{"eventGroups":[{"description":"After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \\> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)","id":"EG000","otherNumAffected":134,"otherNumAtRisk":153,"seriousNumAffected":51,"seriousNumAtRisk":153,"title":"Vatalanib"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Blood disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":153,"numEvents":12}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":121,"numAtRisk":153,"numEvents":324}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Spleen disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Transfusion: pRBCs for pediatric BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Cardiac disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Conduction disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Left ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Myocardial ischemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":6}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"External ear inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":3}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Endocrine disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Eye disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Flashing vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Anal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":153,"numEvents":28}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":153,"numEvents":71}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":9}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":8}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Esophageal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Gastric hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":8}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":153,"numEvents":135}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Oral hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Proctitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Rectal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Stomach pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":153,"numEvents":70}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":8}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":153,"numEvents":21}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":116,"numAtRisk":153,"numEvents":233}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":153,"numEvents":16}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Gait abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":153,"numEvents":13}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Visceral edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Immune system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Duodenal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Esophageal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":5}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Infection with grade 3 or 4 neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Infection without neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Opportunistic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Rhinitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":5}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":7}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":6}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":153,"numEvents":41}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":153,"numEvents":18}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":153,"numEvents":36}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":12}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Coagulopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":153,"numEvents":14}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Electrocardiogram QTc interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":8}],"term":"Laboratory test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":153,"numEvents":29}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":153,"numEvents":198}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pancreatic enzymes decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":100,"numAtRisk":153,"numEvents":226}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":7}],"term":"Serum cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":153,"numEvents":15}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":153,"numEvents":36}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":153,"numEvents":70}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":153,"numEvents":15}],"term":"Serum albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":153,"numEvents":16}],"term":"Serum calcium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Serum calcium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":5}],"term":"Serum glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Serum magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Serum magnesium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":8}],"term":"Serum potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Serum potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":9}],"term":"Serum sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Serum sodium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":7}],"term":"Serum triglycerides increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":153,"numEvents":16}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":153,"numEvents":14}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":5}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":9}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Muscle weakness upper limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Musculoskeletal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":153,"numEvents":9}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":8}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Myelodysplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":153,"numEvents":17}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":153,"numEvents":82}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Extrapyramidal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":153,"numEvents":22}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":5}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Mini mental status examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Neurological disorder NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":6}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":153,"numEvents":16}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Speech disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Vagus nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":6}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Euphoria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":153,"numEvents":12}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":4}],"term":"Hemorrhage urinary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Kidney pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":153,"numEvents":47}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Urine discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Urogenital disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Scrotal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Vaginal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Vaginal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":6}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":153,"numEvents":27}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":153,"numEvents":51}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":153,"numEvents":18}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Respiratory tract hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":6}],"term":"Voice alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":7}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":7}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":153,"numEvents":25}],"term":"Rash desquamating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":153,"numEvents":9}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":7}],"term":"Sweating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hot flashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":153,"numEvents":15}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Vascular disorder"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":8}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":153,"numEvents":48}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Arrhythmia supraventricular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Colonic hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":153,"numEvents":23}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Duodenal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":6}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Esophageal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":153,"numEvents":33}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Oral hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Rectal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":153,"numEvents":31}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":5}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":6}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":153,"numEvents":41}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":8}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hypothermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Gallbladder pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Duodenal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Gingival infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Infection without neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":153,"numEvents":11}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":7}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":153,"numEvents":13}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Cardiac troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Coagulopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":8}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Electrocardiogram QTc interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Laboratory test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":153,"numEvents":30}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":153,"numEvents":47}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Serum cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":5}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":153,"numEvents":12}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":153,"numEvents":16}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":9}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":153,"numEvents":9}],"term":"Serum albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":153,"numEvents":13}],"term":"Serum calcium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Serum calcium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":4}],"term":"Serum glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":6}],"term":"Serum magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Serum magnesium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Serum phosphate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":8}],"term":"Serum potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Serum potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":9}],"term":"Serum sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Serum sodium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Serum triglycerides increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":2}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Treatment related secondary malignancy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":153,"numEvents":6}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":153,"numEvents":14}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Extrapyramidal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":153,"numEvents":10}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Ischemia cerebrovascular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Neurological disorder NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Speech disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":7}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":3}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Bladder pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":153,"numEvents":4}],"term":"Hemorrhage urinary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":153,"numEvents":12}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":8}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":153,"numEvents":11}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":153,"numEvents":9}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Pharyngeal examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Respiratory tract hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Tracheoscopy abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Voice alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hand-and-foot syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Photosensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Pigmentation changes (e.g., vitiligo)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":153,"numEvents":2}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Rash desquamating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":153,"numEvents":3}],"term":"Sweating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":153,"numEvents":1}],"term":"Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":153,"numEvents":9}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":153,"numEvents":5}],"term":"Hypotension"}]}