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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003624-37 |
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This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib, 50 mg QD to 120 mg BID, Chronic phase | Other | Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). |
|
| Imatinib, 400 mg BID, Chronic phase | Other | Participants with chronic phase disease received 400 mg of imatinib twice BID. |
|
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP | Other | Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. |
|
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP | Other | Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. |
|
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL | Other | Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Dasatinib was supplied as 20- and 50-mg tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. 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. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug. | Day 1 of treatment through a maximum of 82 months + 30 days |
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Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Medical Center Inc | Anaheim | California | 92801 | United States | ||
| Loma Linda University Cancer Center |
A total of 238 patients were enrolled: 200 with chronic phase chronic myelogenous leukemia (CML) and 38 with advanced phase disease (34 with acclelerated phase CML, 3 with myeloid blast phase CML, and 1 with Philadelphia chromosome positive acute lymphoblastic leukemia.) All but 1 CML patient, who no longer met study criteria, received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib 50 mg QD to 120 mg BID, Chronic Phase | Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Imatinib | Drug | Imatinib was supplied as 100- and 400-mg tablets. |
|
|
| Loma Linda |
| California |
| 92354 |
| United States |
| Ucla Department Of Medicine | Los Angeles | California | 90095 | United States |
| Stanford University School Of Medicine | Stanford | California | 94305 | United States |
| Kaiser Permanente Medical Center | Vallejo | California | 94589 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| University Of Chicago | Chicago | Illinois | 60637 | United States |
| Central Indiana Cancer Centers | Indianapolis | Indiana | 46219 | United States |
| University Of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| Dana Faber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University Of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Oregon Health & Sci Univ | Portland | Oregon | 97239 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Ut Southwestern Medical Center At Dallas | Dallas | Texas | 75390 | United States |
| The University Of Texas Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1021 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 1280 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1425 | Argentina |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Mont-godinne | 5530 | Belgium |
| Local Institution | Curitiba | Paraná | 80060 | Brazil |
| Local Institution | Rio de Janeiro | Rio de Janeiro | 20231 | Brazil |
| Local Institution | Campinas | São Paulo | 13083 | Brazil |
| Local Institution | São Paulo | São Paulo | 05403 | Brazil |
| Local Institution | São Paulo | São Paulo | 05652 | Brazil |
| Local Institution | Toronto | Ontario | M4X 1K9 | Canada |
| Local Institution | Montreal | Quebec | H3A 1A1 | Canada |
| Local Institution | Helsinki | 00029 | Finland |
| Local Institution | Lille | 59000 | France |
| Local Institution | Lyon | 69437 | France |
| Local Institution | Nantes | 44035 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Poitiers | 86021 | France |
| Local Institution | Strasbourg | 67091 | France |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Leipzig | 04103 | Germany |
| Local Institution | Mannheim | 68167 | Germany |
| Local Institution | Budapest | 1097 | Hungary |
| Local Institution | Dublin | Dublin | Ireland |
| Local Institution | Ramat Gan | 52621 | Israel |
| Local Institution | Bologna | 40138 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Orbassano (to) | 10043 | Italy |
| Local Institution | Roma | 00144 | Italy |
| Local Institution | Trondheim | 7006 | Norway |
| Local Institution | Lima | Lima Province | 34 | Peru |
| Local Institution | Lima | Lima Province | LIMA II | Peru |
| Local Institution | Katowice | 40032 | Poland |
| Local Institution | Krakow | 31501 | Poland |
| Local Institution | Lodz | 93-510 | Poland |
| Local Institution | Lublin | 20081 | Poland |
| Local Institution | Warsaw | 02097 | Poland |
| Local Institution | Moscow | 125167 | Russia |
| Local Institution | Saint Petersburg | 179089 | Russia |
| Local Institution | Groenkloof | Gauteng | 0181 | South Africa |
| Local Institution | Parktown | Gauteng | 2193 | South Africa |
| Local Institution | Jeollanam-do | 519-809 | South Korea |
| Local Institution | Seoul | 137-040 | South Korea |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Gothenburg | 41345 | Sweden |
| Local Institution | Lund | 221 85 | Sweden |
| Local Institution | Stockholm | SE-17176 | Sweden |
| Local Institution | Umeå | 901 85 | Sweden |
| Local Institution | Uppsala | 751 85 | Sweden |
| Local Institution | Basel | 4031 | Switzerland |
| Local Institution | Bangkok | 10400 | Thailand |
| Local Institution | London | Greater London | W12 OHS | United Kingdom |
| Local Institution | Glasgow | Scotland | G12 OXB | United Kingdom |
| Local Institution | Newcastle | Tyne and Wear | NE2 4HH | United Kingdom |
| FG001 | Imatinib, 400 mg BID, Chronic Phase | Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| FG002 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| FG003 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB | Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| FG004 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL | Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib 50 mg QD to 120 mg BID, Chronic Phase | Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| BG001 | Imatinib, 400 mg BID, Chronic Phase | Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| BG002 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| BG003 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB | Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| BG004 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL | Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. 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. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | Day 1 of treatment through a maximum of 82 months + 30 days |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. | 57 | 185 | 138 | 185 | ||
| EG001 | Imatinib, 400 mg BID, Chronic Phase | Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. | 3 | 14 | 10 | 14 | ||
| EG002 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. | 15 | 34 | 24 | 34 | ||
| EG003 | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. | 1 | 3 | 2 | 3 | ||
| EG004 | Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL | Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure. | 1 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oophorectomy bilateral | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Effusion | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Elderly | Social circumstances | MedDRA 17.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasal septum perforation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diastolic dysfunction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nodal arrhythmia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Blood bilirubin | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D019061 | src-Family Kinases |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
Not provided
Not provided
| 21-45 years |
|
| 46-65 years |
|
| 66-75 years |
|
| Older than 75 years |
|
| Male |
|
| Black/African American |
|
| Asian |
|
| Other |
|
| Deaths within 30 days of last dose |
|
| SAEs |
|
| Drug-related SAEs |
|
| AEs leading to discontinuation |
|
| Drug-related AEs leading to discontinuation |
|
| Drug-related AEs |
|
| Drug-related AEs of special interest |
|