{"description":"All reported safety data based upon the Safety Population: all participants who received ≥1 dose of avapritinib regardless of the starting avapritinib dose (N=107). All participants were treated with a starting dose of 200 mg with the exception of 2 participants who were treated with a starting dose of 100 mg.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":2,"description":"Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.","id":"EG000","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":2,"seriousNumAtRisk":2,"title":"Avapritinib (100 mg)"},{"deathsNumAffected":33,"deathsNumAtRisk":105,"description":"Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.","id":"EG001","otherNumAffected":104,"otherNumAtRisk":107,"seriousNumAffected":67,"seriousNumAtRisk":105,"title":"Avapritinib (200 mg)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":54,"numAtRisk":107,"numEvents":203}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":48,"numAtRisk":107,"numEvents":282}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":6},{"groupId":"EG001","numAffected":24,"numAtRisk":107,"numEvents":125}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":4},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":28}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":45,"numAtRisk":107,"numEvents":78}],"term":"Periorbital oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":14,"numAtRisk":107,"numEvents":15}],"term":"Eyelid oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":36,"numAtRisk":107,"numEvents":60}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":29,"numAtRisk":107,"numEvents":36}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":24,"numAtRisk":107,"numEvents":29}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":16,"numAtRisk":107,"numEvents":22}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":16,"numAtRisk":107,"numEvents":20}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":9,"numAtRisk":107,"numEvents":10}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":13}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":107,"numEvents":9}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":48,"numAtRisk":107,"numEvents":72}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":22,"numAtRisk":107,"numEvents":31}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":18,"numAtRisk":107,"numEvents":19}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":13,"numAtRisk":107,"numEvents":27}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":107,"numEvents":9}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":9}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":19,"numAtRisk":107,"numEvents":22}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":3},{"groupId":"EG001","numAffected":13,"numAtRisk":107,"numEvents":30}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":107,"numEvents":8}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":7}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":10,"numAtRisk":107,"numEvents":11}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":17,"numAtRisk":107,"numEvents":22}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":16,"numAtRisk":107,"numEvents":19}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":15,"numAtRisk":107,"numEvents":38}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":15,"numAtRisk":107,"numEvents":29}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":14,"numAtRisk":107,"numEvents":85}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":17,"numAtRisk":107,"numEvents":82}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":12,"numAtRisk":107,"numEvents":57}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":10,"numAtRisk":107,"numEvents":15}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":9,"numAtRisk":107,"numEvents":16}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":8}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":14,"numAtRisk":107,"numEvents":19}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":9,"numAtRisk":107,"numEvents":11}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":13}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":107,"numEvents":10}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":7}],"term":"Folate deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":8}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":27,"numAtRisk":107,"numEvents":44}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":13,"numAtRisk":107,"numEvents":17}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":8}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":19,"numAtRisk":107,"numEvents":31}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":16,"numAtRisk":107,"numEvents":23}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":13,"numAtRisk":107,"numEvents":16}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":10,"numAtRisk":107,"numEvents":13}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":10,"numAtRisk":107,"numEvents":12}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":8}],"term":"Disturbance in attention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":7}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":9,"numAtRisk":107,"numEvents":9}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":8}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":19,"numAtRisk":107,"numEvents":24}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":11,"numAtRisk":107,"numEvents":37}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":107,"numEvents":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":18,"numAtRisk":107,"numEvents":34}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":18,"numAtRisk":107,"numEvents":19}],"term":"Hair colour changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":18,"numAtRisk":107,"numEvents":24}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":12,"numAtRisk":107,"numEvents":12}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":107,"numEvents":16}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":107,"numEvents":9}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Cytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Neutrophilia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Gastric polyps"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Rectal tenesmus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Varicella zoster virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Immunisation reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":107,"numEvents":1}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Skin papilloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Adenocarcinoma gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":107,"numEvents":3}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Polyneuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":107,"numEvents":1}],"term":"Post herpetic neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":107,"numEvents":8}],"term":"Haematuria"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":3}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Haemorrhagic diathesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":3}],"term":"Mast cell activation syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":5}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Coronary artery dissection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":3}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":4}],"term":"Intra-abdominal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Duodenal ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Gastritis erosive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Ileus paralytic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":3}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":105,"numEvents":0}],"term":"Lymphangiectasia intestinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Pancreatic fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":3}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":3}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Acute cholecystitis necrotic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Budd-Chiari syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":105,"numEvents":5}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":105,"numEvents":5}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":3}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":4}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":4}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Diverticulitis intestinal perforated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":4}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Appendiceal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":4}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Endocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Fournier's gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Gastroenteritis astroviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Groin abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":105,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Intervertebral discitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Parapharyngeal space infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Paraspinal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Septic endocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Spontaneous bacterial peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Stoma site cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Submandibular abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Urinary tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":3}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Cystitis radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Post procedural haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Post procedural hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Procedural nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Radiation proctitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Angiosarcoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Benign neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Bladder cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Lung adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Papillary thyroid cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":105,"numEvents":4}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Dementia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Nervous system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Polyneuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Bipolar disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":105,"numEvents":4}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":5}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":105,"numEvents":3}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":105,"numEvents":2}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Hypertonic bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Obstructive nephropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Bronchial haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Haemothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":2}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Pulmonary mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Thoracic haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Angiodysplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":105,"numEvents":0}],"term":"Lymphangiectasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":105,"numEvents":1}],"term":"Shock haemorrhagic"}],"timeFrame":"Day 1 through Month 65"}