{"description":"All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms \"Neoplasm progression\", \"Malignant neoplasm progression\" and \"Disease progression\" not related to study intervention were excluded.","eventGroups":[{"deathsNumAffected":79,"deathsNumAtRisk":160,"description":"Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.","id":"EG000","otherNumAffected":155,"otherNumAtRisk":158,"seriousNumAffected":76,"seriousNumAtRisk":158,"title":"Pembrolizumab + Lenvatinib"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Participants who experienced progression of Renal Cell Carcinoma (RCC) by radiographic evaluation continued second course treatment of 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 1 year PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.","id":"EG001","otherNumAffected":4,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Pembrolizumab + Lenvatinib Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":158,"numEvents":25},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":158,"numEvents":27},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":158,"numEvents":102},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":158,"numEvents":33},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":158,"numEvents":21},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":158,"numEvents":39},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":158,"numEvents":238},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":158,"numEvents":21},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":158,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":158,"numEvents":17},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":158,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":158,"numEvents":79},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":158,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":158,"numEvents":49},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":158,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":158,"numEvents":42},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":158,"numEvents":52},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":158,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":158,"numEvents":75},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":158,"numEvents":39},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":158,"numEvents":22},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":158,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":158,"numEvents":44},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":158,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":158,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":158,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Pertussis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":158,"numEvents":26},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":158,"numEvents":27},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":158,"numEvents":39},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":158,"numEvents":35},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":158,"numEvents":41},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":158,"numEvents":18},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":158,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":158,"numEvents":31},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":158,"numEvents":19},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood thyroid stimulating hormone increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":158,"numEvents":25},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":158,"numEvents":58},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":158,"numEvents":72},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":158,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":158,"numEvents":16},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":158,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":158,"numEvents":90},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":158,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":158,"numEvents":31},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":158,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":158,"numEvents":29},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":158,"numEvents":17},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":158,"numEvents":17},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":158,"numEvents":20},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":158,"numEvents":45},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":158,"numEvents":17},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":158,"numEvents":11},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":158,"numEvents":93},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":158,"numEvents":37},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":158,"numEvents":67},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":158,"numEvents":25},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":158,"numEvents":19},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":158,"numEvents":13},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":158,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":158,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":158,"numEvents":84},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":158,"numEvents":40},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":158,"numEvents":24},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":158,"numEvents":20},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":95,"numAtRisk":158,"numEvents":174},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":158,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":158,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":158,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Coronary artery stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Heart failure with reduced ejection fraction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Phimosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Immune-mediated hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal wall haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Anal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Autoimmune colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":158,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":158,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Immune-mediated enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Proctitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":158,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Incarcerated hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Immune-mediated hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acute sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":158,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Escherichia bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Lower respiratory tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":158,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Incisional hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":158,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Steroid diabetes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Type 1 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Tendonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":158,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cervical radiculopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haemorrhagic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Myelitis transverse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Posterior reversible encephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Completed suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hallucination"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Major depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Suicidal ideation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":158,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Autoimmune nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Immune-mediated lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":158,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":158,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":158,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vasculitis"}],"timeFrame":"Up to approximately 56 months"}