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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01317 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-2010-00440 | |||
| 2005-0422 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control CML in chronic phase. The safety of this drug will also be studied.
Dasatinib is an anticancer drug that is designed to block the function of BCR-ABL, which is the abnormal protein responsible for causing leukemia in certain cells.
Before you can start therapy on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (about 2 tablespoons) will be collected for routine tests. You will also have a bone marrow biopsy and aspiration. To collect a bone marrow biopsy and aspiration, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test. If you are found to be eligible to take part in this study and you agree, you will take dasatinib once every day while on study. Dasatinib should be taken by mouth with water.
Every 1-2 weeks during the first 4 weeks of the study, you will have around 2 tablespoons of blood drawn for routine blood tests. The blood tests will be repeated every 4-6 weeks until 1 year from when you started therapy and then every 3-4 months until 2 years, then as often as the doctor thinks it is needed. A bone marrow aspiration will also be taken to check the status of the disease every 3-4 months for the first year and then as often as the doctor thinks it is needed for as long as you are on the study.
You will be given a medication diary to monitor any missed doses. You will also be asked to visit the doctor for a physical exam and to have vital signs measured periodically. These visits will be scheduled at least every 3-4 months for the first year, then recommended every 6 to 12 months while you are on the study. The visits may be scheduled more often depending on the status of the disease.
Treatment may be continued for up to 8-10 years or as long as the doctor feels it is necessary to control the leukemia. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. If you decide to stop participating in the study, you are encouraged to discuss your decision with your study doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib | Experimental | Patients receive dasatinib PO QD for up to 15-18 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Major Molecular Response at 12 Months | Major Molecular Response (MMR) is BCR-ABL/ABL ratio \ | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from date of treatment start until date of death due to any cause or last Follow-up. | Up to 19 years, 4 months and 6 days |
| Participants With Complete Cytogenic Response (CCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia Masarova, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30885996 | Derived | Jain P, Kantarjian H, Boddu PC, Nogueras-Gonzalez GM, Verstovsek S, Garcia-Manero G, Borthakur G, Sasaki K, Kadia TM, Sam P, Ahaneku H, O'Brien S, Estrov Z, Ravandi F, Jabbour E, Cortes JE. Analysis of cardiovascular and arteriothrombotic adverse events in chronic-phase CML patients after frontline TKIs. Blood Adv. 2019 Mar 26;3(6):851-861. doi: 10.1182/bloodadvances.2018025874. | |
| 28835440 |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib | Patients receive dasatinib PO QD for up to 15-18 years. Dasatinib: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2019 |
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Complete Cytogenic Response (CCR) is Ph positive 0%
| Up to 19 years, 4 months and 6 days |
| Participants Who Developed the ABL Mutations | ABL mutations will be assesses during treatment through Quanitiative PCR (qPCR) (RT-qPCR) or ABM mutational analysis using Sanger Sequencing or next-Generation Sequencing (NGS). | Up to 19 years, 4 months and 6 days |
| Derived |
| Issa GC, Kantarjian HM, Gonzalez GN, Borthakur G, Tang G, Wierda W, Sasaki K, Short NJ, Ravandi F, Kadia T, Patel K, Luthra R, Ferrajoli A, Garcia-Manero G, Rios MB, Dellasala S, Jabbour E, Cortes JE. Clonal chromosomal abnormalities appearing in Philadelphia chromosome-negative metaphases during CML treatment. Blood. 2017 Nov 9;130(19):2084-2091. doi: 10.1182/blood-2017-07-792143. Epub 2017 Aug 23. |
| 23620574 | Derived | Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib | Patients receive dasatinib PO QD for up to 15-18 years. Dasatinib: Given PO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | 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 With a Major Molecular Response at 12 Months | Major Molecular Response (MMR) is BCR-ABL/ABL ratio \ | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from date of treatment start until date of death due to any cause or last Follow-up. | Posted | Median | Full Range | Months | Up to 19 years, 4 months and 6 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Participants With Complete Cytogenic Response (CCR) | Complete Cytogenic Response (CCR) is Ph positive 0% | Posted | Count of Participants | Participants | Up to 19 years, 4 months and 6 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Participants Who Developed the ABL Mutations | ABL mutations will be assesses during treatment through Quanitiative PCR (qPCR) (RT-qPCR) or ABM mutational analysis using Sanger Sequencing or next-Generation Sequencing (NGS). | Posted | Count of Participants | Participants | Up to 19 years, 4 months and 6 days |
|
|
Up to 19 years, 4 months and 6 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib | Patients receive dasatinib PO QD for up to 15-18 years. Dasatinib: Given PO | 4 | 150 | 34 | 150 | 144 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergy-Other : Angioedema/allergic reaction to Enalapril | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergy-Other : Study drug (Dasatinib) overdose | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Biventricular Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac Pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Congestive Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Left distal biceps tendon repair | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| monoclonal gammopathy of undetermined significance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neurology/Potential Drug Dependency | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Prolonged QTc | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Squamous Cell Carcinoma of the skin -back of left ear | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Squamous Cell Carcinoma of the Right Ear | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| unexpected pregnancy | Pregnancy, puerperium and perinatal conditions | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACNE | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALKALINE PHOSPHATASE | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALLERGY/IMMUNOLOGY (OTHER) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALT SGPT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| AST SGOT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| AUDITORY/EAR (OTHER) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| BILIRUBIN | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| BLURRED VISION | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CARDIAC ARRHYTHMIA (OTHER) | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CARDIAC GENERAL (OTHER) | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CHOLESTEROL | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CONSTITUTIONAL SYMPTOMS (OTHER) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CREATININE | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| DERMATOLOGY/SKIN (OTHER) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| EDEMA | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| EDEMA: HEAD AND NECK | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| EDEMA: LIMB | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| FEVER WITHOUT NEUTROPENIA | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GASTROINTESTINAL (OTHER) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HEMOGLOBIN | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPERURICEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION (OTHER) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION UNKNOWN ANC (SINUS) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION W NORMAL ANC (LUNG - PNEUMONIA) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION W NORMAL ANC (SINUS) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION W NORMAL ANC (URINARY TRACT NOS) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INFECTION WITHOUT NEUTROPENIA | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MENTAL STATUS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| METABOLIC/LABORATORY (OTHER) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MOOD ALTERATION (ANXIETY) | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MOOD ALTERATION (DEPRESSION) | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL (OTHER) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| NEUROLOGY (OTHER) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| NEUROPATHY: MOTOR | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| NEUROPATHY: SENSORY | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| NEUTROPHILS (ANC/AGC) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| OCULAR VISUAL (OTHER) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (ABDOMEN NOS) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (BACK) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (BONE) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (CHEST/THORAX) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (EXTREMITY-LIMB) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (HEAD/HEADACHE) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (JOINT) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (MUSCLE) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (ORAL CAVITY) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (OTHER) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PAIN (THROAT/PHARYNX/LARYNX) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PERIORBITAL EDEMA | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PLATELETS | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PULMONARY (OTHER) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| RENAL/GENITOURINARY (OTHER) | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| RIGORS/CHILLS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| SEXUAL/REPRODUCTIVE (OTHER) | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| SINUS BRADYCARDIA | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| SWEATING | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ULCERATION | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| WATERY EYE | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| WATERY EYES | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| WEIGHT GAIN | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucia Masarova MD/Associate Professor | The University of Texas MD Anderson Cancer Center | 832-750-4211 | LMasarova@mdanderson.org |
| Nov 4, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2020 | Mar 19, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Title | Denominators | Categories |
|---|
|