{"eventGroups":[{"deathsNumAffected":6,"deathsNumAtRisk":7,"description":"35mg/m\\^2/dose BID PO Dasatinib x 17 days\n\nIphosfamide, Carboplatin, Etoposide\n\nmicroarray analysis\n\nwestern blotting\n\nimmunohistochemistry staining method\n\nlaboratory biomarker analysis\n\ntherapeutic conventional surgery\n\nradiation therapy","id":"EG000","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":6,"seriousNumAtRisk":7,"title":"Period 1: 35 mg/m^2 Dasatinib BID PO"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Allergic reaction/hypersnsitivity (including drug fever)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Supraventricular and nodal arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Vasovagal episode"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Pericardial effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"INR (International Normalized Ratio of prothrombin time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"PTT (Partial Thromboplastin Time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Fever (absent of neutropenia, ANC<1.0E9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Sweating (diaphoresis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Bruising (in abscence of Grade 3 or 4 thrombocytopenia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Blue Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Contact Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Pale"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Blue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Skin Irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Dry Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Hair loss/alopecia (scalp or body)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Injection site reaction/extravasation changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Pruritus/itching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Distension/bloating, abdominal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Gastritis (including bile reflux gastritis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Heartburn/dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Mucositis/stomatitis (clinical exam)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Mucositis/stomatitis (functional/symptomatic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Salivary gland changes/saliva"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Hemorrhage, GI"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Hemorrhage, GU"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Hemorrhage, pulmonary/upper respiratory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Hemorrhage/Bleeding -- Other, Conjunctival"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Hemorrhage/Bleeding -- Other, Scleral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Febrile neutropenia ANC<1E9/L (fever of unknown origin without documented infection)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Infection with Gr 3 or 4 neutrophils (ANC<1E9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophil"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Edema: head and neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Edema: limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Edema: trunk/genital"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"AST, SGOT(serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Acidosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Alkalosis metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Bicarbonate, serum-low"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Calcium, serum-high (hypercalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Calcium, serum-low (hypocalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Cholesterol, serum-high (hypercholesteremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Glucose, serum-low (hypoglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Magnesium, serum-high (hypermagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Magnesium, serum-low (hypomagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Metabolic/Laboratory -- Other: Hematochromatomatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Sodium, serum-high (hypernatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Triglyceride, serum-high (hypertriglyceridemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Muscle weakness, not due to neuropathy, Extremity Lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Muscle weakness, not due to neuropathy, Extremity Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Muscular/skeletal hypoplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Musculoskeletal/Soft Tissue, Other: Atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Musculoskeletal/Soft Tissue, Other: Avulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Musculoskeletal/Soft Tissue, Other: Osteopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Osteoporosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Ataxia (incoordination)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Memory Impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7}],"term":"Mood alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Mood alteration, depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Personality/behavioral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Psychosis (hallucinations/delusions)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Somnolescence/depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Speech impairment (e.g., dysphasia or aphasia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Syncope (fainting)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Dry eye syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Ocular/visual, other: Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":7}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Pain, other: Cathetar related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Adult Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Bronchospasm, wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Nasal cavity/paranasal sinus reactions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Pulmonary/Upper Respiratory, Other: Phrenic Nerve Cut"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Bladder spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Incontinence, urinary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Urinary retention (including neurogenic bladder)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Urine color change"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7}],"term":"Petechiae/purpura (hemorrhage/bleeding into the skin or mucosa)"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 5 Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils(ANC\\<1.0 x 10e9/L) -- Brain (encephalitis, infections) Possibly, probably, or definitely attributable to the study regimen.","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7}],"term":"Infection -- Brain (encephalitis, infections)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Attribution is: Unlikely or unrelated to the study regimen.","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7}],"term":"Death not associated with CTCAE term -- Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Attributed is: Unlikely or unrelated to the study regimen.","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7}],"term":"Death not associated with CTCAE term -- Disease progression, NOS"}],"timeFrame":"Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study."}