{"eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":48,"description":"Questionnaire Administration: Ancillary studies","id":"EG000","otherNumAffected":48,"otherNumAtRisk":48,"seriousNumAffected":16,"seriousNumAtRisk":48,"title":"Phase I/II, Cohort A"},{"deathsNumAffected":7,"deathsNumAtRisk":35,"description":"Questionnaire Administration: Ancillary studies","id":"EG001","otherNumAffected":35,"otherNumAtRisk":35,"seriousNumAffected":15,"seriousNumAtRisk":35,"title":"Phase II, Cohort B"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":48,"numEvents":29},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":3}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":2}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":48,"numEvents":179},{"groupId":"EG001","numAffected":25,"numAtRisk":35,"numEvents":68}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":48,"numEvents":115},{"groupId":"EG001","numAffected":15,"numAtRisk":35,"numEvents":48}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Gastrointestinal disorders - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":48,"numEvents":138},{"groupId":"EG001","numAffected":22,"numAtRisk":35,"numEvents":66}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":48,"numEvents":17},{"groupId":"EG001","numAffected":6,"numAtRisk":35,"numEvents":11}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":35,"numEvents":10}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Edema trunk"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":48,"numEvents":546},{"groupId":"EG001","numAffected":32,"numAtRisk":35,"numEvents":221}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Infections and infestations - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":5}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"CD4 lymphocytes decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":48,"numEvents":25},{"groupId":"EG001","numAffected":15,"numAtRisk":35,"numEvents":138}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":48,"numEvents":296},{"groupId":"EG001","numAffected":9,"numAtRisk":35,"numEvents":40}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"Lymphocyte count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":48,"numEvents":138},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":3}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":48,"numEvents":86},{"groupId":"EG001","numAffected":11,"numAtRisk":35,"numEvents":25}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":48,"numEvents":230},{"groupId":"EG001","numAffected":6,"numAtRisk":35,"numEvents":8}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":48,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":3}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":3}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Musculoskeletal, conn tissue - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Neoplasms benign, mal, uncpec - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":48,"numEvents":24},{"groupId":"EG001","numAffected":3,"numAtRisk":35,"numEvents":4}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":48,"numEvents":361},{"groupId":"EG001","numAffected":19,"numAtRisk":35,"numEvents":91}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":48,"numEvents":10},{"groupId":"EG001","numAffected":8,"numAtRisk":35,"numEvents":18}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Libido decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":35,"numEvents":10}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":7}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":2}],"term":"Voice alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":48,"numEvents":34},{"groupId":"EG001","numAffected":11,"numAtRisk":35,"numEvents":70}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":12},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":7}],"term":"Thromboembolic event"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Gastric hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Infections and infestations - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Neoplasms benign, mal, uncpec - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Bronchial obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":3}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Resp, thoracic, mediastinal - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Hypotension"}],"timeFrame":"5 years"}