{"description":"All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.","eventGroups":[{"description":"Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":39,"otherNumAtRisk":40,"seriousNumAffected":12,"seriousNumAtRisk":40,"title":"Adenoid Cystic Carcinoma"},{"description":"Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":13,"otherNumAtRisk":14,"seriousNumAffected":8,"seriousNumAtRisk":14,"title":"Non Adenoid Cystic Carcinoma"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Abdominal distension"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Activated partial thromboplastin time prolonged"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Alanine aminotransferase increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Alkaline phosphatase increased"},{"organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Allergic reaction"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Allergic rhinitis"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Alopecia"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":14}],"term":"Anemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Anorexia"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Anxiety"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Arthralgia"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":14}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Aspiration"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Back pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Bronchopulmonary hemorrhage"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"CD4 lymphocytes decreased"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Chest wall pain"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Chills"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Constipation"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":14}],"term":"Cough"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Creatinine increased"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dehydration"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Depression"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":40},{"groupId":"EG001","numAffected":6,"numAtRisk":14}],"term":"Diarrhea"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Dizziness"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dry mouth"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dry skin"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Dysgeusia"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Dyspepsia"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dysphagia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40},{"groupId":"EG001","numAffected":6,"numAtRisk":14}],"term":"Dyspnea"},{"organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Ear pain"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Edema face"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Edema limbs"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Epistaxis"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Eructation"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Facial pain"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":40},{"groupId":"EG001","numAffected":9,"numAtRisk":14}],"term":"Fatigue"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Fever"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Flu like symptoms"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Gastroesophageal reflux disease"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Generalized muscle weakness"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Headache"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Hoarseness"},{"organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Hot flashes"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Hyperkalemia"},{"organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Hypertension"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Hypoalbuminemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Hyponatremia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Hypophosphatemia"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"INR increased"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Infections and infestations"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Insomnia"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Libido decreased"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Lung infection"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Lymph node pain"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Lymphocyte count decreased"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Myalgia"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":40},{"groupId":"EG001","numAffected":8,"numAtRisk":14}],"term":"Nausea"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Neutrophil count decreased"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Nipple sensitivity"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Non-cardiac chest pain"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Oral pain"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Pain in extremity"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Palpitations"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Peripheral motor neuropathy"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Peripheral sensory neuropathy"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Platelet count decreased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Pleural effusion"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Pruritus"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Rash acneiform"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Rash maculo-papular"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Rectal hemorrhage"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Skin erosion"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Somnolence"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Stomach pain"},{"organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Urinary tract pain"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Vomiting"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Weight loss"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Wheezing"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"White blood cell decreased"}],"seriousEvents":[{"organSystem":"Investigations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Alanine aminotransferase increased"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Anorexia"},{"organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Cauda equina syndrome"},{"organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Chest pain"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Confusion"},{"organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Death"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dysphagia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dyspnea"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Hyperglycemia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Hypoxia"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Infections and infestations"},{"organSystem":"Eye disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Loss of vision"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Nausea"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Non-cardiac chest pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Pleural effusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Pneumonitis"},{"organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Thromboembolic event"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (8.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Urticaria"}],"timeFrame":"Up to 5 years"}