{"eventGroups":[{"description":"Cycles 1-2 (21-day cycle):\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nDay 2: LY2603618 130 to 275 mg\n\nAfter 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.\n\nPemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.","id":"EG000","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":1,"seriousNumAtRisk":14,"title":"Phase 1: Pemetrexed + Cisplatin + LY2603618"},{"description":"Cycles 1-4 (21-day cycle):\n\nBefore 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nDay 2: LY2603618 dose determined from phase 1 (275 mg)\n\nAfter 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nAfter 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.\n\nMaintenance therapy (every 21 days):\n\nBefore 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2\n\nDay 2: LY2603618 dose determined from phase 1 (275 mg)\n\nAfter 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2\n\nIf, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.\n\nPemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.","id":"EG001","otherNumAffected":37,"otherNumAtRisk":39,"seriousNumAffected":16,"seriousNumAtRisk":39,"title":"Phase 2: Pemetrexed + Cisplatin + LY2603618"},{"description":"Cycles 1-4 (21-day cycle):\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nAfter 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.\n\nMaintenance therapy (every 21 days):\n\nDay 1: pemetrexed 500 mg/m\\^2\n\nPemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.","id":"EG002","otherNumAffected":22,"otherNumAtRisk":22,"seriousNumAffected":6,"seriousNumAtRisk":22,"title":"Phase 2: Pemetrexed + Cisplatin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":16},{"groupId":"EG001","numAffected":7,"numAtRisk":39,"numEvents":16},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":14,"numEvents":13},{"groupId":"EG001","numAffected":8,"numAtRisk":39,"numEvents":11},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":7}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Thrombocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":39,"numEvents":22},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Ototoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":7},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":4}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Eye oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Eyelid oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Papilloedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":4},{"groupId":"EG001","numAffected":18,"numAtRisk":39,"numEvents":30},{"groupId":"EG002","numAffected":8,"numAtRisk":22,"numEvents":13}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":5},{"groupId":"EG001","numAffected":11,"numAtRisk":39,"numEvents":17},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":6}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":14,"numEvents":44},{"groupId":"EG001","numAffected":30,"numAtRisk":39,"numEvents":106},{"groupId":"EG002","numAffected":15,"numAtRisk":22,"numEvents":27}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":14,"numEvents":13},{"groupId":"EG001","numAffected":18,"numAtRisk":39,"numEvents":42},{"groupId":"EG002","numAffected":6,"numAtRisk":22,"numEvents":9}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":17,"numAtRisk":39,"numEvents":82},{"groupId":"EG002","numAffected":5,"numAtRisk":22,"numEvents":12}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Catheter site related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Catheter site swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":3}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":4}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":14,"numEvents":35},{"groupId":"EG001","numAffected":14,"numAtRisk":39,"numEvents":23},{"groupId":"EG002","numAffected":14,"numAtRisk":22,"numEvents":21}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Infusion site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Infusion site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":10,"numAtRisk":39,"numEvents":22},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":7}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":39,"numEvents":10},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":14,"numEvents":8},{"groupId":"EG001","numAffected":10,"numAtRisk":39,"numEvents":19},{"groupId":"EG002","numAffected":9,"numAtRisk":22,"numEvents":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Herpes simplex"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Contrast media reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":5}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":3}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":14,"numAtRisk":39,"numEvents":45},{"groupId":"EG002","numAffected":12,"numAtRisk":22,"numEvents":19}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Dyslipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":4}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":39,"numEvents":11},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":6}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":39,"numEvents":12},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Dysaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":5},{"groupId":"EG001","numAffected":8,"numAtRisk":39,"numEvents":17},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":3}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":39,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Neurotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":14,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":4}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Menstruation irregular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":4},{"groupId":"EG001","numAffected":8,"numAtRisk":39,"numEvents":19},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":4}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":12,"numAtRisk":39,"numEvents":16},{"groupId":"EG002","numAffected":7,"numAtRisk":22,"numEvents":9}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":3}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":4}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Sneezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":14,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":22,"numEvents":4}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Skin discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Catheterisation venous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Circulatory collapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":39,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hypertensive crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Phlebitis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Urinary tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Tibia fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Metastases to bone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Metastatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":39,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":39,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":39,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Respiratory failure"}]}