{"description":"All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms \"Neoplasm progression\" and \"Malignant neoplasm progression\" not related to study drug are excluded as AEs.","eventGroups":[{"deathsNumAffected":103,"deathsNumAtRisk":154,"description":"Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.","id":"EG000","otherNumAffected":140,"otherNumAtRisk":154,"seriousNumAffected":79,"seriousNumAtRisk":154,"title":"Pembrolizumab First Course"},{"deathsNumAffected":60,"deathsNumAtRisk":151,"description":"Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).","id":"EG001","otherNumAffected":142,"otherNumAtRisk":150,"seriousNumAffected":70,"seriousNumAtRisk":150,"title":"SOC Chemotherapy First Course"},{"deathsNumAffected":62,"deathsNumAtRisk":83,"description":"Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \\~2 years.","id":"EG002","otherNumAffected":72,"otherNumAtRisk":83,"seriousNumAffected":27,"seriousNumAtRisk":83,"title":"SOC Chemotherapy Switched Over to Pembrolizumab First Course"},{"deathsNumAffected":4,"deathsNumAtRisk":12,"description":"Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).","id":"EG003","otherNumAffected":10,"otherNumAtRisk":12,"seriousNumAffected":2,"seriousNumAtRisk":12,"title":"Pembrolizumab Second Course"},{"deathsNumAffected":1,"deathsNumAtRisk":1,"description":"One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \\~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to \\~1 additional year until documented PD or participant discontinuation.","id":"EG004","otherNumAffected":0,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"SOC Switched Over to Pembrolizumab Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":154,"numEvents":28},{"groupId":"EG001","numAffected":77,"numAtRisk":150,"numEvents":98},{"groupId":"EG002","numAffected":4,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":10,"numAtRisk":150,"numEvents":17},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":4},{"groupId":"EG001","numAffected":35,"numAtRisk":150,"numEvents":67},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":18,"numAtRisk":150,"numEvents":32},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":154,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":154,"numEvents":16},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":8,"numAtRisk":83,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Conjunctivitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":154,"numEvents":17},{"groupId":"EG001","numAffected":10,"numAtRisk":150,"numEvents":10},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":154,"numEvents":9},{"groupId":"EG001","numAffected":7,"numAtRisk":150,"numEvents":13},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":154,"numEvents":43},{"groupId":"EG001","numAffected":33,"numAtRisk":150,"numEvents":54},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":154,"numEvents":65},{"groupId":"EG001","numAffected":33,"numAtRisk":150,"numEvents":43},{"groupId":"EG002","numAffected":18,"numAtRisk":83,"numEvents":22},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":154,"numEvents":7},{"groupId":"EG001","numAffected":9,"numAtRisk":150,"numEvents":14},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":150,"numEvents":6},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":154,"numEvents":44},{"groupId":"EG001","numAffected":68,"numAtRisk":150,"numEvents":129},{"groupId":"EG002","numAffected":15,"numAtRisk":83,"numEvents":19},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":154,"numEvents":8},{"groupId":"EG001","numAffected":17,"numAtRisk":150,"numEvents":23},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":154,"numEvents":20},{"groupId":"EG001","numAffected":36,"numAtRisk":150,"numEvents":65},{"groupId":"EG002","numAffected":8,"numAtRisk":83,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":154,"numEvents":17},{"groupId":"EG001","numAffected":17,"numAtRisk":150,"numEvents":30},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":154,"numEvents":17},{"groupId":"EG001","numAffected":16,"numAtRisk":150,"numEvents":16},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":154,"numEvents":45},{"groupId":"EG001","numAffected":53,"numAtRisk":150,"numEvents":93},{"groupId":"EG002","numAffected":18,"numAtRisk":83,"numEvents":19},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":154,"numEvents":6},{"groupId":"EG001","numAffected":12,"numAtRisk":150,"numEvents":13},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":154,"numEvents":20},{"groupId":"EG001","numAffected":15,"numAtRisk":150,"numEvents":19},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":154,"numEvents":36},{"groupId":"EG001","numAffected":14,"numAtRisk":150,"numEvents":16},{"groupId":"EG002","numAffected":8,"numAtRisk":83,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":154,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":150,"numEvents":5},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Infected dermal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":154,"numEvents":27},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":9,"numAtRisk":83,"numEvents":10},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":154,"numEvents":18},{"groupId":"EG001","numAffected":5,"numAtRisk":150,"numEvents":7},{"groupId":"EG002","numAffected":9,"numAtRisk":83,"numEvents":12},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":154,"numEvents":11},{"groupId":"EG001","numAffected":8,"numAtRisk":150,"numEvents":11},{"groupId":"EG002","numAffected":4,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Eye injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":154,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":150,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":154,"numEvents":20},{"groupId":"EG001","numAffected":11,"numAtRisk":150,"numEvents":15},{"groupId":"EG002","numAffected":4,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":154,"numEvents":19},{"groupId":"EG001","numAffected":7,"numAtRisk":150,"numEvents":9},{"groupId":"EG002","numAffected":4,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":154,"numEvents":14},{"groupId":"EG001","numAffected":4,"numAtRisk":150,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":154,"numEvents":15},{"groupId":"EG001","numAffected":21,"numAtRisk":150,"numEvents":26},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":3},{"groupId":"EG001","numAffected":21,"numAtRisk":150,"numEvents":37},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":19,"numAtRisk":150,"numEvents":28},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":154,"numEvents":15},{"groupId":"EG001","numAffected":11,"numAtRisk":150,"numEvents":12},{"groupId":"EG002","numAffected":6,"numAtRisk":83,"numEvents":8},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":3},{"groupId":"EG001","numAffected":17,"numAtRisk":150,"numEvents":25},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":154,"numEvents":36},{"groupId":"EG001","numAffected":49,"numAtRisk":150,"numEvents":71},{"groupId":"EG002","numAffected":12,"numAtRisk":83,"numEvents":13},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":154,"numEvents":17},{"groupId":"EG001","numAffected":9,"numAtRisk":150,"numEvents":10},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":154,"numEvents":9},{"groupId":"EG001","numAffected":6,"numAtRisk":150,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":154,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":150,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":154,"numEvents":7},{"groupId":"EG001","numAffected":13,"numAtRisk":150,"numEvents":18},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":154,"numEvents":17},{"groupId":"EG001","numAffected":12,"numAtRisk":150,"numEvents":13},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":154,"numEvents":47},{"groupId":"EG001","numAffected":17,"numAtRisk":150,"numEvents":21},{"groupId":"EG002","numAffected":16,"numAtRisk":83,"numEvents":18},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":154,"numEvents":26},{"groupId":"EG001","numAffected":18,"numAtRisk":150,"numEvents":21},{"groupId":"EG002","numAffected":4,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":154,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":154,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":154,"numEvents":12},{"groupId":"EG001","numAffected":10,"numAtRisk":150,"numEvents":13},{"groupId":"EG002","numAffected":6,"numAtRisk":83,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Periarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":154,"numEvents":25},{"groupId":"EG001","numAffected":12,"numAtRisk":150,"numEvents":16},{"groupId":"EG002","numAffected":5,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":13,"numAtRisk":150,"numEvents":13},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":154,"numEvents":17},{"groupId":"EG001","numAffected":7,"numAtRisk":150,"numEvents":8},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":10,"numAtRisk":150,"numEvents":10},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":154,"numEvents":18},{"groupId":"EG001","numAffected":11,"numAtRisk":150,"numEvents":11},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":154,"numEvents":44},{"groupId":"EG001","numAffected":21,"numAtRisk":150,"numEvents":24},{"groupId":"EG002","numAffected":16,"numAtRisk":83,"numEvents":17},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":154,"numEvents":50},{"groupId":"EG001","numAffected":24,"numAtRisk":150,"numEvents":29},{"groupId":"EG002","numAffected":9,"numAtRisk":83,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":154,"numEvents":11},{"groupId":"EG001","numAffected":5,"numAtRisk":150,"numEvents":5},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":10},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":10,"numAtRisk":150,"numEvents":12},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":15,"numAtRisk":150,"numEvents":15},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":154,"numEvents":18},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":83,"numEvents":7},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Panniculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":154,"numEvents":46},{"groupId":"EG001","numAffected":6,"numAtRisk":150,"numEvents":6},{"groupId":"EG002","numAffected":13,"numAtRisk":83,"numEvents":13},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":154,"numEvents":43},{"groupId":"EG001","numAffected":7,"numAtRisk":150,"numEvents":8},{"groupId":"EG002","numAffected":8,"numAtRisk":83,"numEvents":13},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":154,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":83,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":154,"numEvents":13},{"groupId":"EG001","numAffected":4,"numAtRisk":150,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":154,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":150,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":150,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ischaemic cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Right ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":154,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":83,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastritis erosive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oral lichen planus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anaphylactic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bursitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Encephalomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Infective exacerbation of chronic obstructive airways disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":154,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Lymph gland infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Meningitis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Peritonsillar abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":154,"numEvents":7},{"groupId":"EG001","numAffected":13,"numAtRisk":150,"numEvents":13},{"groupId":"EG002","numAffected":2,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pulmonary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Splenic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anastomotic complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pulmonary radiation injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Radiation oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bilirubin conjugated increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood corticotrophin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cortisol decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fluid overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":154,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":154,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypovolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Haematoma muscle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Osteolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Appendix cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bladder cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bladder neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bladder transitional cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Colorectal adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Infected neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Brain injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Brown-Sequard syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Haemorrhagic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Device dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypertensive nephropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Tubulointerstitial nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ovarian haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bronchial obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":154,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Immune-mediated lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Laryngeal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Painful respiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":154,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":150,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":154,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pulmonary alveolar haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":154,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":150,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Lichen planus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Lichenoid keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":154,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":83,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":150,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Superior vena cava occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":154,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":150,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":83,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Vasospasm"}],"timeFrame":"Up to approximately 80 months."}