{"description":"All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.","eventGroups":[{"deathsNumAffected":689,"deathsNumAtRisk":790,"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).\n\nParticipants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).","id":"EG000","otherNumAffected":755,"otherNumAtRisk":785,"seriousNumAffected":358,"seriousNumAtRisk":785,"title":"Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)"},{"deathsNumAffected":733,"deathsNumAtRisk":789,"description":"Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\\^2 IV on Day 1 Q3W and 5FU 800 mg/m\\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).","id":"EG001","otherNumAffected":751,"otherNumAtRisk":787,"seriousNumAffected":317,"seriousNumAtRisk":787,"title":"Placebo + Chemotherapy (FP or CAPOX Regimen)"},{"deathsNumAffected":8,"deathsNumAtRisk":12,"description":"Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule of 200 mg IV on Day 1 Q3W for up to 17 cycles (up to approximately 1 year).","id":"EG002","otherNumAffected":10,"otherNumAtRisk":12,"seriousNumAffected":1,"seriousNumAtRisk":12,"title":"Pembrolizumab Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":325,"numAtRisk":785,"numEvents":512},{"groupId":"EG001","numAffected":282,"numAtRisk":787,"numEvents":413},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":4}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":785,"numEvents":76},{"groupId":"EG001","numAffected":42,"numAtRisk":787,"numEvents":79},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":3}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":785,"numEvents":38},{"groupId":"EG001","numAffected":16,"numAtRisk":787,"numEvents":25},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":146,"numAtRisk":785,"numEvents":309},{"groupId":"EG001","numAffected":141,"numAtRisk":787,"numEvents":294},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":4}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":95,"numAtRisk":785,"numEvents":147},{"groupId":"EG001","numAffected":83,"numAtRisk":787,"numEvents":137},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":785,"numEvents":23},{"groupId":"EG001","numAffected":15,"numAtRisk":787,"numEvents":16},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":785,"numEvents":44},{"groupId":"EG001","numAffected":13,"numAtRisk":787,"numEvents":15},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":121,"numAtRisk":785,"numEvents":139},{"groupId":"EG001","numAffected":34,"numAtRisk":787,"numEvents":40},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Erythema of eyelid"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Eye swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":785,"numEvents":43},{"groupId":"EG001","numAffected":40,"numAtRisk":787,"numEvents":42},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":130,"numAtRisk":785,"numEvents":165},{"groupId":"EG001","numAffected":111,"numAtRisk":787,"numEvents":137},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":785,"numEvents":72},{"groupId":"EG001","numAffected":62,"numAtRisk":787,"numEvents":68},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":169,"numAtRisk":785,"numEvents":207},{"groupId":"EG001","numAffected":161,"numAtRisk":787,"numEvents":209},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":255,"numAtRisk":785,"numEvents":443},{"groupId":"EG001","numAffected":238,"numAtRisk":787,"numEvents":357},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":3}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":785,"numEvents":52},{"groupId":"EG001","numAffected":39,"numAtRisk":787,"numEvents":45},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":785,"numEvents":50},{"groupId":"EG001","numAffected":35,"numAtRisk":787,"numEvents":39},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":359,"numAtRisk":785,"numEvents":626},{"groupId":"EG001","numAffected":359,"numAtRisk":787,"numEvents":612},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":785,"numEvents":72},{"groupId":"EG001","numAffected":48,"numAtRisk":787,"numEvents":53},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":252,"numAtRisk":785,"numEvents":423},{"groupId":"EG001","numAffected":192,"numAtRisk":787,"numEvents":312},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Vomiting projectile"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":125,"numAtRisk":785,"numEvents":196},{"groupId":"EG001","numAffected":119,"numAtRisk":787,"numEvents":164},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":195,"numAtRisk":785,"numEvents":255},{"groupId":"EG001","numAffected":191,"numAtRisk":787,"numEvents":262},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":785,"numEvents":64},{"groupId":"EG001","numAffected":38,"numAtRisk":787,"numEvents":50},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":785,"numEvents":73},{"groupId":"EG001","numAffected":55,"numAtRisk":787,"numEvents":61},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":785,"numEvents":132},{"groupId":"EG001","numAffected":51,"numAtRisk":787,"numEvents":63},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":7,"numAtRisk":787,"numEvents":12},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Abscess oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":785,"numEvents":14},{"groupId":"EG001","numAffected":12,"numAtRisk":787,"numEvents":12},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Oral fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Periodontitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":785,"numEvents":31},{"groupId":"EG001","numAffected":23,"numAtRisk":787,"numEvents":28},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":133,"numAtRisk":785,"numEvents":179},{"groupId":"EG001","numAffected":96,"numAtRisk":787,"numEvents":124},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":183,"numAtRisk":785,"numEvents":287},{"groupId":"EG001","numAffected":139,"numAtRisk":787,"numEvents":194},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":82,"numAtRisk":785,"numEvents":103},{"groupId":"EG001","numAffected":68,"numAtRisk":787,"numEvents":78},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":108,"numAtRisk":785,"numEvents":195},{"groupId":"EG001","numAffected":71,"numAtRisk":787,"numEvents":133},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":785,"numEvents":62},{"groupId":"EG001","numAffected":40,"numAtRisk":787,"numEvents":46},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":785,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":199,"numAtRisk":785,"numEvents":554},{"groupId":"EG001","numAffected":175,"numAtRisk":787,"numEvents":509},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":207,"numAtRisk":785,"numEvents":424},{"groupId":"EG001","numAffected":187,"numAtRisk":787,"numEvents":319},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":158,"numAtRisk":785,"numEvents":178},{"groupId":"EG001","numAffected":147,"numAtRisk":787,"numEvents":161},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":108,"numAtRisk":785,"numEvents":336},{"groupId":"EG001","numAffected":93,"numAtRisk":787,"numEvents":292},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":227,"numAtRisk":785,"numEvents":302},{"groupId":"EG001","numAffected":217,"numAtRisk":787,"numEvents":293},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":785,"numEvents":110},{"groupId":"EG001","numAffected":43,"numAtRisk":787,"numEvents":54},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":146,"numAtRisk":785,"numEvents":213},{"groupId":"EG001","numAffected":105,"numAtRisk":787,"numEvents":152},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":785,"numEvents":72},{"groupId":"EG001","numAffected":46,"numAtRisk":787,"numEvents":52},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":116,"numAtRisk":785,"numEvents":162},{"groupId":"EG001","numAffected":84,"numAtRisk":787,"numEvents":113},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":785,"numEvents":68},{"groupId":"EG001","numAffected":39,"numAtRisk":787,"numEvents":48},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":73,"numAtRisk":785,"numEvents":90},{"groupId":"EG001","numAffected":57,"numAtRisk":787,"numEvents":68},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":785,"numEvents":52},{"groupId":"EG001","numAffected":45,"numAtRisk":787,"numEvents":45},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Rotator cuff syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":785,"numEvents":58},{"groupId":"EG001","numAffected":38,"numAtRisk":787,"numEvents":44},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":785,"numEvents":55},{"groupId":"EG001","numAffected":37,"numAtRisk":787,"numEvents":44},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":157,"numAtRisk":785,"numEvents":215},{"groupId":"EG001","numAffected":175,"numAtRisk":787,"numEvents":231},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":785,"numEvents":74},{"groupId":"EG001","numAffected":32,"numAtRisk":787,"numEvents":61},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":139,"numAtRisk":785,"numEvents":189},{"groupId":"EG001","numAffected":136,"numAtRisk":787,"numEvents":184},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":785,"numEvents":23},{"groupId":"EG001","numAffected":12,"numAtRisk":787,"numEvents":12},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":785,"numEvents":47},{"groupId":"EG001","numAffected":52,"numAtRisk":787,"numEvents":55},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":785,"numEvents":44},{"groupId":"EG001","numAffected":30,"numAtRisk":787,"numEvents":32},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":195,"numAtRisk":785,"numEvents":225},{"groupId":"EG001","numAffected":172,"numAtRisk":787,"numEvents":188},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":785,"numEvents":91},{"groupId":"EG001","numAffected":21,"numAtRisk":787,"numEvents":30},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":785,"numEvents":98},{"groupId":"EG001","numAffected":39,"numAtRisk":787,"numEvents":44},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rash"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":785,"numEvents":10},{"groupId":"EG001","numAffected":8,"numAtRisk":787,"numEvents":10},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aplastic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Autoimmune haemolytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood loss anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":787,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Myelosuppression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":787,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Angina unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arteriospasm coronary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardiac failure chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardiac tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune-mediated myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyloric stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypopituitarism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diabetic retinopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Retinal artery occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":785,"numEvents":12},{"groupId":"EG001","numAffected":9,"numAtRisk":787,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":785,"numEvents":6},{"groupId":"EG001","numAffected":9,"numAtRisk":787,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":785,"numEvents":16},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Colitis ischaemic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":787,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":785,"numEvents":35},{"groupId":"EG001","numAffected":25,"numAtRisk":787,"numEvents":26},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Duodenal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":785,"numEvents":9},{"groupId":"EG001","numAffected":15,"numAtRisk":787,"numEvents":15},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Food poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":785,"numEvents":5},{"groupId":"EG001","numAffected":7,"numAtRisk":787,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastric haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":785,"numEvents":12},{"groupId":"EG001","numAffected":8,"numAtRisk":787,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":785,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":787,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune-mediated enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Impaired gastric emptying"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Intestinal ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":785,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":787,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Intestinal pseudo-obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Large intestine polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Malignant ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Mechanical ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":785,"numEvents":14},{"groupId":"EG001","numAffected":11,"numAtRisk":787,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neutropenic colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":9,"numAtRisk":787,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Obstructive pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oesophageal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oesophageal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumoperitoneum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Small intestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Small intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Terminal ileitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":785,"numEvents":9},{"groupId":"EG001","numAffected":8,"numAtRisk":787,"numEvents":8},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":785,"numEvents":20},{"groupId":"EG001","numAffected":23,"numAtRisk":787,"numEvents":24},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":787,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Complication associated with device"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":785,"numEvents":11},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":787,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperthermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Injection site discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":787,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":785,"numEvents":16},{"groupId":"EG001","numAffected":9,"numAtRisk":787,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Biliary fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Biliary obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":12},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholestasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune-mediated hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vanishing bile duct syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Appendicitis perforated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Biliary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":785,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":785,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Campylobacter gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Campylobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chlamydial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholangitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Endocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Epiglottitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Febrile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Klebsiella sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lymph node abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pleural infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":785,"numEvents":30},{"groupId":"EG001","numAffected":14,"numAtRisk":787,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonia cytomegaloviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":785,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":787,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Septic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":787,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Streptococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Streptococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tinea manuum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tinea pedis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Clavicle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal anastomotic stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":785,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Jaw fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Meniscus injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Multiple fractures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Multiple injuries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral nerve injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Subdural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Unintentional medical device removal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Creatinine renal clearance decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"False positive investigation result"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":785,"numEvents":7},{"groupId":"EG001","numAffected":7,"numAtRisk":787,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"SARS-CoV-2 test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":785,"numEvents":9},{"groupId":"EG001","numAffected":10,"numAtRisk":787,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":785,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":785,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":787,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":785,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Type 1 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Paraneoplastic dermatomyositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sacral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Spondylitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acoustic neuroma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Colorectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastric cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neuroendocrine tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pharyngeal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Prostate cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lacunar stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Myasthenia gravis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neurotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Optic neuritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Paraneoplastic encephalomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":787,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Device breakage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Device dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Device occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Stent malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Completed suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Substance-induced psychotic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":785,"numEvents":13},{"groupId":"EG001","numAffected":11,"numAtRisk":787,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune-mediated nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tubulointerstitial nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ureteric obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ureterolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Endometrial hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune-mediated lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":785,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Laryngospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oropharyngeal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":785,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pleurisy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":785,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":787,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":785,"numEvents":15},{"groupId":"EG001","numAffected":6,"numAtRisk":787,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pulmonary thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aortic dissection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aortic thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arteriosclerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":785,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":787,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Jugular vein embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral artery occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":787,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":785,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peripheral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":785,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":787,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Venous thrombosis"}],"timeFrame":"Up to approximately 49.3 months"}