{"description":"All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms \"Neoplasm progression\", \"Malignant neoplasm progression\" and \"Disease progression\" not related to study intervention were excluded.","eventGroups":[{"deathsNumAffected":27,"deathsNumAtRisk":31,"description":"Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG000","otherNumAffected":30,"otherNumAtRisk":31,"seriousNumAffected":16,"seriousNumAtRisk":31,"title":"Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)"},{"deathsNumAffected":28,"deathsNumAtRisk":31,"description":"Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG001","otherNumAffected":31,"otherNumAtRisk":31,"seriousNumAffected":19,"seriousNumAtRisk":31,"title":"Cohort B: Ovarian Cancer (Lenva + Pembro)"},{"deathsNumAffected":97,"deathsNumAtRisk":102,"description":"Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG002","otherNumAffected":95,"otherNumAtRisk":99,"seriousNumAffected":57,"seriousNumAtRisk":99,"title":"Cohort C: Gastric Cancer (Lenva + Pembro)"},{"deathsNumAffected":97,"deathsNumAtRisk":107,"description":"Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG003","otherNumAffected":103,"otherNumAtRisk":105,"seriousNumAffected":55,"seriousNumAtRisk":105,"title":"Cohort D1: Colorectal Cancer (Lenva + Pembro)"},{"deathsNumAffected":30,"deathsNumAtRisk":32,"description":"Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG004","otherNumAffected":29,"otherNumAtRisk":30,"seriousNumAffected":12,"seriousNumAtRisk":30,"title":"Cohort D2: Colorectal Cancer (Lenva)"},{"deathsNumAffected":99,"deathsNumAtRisk":102,"description":"Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG005","otherNumAffected":98,"otherNumAtRisk":101,"seriousNumAffected":30,"seriousNumAtRisk":101,"title":"Cohort E: Glioblastoma Multiforma (Lenva + Pembro)"},{"deathsNumAffected":98,"deathsNumAtRisk":103,"description":"Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG006","otherNumAffected":100,"otherNumAtRisk":102,"seriousNumAffected":62,"seriousNumAtRisk":102,"title":"Cohort F: Biliary Tract Cancer (Lenva + Pembro)"},{"deathsNumAffected":101,"deathsNumAtRisk":103,"description":"Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.","id":"EG007","otherNumAffected":101,"otherNumAtRisk":103,"seriousNumAffected":49,"seriousNumAtRisk":103,"title":"Cohort G: Pancreatic Cancer (Lenva + Pembro)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":17,"numAtRisk":99,"numEvents":20},{"groupId":"EG003","numAffected":12,"numAtRisk":105,"numEvents":19},{"groupId":"EG004","numAffected":6,"numAtRisk":30,"numEvents":8},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":11,"numAtRisk":102,"numEvents":13},{"groupId":"EG007","numAffected":15,"numAtRisk":103,"numEvents":17}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":7},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":10,"numAtRisk":99,"numEvents":14},{"groupId":"EG003","numAffected":9,"numAtRisk":105,"numEvents":10},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":7,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":5},{"groupId":"EG007","numAffected":10,"numAtRisk":103,"numEvents":13}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":9,"numAtRisk":105,"numEvents":9},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":6},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":31,"numEvents":15},{"groupId":"EG001","numAffected":14,"numAtRisk":31,"numEvents":14},{"groupId":"EG002","numAffected":25,"numAtRisk":99,"numEvents":25},{"groupId":"EG003","numAffected":46,"numAtRisk":105,"numEvents":53},{"groupId":"EG004","numAffected":12,"numAtRisk":30,"numEvents":13},{"groupId":"EG005","numAffected":28,"numAtRisk":101,"numEvents":30},{"groupId":"EG006","numAffected":34,"numAtRisk":102,"numEvents":35},{"groupId":"EG007","numAffected":28,"numAtRisk":103,"numEvents":29}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":6}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":7},{"groupId":"EG001","numAffected":10,"numAtRisk":31,"numEvents":11},{"groupId":"EG002","numAffected":17,"numAtRisk":99,"numEvents":19},{"groupId":"EG003","numAffected":25,"numAtRisk":105,"numEvents":28},{"groupId":"EG004","numAffected":5,"numAtRisk":30,"numEvents":7},{"groupId":"EG005","numAffected":12,"numAtRisk":101,"numEvents":14},{"groupId":"EG006","numAffected":32,"numAtRisk":102,"numEvents":44},{"groupId":"EG007","numAffected":29,"numAtRisk":103,"numEvents":34}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":8,"numAtRisk":31,"numEvents":10},{"groupId":"EG002","numAffected":7,"numAtRisk":99,"numEvents":7},{"groupId":"EG003","numAffected":8,"numAtRisk":105,"numEvents":9},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":10,"numAtRisk":102,"numEvents":10},{"groupId":"EG007","numAffected":7,"numAtRisk":103,"numEvents":8}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":6},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":4}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7},{"groupId":"EG001","numAffected":11,"numAtRisk":31,"numEvents":11},{"groupId":"EG002","numAffected":17,"numAtRisk":99,"numEvents":18},{"groupId":"EG003","numAffected":22,"numAtRisk":105,"numEvents":25},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":14,"numAtRisk":101,"numEvents":15},{"groupId":"EG006","numAffected":24,"numAtRisk":102,"numEvents":27},{"groupId":"EG007","numAffected":19,"numAtRisk":103,"numEvents":24}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":31,"numEvents":34},{"groupId":"EG001","numAffected":19,"numAtRisk":31,"numEvents":38},{"groupId":"EG002","numAffected":30,"numAtRisk":99,"numEvents":40},{"groupId":"EG003","numAffected":47,"numAtRisk":105,"numEvents":74},{"groupId":"EG004","numAffected":16,"numAtRisk":30,"numEvents":44},{"groupId":"EG005","numAffected":26,"numAtRisk":101,"numEvents":43},{"groupId":"EG006","numAffected":42,"numAtRisk":102,"numEvents":67},{"groupId":"EG007","numAffected":25,"numAtRisk":103,"numEvents":41}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":31,"numEvents":9},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":7,"numAtRisk":105,"numEvents":9},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":11,"numAtRisk":102,"numEvents":11},{"groupId":"EG007","numAffected":8,"numAtRisk":103,"numEvents":9}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":9,"numAtRisk":105,"numEvents":9},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":8,"numAtRisk":102,"numEvents":9},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":4}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":5,"numAtRisk":105,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":31,"numEvents":17},{"groupId":"EG001","numAffected":15,"numAtRisk":31,"numEvents":21},{"groupId":"EG002","numAffected":31,"numAtRisk":99,"numEvents":32},{"groupId":"EG003","numAffected":34,"numAtRisk":105,"numEvents":45},{"groupId":"EG004","numAffected":5,"numAtRisk":30,"numEvents":7},{"groupId":"EG005","numAffected":19,"numAtRisk":101,"numEvents":21},{"groupId":"EG006","numAffected":37,"numAtRisk":102,"numEvents":55},{"groupId":"EG007","numAffected":37,"numAtRisk":103,"numEvents":50}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG002","numAffected":9,"numAtRisk":99,"numEvents":9},{"groupId":"EG003","numAffected":12,"numAtRisk":105,"numEvents":13},{"groupId":"EG004","numAffected":4,"numAtRisk":30,"numEvents":5},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":6},{"groupId":"EG006","numAffected":12,"numAtRisk":102,"numEvents":15},{"groupId":"EG007","numAffected":9,"numAtRisk":103,"numEvents":9}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":18},{"groupId":"EG001","numAffected":13,"numAtRisk":31,"numEvents":22},{"groupId":"EG002","numAffected":15,"numAtRisk":99,"numEvents":17},{"groupId":"EG003","numAffected":26,"numAtRisk":105,"numEvents":34},{"groupId":"EG004","numAffected":8,"numAtRisk":30,"numEvents":11},{"groupId":"EG005","numAffected":13,"numAtRisk":101,"numEvents":13},{"groupId":"EG006","numAffected":20,"numAtRisk":102,"numEvents":43},{"groupId":"EG007","numAffected":19,"numAtRisk":103,"numEvents":26}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":8},{"groupId":"EG002","numAffected":30,"numAtRisk":99,"numEvents":34},{"groupId":"EG003","numAffected":27,"numAtRisk":105,"numEvents":35},{"groupId":"EG004","numAffected":7,"numAtRisk":30,"numEvents":8},{"groupId":"EG005","numAffected":29,"numAtRisk":101,"numEvents":36},{"groupId":"EG006","numAffected":23,"numAtRisk":102,"numEvents":29},{"groupId":"EG007","numAffected":23,"numAtRisk":103,"numEvents":25}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":6},{"groupId":"EG007","numAffected":6,"numAtRisk":103,"numEvents":6}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":31,"numEvents":14},{"groupId":"EG001","numAffected":14,"numAtRisk":31,"numEvents":16},{"groupId":"EG002","numAffected":21,"numAtRisk":99,"numEvents":22},{"groupId":"EG003","numAffected":41,"numAtRisk":105,"numEvents":47},{"groupId":"EG004","numAffected":9,"numAtRisk":30,"numEvents":11},{"groupId":"EG005","numAffected":20,"numAtRisk":101,"numEvents":22},{"groupId":"EG006","numAffected":40,"numAtRisk":102,"numEvents":52},{"groupId":"EG007","numAffected":31,"numAtRisk":103,"numEvents":35}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":10},{"groupId":"EG001","numAffected":10,"numAtRisk":31,"numEvents":10},{"groupId":"EG002","numAffected":9,"numAtRisk":99,"numEvents":10},{"groupId":"EG003","numAffected":10,"numAtRisk":105,"numEvents":12},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":11,"numAtRisk":101,"numEvents":14},{"groupId":"EG006","numAffected":15,"numAtRisk":102,"numEvents":18},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":5}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":15,"numAtRisk":105,"numEvents":16},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":5},{"groupId":"EG006","numAffected":13,"numAtRisk":102,"numEvents":13},{"groupId":"EG007","numAffected":19,"numAtRisk":103,"numEvents":20}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":8,"numAtRisk":99,"numEvents":9},{"groupId":"EG003","numAffected":11,"numAtRisk":105,"numEvents":14},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":8,"numAtRisk":101,"numEvents":13},{"groupId":"EG006","numAffected":11,"numAtRisk":102,"numEvents":15},{"groupId":"EG007","numAffected":19,"numAtRisk":103,"numEvents":23}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":2}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":10},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":7,"numAtRisk":105,"numEvents":8},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":5},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":7,"numAtRisk":102,"numEvents":7},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":5}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":9,"numAtRisk":101,"numEvents":9},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":12},{"groupId":"EG001","numAffected":7,"numAtRisk":31,"numEvents":17},{"groupId":"EG002","numAffected":12,"numAtRisk":99,"numEvents":18},{"groupId":"EG003","numAffected":24,"numAtRisk":105,"numEvents":34},{"groupId":"EG004","numAffected":10,"numAtRisk":30,"numEvents":14},{"groupId":"EG005","numAffected":22,"numAtRisk":101,"numEvents":33},{"groupId":"EG006","numAffected":21,"numAtRisk":102,"numEvents":25},{"groupId":"EG007","numAffected":14,"numAtRisk":103,"numEvents":17}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":99,"numEvents":9},{"groupId":"EG003","numAffected":7,"numAtRisk":105,"numEvents":10},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":10},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":6,"numAtRisk":103,"numEvents":8}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":11},{"groupId":"EG001","numAffected":8,"numAtRisk":31,"numEvents":17},{"groupId":"EG002","numAffected":18,"numAtRisk":99,"numEvents":25},{"groupId":"EG003","numAffected":24,"numAtRisk":105,"numEvents":35},{"groupId":"EG004","numAffected":7,"numAtRisk":30,"numEvents":8},{"groupId":"EG005","numAffected":20,"numAtRisk":101,"numEvents":27},{"groupId":"EG006","numAffected":26,"numAtRisk":102,"numEvents":31},{"groupId":"EG007","numAffected":19,"numAtRisk":103,"numEvents":24}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Blood albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":7},{"groupId":"EG002","numAffected":14,"numAtRisk":99,"numEvents":14},{"groupId":"EG003","numAffected":13,"numAtRisk":105,"numEvents":15},{"groupId":"EG004","numAffected":11,"numAtRisk":30,"numEvents":14},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":14,"numAtRisk":102,"numEvents":14},{"groupId":"EG007","numAffected":9,"numAtRisk":103,"numEvents":13}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":99,"numEvents":8},{"groupId":"EG003","numAffected":15,"numAtRisk":105,"numEvents":24},{"groupId":"EG004","numAffected":6,"numAtRisk":30,"numEvents":8},{"groupId":"EG005","numAffected":7,"numAtRisk":101,"numEvents":7},{"groupId":"EG006","numAffected":15,"numAtRisk":102,"numEvents":17},{"groupId":"EG007","numAffected":8,"numAtRisk":103,"numEvents":9}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":6,"numAtRisk":105,"numEvents":12},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":6},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Blood cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":4}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":7},{"groupId":"EG003","numAffected":12,"numAtRisk":105,"numEvents":17},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":6},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":8},{"groupId":"EG007","numAffected":11,"numAtRisk":103,"numEvents":11}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":9},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":4}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Blood magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Blood sodium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":8,"numAtRisk":105,"numEvents":17},{"groupId":"EG004","numAffected":4,"numAtRisk":30,"numEvents":5},{"groupId":"EG005","numAffected":7,"numAtRisk":101,"numEvents":11},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Blood thyroid stimulating hormone increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":4}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":99,"numEvents":7},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":8,"numAtRisk":99,"numEvents":9},{"groupId":"EG003","numAffected":12,"numAtRisk":105,"numEvents":14},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":5},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":8},{"groupId":"EG007","numAffected":7,"numAtRisk":103,"numEvents":10}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":105,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":7,"numAtRisk":101,"numEvents":11},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":5},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":3}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":6}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":9,"numAtRisk":99,"numEvents":10},{"groupId":"EG003","numAffected":8,"numAtRisk":105,"numEvents":10},{"groupId":"EG004","numAffected":6,"numAtRisk":30,"numEvents":8},{"groupId":"EG005","numAffected":7,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":7,"numAtRisk":102,"numEvents":7},{"groupId":"EG007","numAffected":12,"numAtRisk":103,"numEvents":17}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Platelet count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":9},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":7}],"term":"Protein total decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":9},{"groupId":"EG001","numAffected":7,"numAtRisk":31,"numEvents":8},{"groupId":"EG002","numAffected":15,"numAtRisk":99,"numEvents":15},{"groupId":"EG003","numAffected":13,"numAtRisk":105,"numEvents":13},{"groupId":"EG004","numAffected":8,"numAtRisk":30,"numEvents":9},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":6},{"groupId":"EG006","numAffected":10,"numAtRisk":102,"numEvents":10},{"groupId":"EG007","numAffected":22,"numAtRisk":103,"numEvents":23}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31,"numEvents":12},{"groupId":"EG001","numAffected":15,"numAtRisk":31,"numEvents":20},{"groupId":"EG002","numAffected":30,"numAtRisk":99,"numEvents":31},{"groupId":"EG003","numAffected":46,"numAtRisk":105,"numEvents":50},{"groupId":"EG004","numAffected":6,"numAtRisk":30,"numEvents":6},{"groupId":"EG005","numAffected":19,"numAtRisk":101,"numEvents":20},{"groupId":"EG006","numAffected":37,"numAtRisk":102,"numEvents":44},{"groupId":"EG007","numAffected":33,"numAtRisk":103,"numEvents":40}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":4}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":6,"numAtRisk":105,"numEvents":7},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":4},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":11},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":7,"numAtRisk":103,"numEvents":9}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":4,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":5},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":105,"numEvents":17},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":5},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":9,"numAtRisk":99,"numEvents":9},{"groupId":"EG003","numAffected":11,"numAtRisk":105,"numEvents":11},{"groupId":"EG004","numAffected":5,"numAtRisk":30,"numEvents":5},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":7},{"groupId":"EG007","numAffected":9,"numAtRisk":103,"numEvents":11}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":6},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":4,"numAtRisk":105,"numEvents":7},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":9,"numAtRisk":101,"numEvents":11},{"groupId":"EG006","numAffected":8,"numAtRisk":102,"numEvents":12},{"groupId":"EG007","numAffected":13,"numAtRisk":103,"numEvents":15}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":17},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":5,"numAtRisk":105,"numEvents":6},{"groupId":"EG004","numAffected":6,"numAtRisk":30,"numEvents":9},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":9},{"groupId":"EG006","numAffected":7,"numAtRisk":102,"numEvents":9},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":5}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":99,"numEvents":8},{"groupId":"EG003","numAffected":5,"numAtRisk":105,"numEvents":6},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":12,"numAtRisk":102,"numEvents":14},{"groupId":"EG007","numAffected":12,"numAtRisk":103,"numEvents":15}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":5,"numAtRisk":105,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":18},{"groupId":"EG001","numAffected":11,"numAtRisk":31,"numEvents":17},{"groupId":"EG002","numAffected":10,"numAtRisk":99,"numEvents":13},{"groupId":"EG003","numAffected":21,"numAtRisk":105,"numEvents":26},{"groupId":"EG004","numAffected":4,"numAtRisk":30,"numEvents":4},{"groupId":"EG005","numAffected":12,"numAtRisk":101,"numEvents":15},{"groupId":"EG006","numAffected":18,"numAtRisk":102,"numEvents":22},{"groupId":"EG007","numAffected":16,"numAtRisk":103,"numEvents":19}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":13,"numAtRisk":99,"numEvents":14},{"groupId":"EG003","numAffected":20,"numAtRisk":105,"numEvents":23},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":15,"numAtRisk":102,"numEvents":15},{"groupId":"EG007","numAffected":12,"numAtRisk":103,"numEvents":12}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":101,"numEvents":3},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":6,"numAtRisk":105,"numEvents":6},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":4}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":31,"numEvents":7},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":17,"numAtRisk":105,"numEvents":17},{"groupId":"EG004","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":8,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":7},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":5}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":3},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":6,"numAtRisk":105,"numEvents":8},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":7},{"groupId":"EG006","numAffected":5,"numAtRisk":102,"numEvents":6},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":2}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":8,"numAtRisk":101,"numEvents":8},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":7,"numAtRisk":105,"numEvents":7},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":3,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":5}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":5,"numAtRisk":102,"numEvents":5},{"groupId":"EG007","numAffected":9,"numAtRisk":103,"numEvents":9}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":16},{"groupId":"EG001","numAffected":10,"numAtRisk":31,"numEvents":16},{"groupId":"EG002","numAffected":7,"numAtRisk":99,"numEvents":8},{"groupId":"EG003","numAffected":18,"numAtRisk":105,"numEvents":21},{"groupId":"EG004","numAffected":6,"numAtRisk":30,"numEvents":11},{"groupId":"EG005","numAffected":25,"numAtRisk":101,"numEvents":29},{"groupId":"EG006","numAffected":25,"numAtRisk":102,"numEvents":28},{"groupId":"EG007","numAffected":22,"numAtRisk":103,"numEvents":25}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":3}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":9,"numAtRisk":105,"numEvents":9},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":6},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":4}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":99,"numEvents":5},{"groupId":"EG003","numAffected":9,"numAtRisk":105,"numEvents":10},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":5},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":6},{"groupId":"EG007","numAffected":8,"numAtRisk":103,"numEvents":10}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":6,"numAtRisk":101,"numEvents":6},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":103,"numEvents":4}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":5},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Leukocyturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":8},{"groupId":"EG001","numAffected":13,"numAtRisk":31,"numEvents":18},{"groupId":"EG002","numAffected":12,"numAtRisk":99,"numEvents":13},{"groupId":"EG003","numAffected":39,"numAtRisk":105,"numEvents":52},{"groupId":"EG004","numAffected":11,"numAtRisk":30,"numEvents":12},{"groupId":"EG005","numAffected":12,"numAtRisk":101,"numEvents":15},{"groupId":"EG006","numAffected":23,"numAtRisk":102,"numEvents":24},{"groupId":"EG007","numAffected":22,"numAtRisk":103,"numEvents":25}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":10,"numAtRisk":105,"numEvents":10},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":9,"numAtRisk":101,"numEvents":9},{"groupId":"EG006","numAffected":11,"numAtRisk":102,"numEvents":15},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":5}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":20,"numAtRisk":99,"numEvents":20},{"groupId":"EG003","numAffected":21,"numAtRisk":105,"numEvents":21},{"groupId":"EG004","numAffected":12,"numAtRisk":30,"numEvents":14},{"groupId":"EG005","numAffected":11,"numAtRisk":101,"numEvents":12},{"groupId":"EG006","numAffected":31,"numAtRisk":102,"numEvents":34},{"groupId":"EG007","numAffected":17,"numAtRisk":103,"numEvents":18}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":7,"numAtRisk":105,"numEvents":8},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":5},{"groupId":"EG006","numAffected":14,"numAtRisk":102,"numEvents":15},{"groupId":"EG007","numAffected":7,"numAtRisk":103,"numEvents":8}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":99,"numEvents":8},{"groupId":"EG003","numAffected":4,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":101,"numEvents":6},{"groupId":"EG006","numAffected":9,"numAtRisk":102,"numEvents":11},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":6,"numAtRisk":99,"numEvents":6},{"groupId":"EG003","numAffected":6,"numAtRisk":105,"numEvents":6},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":7,"numAtRisk":102,"numEvents":7},{"groupId":"EG007","numAffected":7,"numAtRisk":103,"numEvents":7}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG002","numAffected":10,"numAtRisk":99,"numEvents":10},{"groupId":"EG003","numAffected":8,"numAtRisk":105,"numEvents":8},{"groupId":"EG004","numAffected":5,"numAtRisk":30,"numEvents":6},{"groupId":"EG005","numAffected":10,"numAtRisk":101,"numEvents":10},{"groupId":"EG006","numAffected":12,"numAtRisk":102,"numEvents":13},{"groupId":"EG007","numAffected":12,"numAtRisk":103,"numEvents":14}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":7},{"groupId":"EG002","numAffected":13,"numAtRisk":99,"numEvents":13},{"groupId":"EG003","numAffected":9,"numAtRisk":105,"numEvents":10},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":15,"numAtRisk":102,"numEvents":20},{"groupId":"EG007","numAffected":8,"numAtRisk":103,"numEvents":11}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":13,"numAtRisk":105,"numEvents":16},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":3},{"groupId":"EG005","numAffected":14,"numAtRisk":101,"numEvents":18},{"groupId":"EG006","numAffected":16,"numAtRisk":102,"numEvents":19},{"groupId":"EG007","numAffected":15,"numAtRisk":103,"numEvents":17}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":5,"numAtRisk":105,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":5},{"groupId":"EG007","numAffected":4,"numAtRisk":103,"numEvents":4}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":31,"numEvents":25},{"groupId":"EG001","numAffected":21,"numAtRisk":31,"numEvents":28},{"groupId":"EG002","numAffected":37,"numAtRisk":99,"numEvents":42},{"groupId":"EG003","numAffected":59,"numAtRisk":105,"numEvents":92},{"groupId":"EG004","numAffected":17,"numAtRisk":30,"numEvents":22},{"groupId":"EG005","numAffected":51,"numAtRisk":101,"numEvents":65},{"groupId":"EG006","numAffected":58,"numAtRisk":102,"numEvents":74},{"groupId":"EG007","numAffected":55,"numAtRisk":103,"numEvents":65}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":7},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Haemolytic uraemic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypersensitivity myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":99,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":8},{"groupId":"EG007","numAffected":5,"numAtRisk":103,"numEvents":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Abdominal wall haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Colitis ischaemic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Diverticulum intestinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Duodenal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Duodenal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Duodenal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Gastric haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Gastric ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Gastrointestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Immune-mediated enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Immune-mediated pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Intestinal dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Intestinal pseudo-obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Intra-abdominal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Jejunal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Oesophageal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Oesophageal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Varices oesophageal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":101,"numEvents":4},{"groupId":"EG006","numAffected":7,"numAtRisk":102,"numEvents":9},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":102,"numEvents":5},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Biliary obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Biliary tract disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":6,"numAtRisk":102,"numEvents":6},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Cholangitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hepatic cirrhosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Immune-mediated hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Abdominal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Abdominal wall abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Anorectal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Bacteroides infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Biliary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":5},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Encephalitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Extradural abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Infective aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":2}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Meningitis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Periorbital cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Pulmonary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Scrotal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":105,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Vascular device infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cervical vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Craniocerebral injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"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":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Intestinal anastomosis complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Pelvic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Stoma site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Stomal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Urinary tract stoma complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Thyroid cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Transitional cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"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":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Embolic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Intracranial pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Metabolic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Myasthenic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Neurotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Paraneoplastic neurological syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Spinal cord haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Status epilepticus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Vascular encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Vasogenic cerebral oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Wernicke's encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Device dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Stent malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":105,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":4,"numAtRisk":102,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Nephrotic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Ureterolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Lung consolidation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Lung disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":99,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":101,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":103,"numEvents":3}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Loss of personal independence in daily activities"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Assisted suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":101,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":102,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypertensive crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypertensive urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Hypovolaemic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Iliac artery occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":105,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":103,"numEvents":0}],"term":"Vasculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":105,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":101,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":102,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":103,"numEvents":1}],"term":"Venous haemorrhage"}],"timeFrame":"Up to approximately 66 months"}