment Improved	2 adverse event(s)
The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment Unchanged	27 adverse event(s)
The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment Worsened	1 adverse event(s)

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12 months

Population: All treated participants.

The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely.

Outcome measures

Outcome measures
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Core Symptom Severity Score, Month 3; n=37	-1.35 units on a scale Standard Deviation 1.78
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Core Symptom Severity Score, Month 6; n=36	-1.44 units on a scale Standard Deviation 1.84
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Core Symptom Severity Score, Month 12; n=37	-1.06 units on a scale Standard Deviation 1.87
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Interference Score, Month 3; n=37	-1.24 units on a scale Standard Deviation 2.36
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Interference Score, Month 6; n=35	-1.28 units on a scale Standard Deviation 2.45
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Interference Score, Month 12; n=36	-1.30 units on a scale Standard Deviation 2.56
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Symptom Severity Score, Month 3; n=37	-1.73 units on a scale Standard Deviation 1.80
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Symptom Severity Score, Month 6; n=36	-1.80 units on a scale Standard Deviation 1.85
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib Symptom Severity Score, Month 12; n=37	-1.46 units on a scale Standard Deviation 1.75
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib CML-specific Symptom Severity Score, Month 3; n=37	-2.52 units on a scale Standard Deviation 2.35
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib CML-specific Symptom Severity Score, Month 6; n=36	-2.60 units on a scale Standard Deviation 2.15
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib CML-specific Symptom Severity Score,Month 12; n=36	-2.24 units on a scale Standard Deviation 1.87
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib 5 Most Severe Symptom Score, Month 3; n=37	-1.61 units on a scale Standard Deviation 1.76
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib 5 Most Severe Symptom Score, Month 6; n=36	-1.69 units on a scale Standard Deviation 1.84
Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib 5 Most Severe Symptom Score, Month 12; n=37	-1.43 units on a scale Standard Deviation 1.72

SECONDARY outcome

Timeframe: Baseline to 6, 12 months

Population: All treated participants

The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology.

Outcome measures

Outcome measures
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Global Health Status/QOL, Month 6; n=36	0.46 units on a scale Standard Deviation 23.733
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Global Health Status/QOL, Month 12; n=35	2.86 units on a scale Standard Deviation 27.782
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Cognitive Functioning, Month 6; n=35	1.90 units on a scale Standard Deviation 20.119
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Cognitive Functioning, Month 12; n=35	1.43 units on a scale Standard Deviation 18.245
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Emotional Functioning, Month 6; n=35	11.19 units on a scale Standard Deviation 23.216
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Emotional Functioning, Month 12; n=35	12.62 units on a scale Standard Deviation 25.595
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Physical Functioning, Month 6; n=36	-1.67 units on a scale Standard Deviation 20.923
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Physical Functioning, Month 12; n=36	0.74 units on a scale Standard Deviation 19.241
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Role Functioning, Month 6; n=36	-4.17 units on a scale Standard Deviation 27.422
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Role Functioning, Month 12; n=36	2.78 units on a scale Standard Deviation 23.401
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Social Functioning, Month 6; n=35	13.81 units on a scale Standard Deviation 26.036
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Social Functioning, Month 12; n=35	14.76 units on a scale Standard Deviation 24.512
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Fatigue, Month 6; n=36	-6.79 units on a scale Standard Deviation 20.102
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Fatigue, Month 12; n=36	-8.33 units on a scale Standard Deviation 21.639
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Nausea and Vomiting, Month 6; n=36	-9.72 units on a scale Standard Deviation 31.966
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Nausea and Vomiting, Month 12; n=36	-4.63 units on a scale Standard Deviation 30.760
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Pain, Month 6; n=36	-2.78 units on a scale Standard Deviation 38.318
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Pain, Month 12; n=36	-8.80 units on a scale Standard Deviation 25.350
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Appetite Loss, Month 6; n=35	1.90 units on a scale Standard Deviation 29.085
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Appetite Loss, Month 12; n=36	1.85 units on a scale Standard Deviation 29.755
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Constipation, Month 6; n=36	-0.93 units on a scale Standard Deviation 28.156
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Constipation, Month 12; n=35	8.57 units on a scale Standard Deviation 23.351
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Diarrhoea, Month 6; n=36	0.00 units on a scale Standard Deviation 36.515
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Diarrhoea, Month 12; n=35	-2.86 units on a scale Standard Deviation 40.722
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Dyspnoea, Month 6; n=36	5.56 units on a scale Standard Deviation 36.947
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Dyspnoea, Month 12; n=36	9.26 units on a scale Standard Deviation 39.530
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Financial Difficulties, Month 6; n=35	-10.48 units on a scale Standard Deviation 21.038
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Financial Difficulties, Month 12; n=35	-13.33 units on a scale Standard Deviation 18.436
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Insomnia, Month 6; n=36	0.93 units on a scale Standard Deviation 42.528
Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib Insomnia, Month 12; n=36	-1.85 units on a scale Standard Deviation 38.991

SECONDARY outcome

Timeframe: Date of first dose to 30 post last dose of study drug, an average of 3 years

Population: All treated participants.

SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib.

Outcome measures

Outcome measures
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome At least 1 AE	37 Participants
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome Discontinuation due to AE	3 Participants
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome Treatment-related AEs	34 Participants
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome SAEs	11 Participants
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome Treatment-related SAEs	3 Participants
Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome Death	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: All treated participants.

Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib	87.1 percentage of participants Interval 72.5 to 95.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 12 months

Population: All treated participants.

Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline.

Outcome measures

Outcome measures
Measure	Dasatinib (100 mg) n=39 Participants Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib MMR, Month 6	13 Participants
Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib MMR, Month 12	13 Participants
Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib MR4.5, Month 6	18 Participants
Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib MR4.5, Month 12	22 Participants

Adverse Events

Dasatinib

Serious events: 11 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=39 participants at risk Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Haemorrhoids	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Infections and infestations Pneumonia	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Infections and infestations Appendicitis	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Anal fissure	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Injury, poisoning and procedural complications Rib fracture	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
General disorders Pyrexia	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Infections and infestations Upper respiratory tract infection	2.6% 1/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015

Other adverse events

Other adverse events
Measure	Dasatinib n=39 participants at risk Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Gastrooesophageal reflux disease	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Cardiac disorders Left ventricular hypertrophy	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.6% 10/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Blood and lymphatic system disorders Anaemia	12.8% 5/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
General disorders Asthenia	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
General disorders General physical health deterioration	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Nervous system disorders Headache	38.5% 15/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Investigations Blood urea increased	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Nervous system disorders Dizziness	10.3% 4/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Musculoskeletal and connective tissue disorders Myalgia	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Nausea	20.5% 8/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Vomiting	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.6% 10/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Musculoskeletal and connective tissue disorders Tendonitis	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Investigations Blood creatinine increased	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
General disorders Fatigue	25.6% 10/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Investigations Alanine aminotransferase increased	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Infections and infestations Bronchitis	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Psychiatric disorders Depression	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Skin and subcutaneous tissue disorders Pruritus	10.3% 4/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 6/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Metabolism and nutrition disorders Hyperuricaemia	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Nervous system disorders Paraesthesia	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Cardiac disorders Pericardial effusion	7.7% 3/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Constipation	10.3% 4/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Cough	15.4% 6/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Gastrointestinal disorders Diarrhoea	28.2% 11/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
General disorders Face oedema	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
General disorders Pyrexia	15.4% 6/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Skin and subcutaneous tissue disorders Rash	25.6% 10/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.1% 2/39 • Date of fist dose of study drug to 30 days post discontinuation of the last dose, an average of 3 years Study initiated: December 2012; Study Completion: October 2015

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

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