{"description":"All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.","eventGroups":[{"deathsNumAffected":263,"deathsNumAtRisk":300,"description":"Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.","id":"EG000","otherNumAffected":272,"otherNumAtRisk":299,"seriousNumAffected":76,"seriousNumAtRisk":299,"title":"Pembrolizumab First Course"},{"deathsNumAffected":146,"deathsNumAtRisk":153,"description":"Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.","id":"EG001","otherNumAffected":135,"otherNumAtRisk":153,"seriousNumAffected":31,"seriousNumAtRisk":153,"title":"Placebo First Course"},{"deathsNumAffected":8,"deathsNumAtRisk":12,"description":"Eligible participants randomized to the pembrolizumab first course who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year","id":"EG002","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":1,"seriousNumAtRisk":12,"title":"Pembrolizumab Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":299,"numEvents":55},{"groupId":"EG001","numAffected":16,"numAtRisk":153,"numEvents":17},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":299,"numEvents":16},{"groupId":"EG001","numAffected":3,"numAtRisk":153,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":299,"numEvents":35},{"groupId":"EG001","numAffected":11,"numAtRisk":153,"numEvents":13},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":299,"numEvents":18},{"groupId":"EG001","numAffected":4,"numAtRisk":153,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":299,"numEvents":26},{"groupId":"EG001","numAffected":12,"numAtRisk":153,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":299,"numEvents":20},{"groupId":"EG001","numAffected":4,"numAtRisk":153,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":299,"numEvents":16},{"groupId":"EG001","numAffected":5,"numAtRisk":153,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":299,"numEvents":29},{"groupId":"EG001","numAffected":10,"numAtRisk":153,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":299,"numEvents":76},{"groupId":"EG001","numAffected":14,"numAtRisk":153,"numEvents":20},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":299,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":153,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":299,"numEvents":24},{"groupId":"EG001","numAffected":8,"numAtRisk":153,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":299,"numEvents":25},{"groupId":"EG001","numAffected":10,"numAtRisk":153,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":299,"numEvents":22},{"groupId":"EG001","numAffected":11,"numAtRisk":153,"numEvents":13},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":299,"numEvents":20},{"groupId":"EG001","numAffected":9,"numAtRisk":153,"numEvents":10},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":299,"numEvents":14},{"groupId":"EG001","numAffected":10,"numAtRisk":153,"numEvents":10},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":299,"numEvents":70},{"groupId":"EG001","numAffected":21,"numAtRisk":153,"numEvents":34},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":299,"numEvents":16},{"groupId":"EG001","numAffected":8,"numAtRisk":153,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":299,"numEvents":37},{"groupId":"EG001","numAffected":10,"numAtRisk":153,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":90,"numAtRisk":299,"numEvents":138},{"groupId":"EG001","numAffected":36,"numAtRisk":153,"numEvents":47},{"groupId":"EG002","numAffected":5,"numAtRisk":12,"numEvents":7}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":107,"numAtRisk":299,"numEvents":162},{"groupId":"EG001","numAffected":45,"numAtRisk":153,"numEvents":59},{"groupId":"EG002","numAffected":5,"numAtRisk":12,"numEvents":7}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":299,"numEvents":26},{"groupId":"EG001","numAffected":7,"numAtRisk":153,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bilirubin conjugated increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":299,"numEvents":60},{"groupId":"EG001","numAffected":15,"numAtRisk":153,"numEvents":19},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":83,"numAtRisk":299,"numEvents":142},{"groupId":"EG001","numAffected":40,"numAtRisk":153,"numEvents":48},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":299,"numEvents":13},{"groupId":"EG001","numAffected":4,"numAtRisk":153,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":299,"numEvents":13},{"groupId":"EG001","numAffected":3,"numAtRisk":153,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":299,"numEvents":18},{"groupId":"EG001","numAffected":5,"numAtRisk":153,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":299,"numEvents":62},{"groupId":"EG001","numAffected":23,"numAtRisk":153,"numEvents":25},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":299,"numEvents":25},{"groupId":"EG001","numAffected":5,"numAtRisk":153,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatitis B DNA increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":299,"numEvents":41},{"groupId":"EG001","numAffected":10,"numAtRisk":153,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":299,"numEvents":98},{"groupId":"EG001","numAffected":17,"numAtRisk":153,"numEvents":25},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":299,"numEvents":134},{"groupId":"EG001","numAffected":25,"numAtRisk":153,"numEvents":34},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":299,"numEvents":26},{"groupId":"EG001","numAffected":6,"numAtRisk":153,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":299,"numEvents":128},{"groupId":"EG001","numAffected":21,"numAtRisk":153,"numEvents":33},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":299,"numEvents":50},{"groupId":"EG001","numAffected":14,"numAtRisk":153,"numEvents":18},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":299,"numEvents":28},{"groupId":"EG001","numAffected":2,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":299,"numEvents":19},{"groupId":"EG001","numAffected":2,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":299,"numEvents":46},{"groupId":"EG001","numAffected":13,"numAtRisk":153,"numEvents":14},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":3}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":299,"numEvents":24},{"groupId":"EG001","numAffected":8,"numAtRisk":153,"numEvents":12},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":299,"numEvents":23},{"groupId":"EG001","numAffected":7,"numAtRisk":153,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":299,"numEvents":23},{"groupId":"EG001","numAffected":9,"numAtRisk":153,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoproteinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":299,"numEvents":28},{"groupId":"EG001","numAffected":9,"numAtRisk":153,"numEvents":11},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":299,"numEvents":20},{"groupId":"EG001","numAffected":12,"numAtRisk":153,"numEvents":16},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":299,"numEvents":20},{"groupId":"EG001","numAffected":4,"numAtRisk":153,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hypertonic bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":299,"numEvents":33},{"groupId":"EG001","numAffected":10,"numAtRisk":153,"numEvents":10},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":299,"numEvents":44},{"groupId":"EG001","numAffected":13,"numAtRisk":153,"numEvents":16},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":299,"numEvents":49},{"groupId":"EG001","numAffected":6,"numAtRisk":153,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":299,"numEvents":54},{"groupId":"EG001","numAffected":8,"numAtRisk":153,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":299,"numEvents":22},{"groupId":"EG001","numAffected":7,"numAtRisk":153,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Prinzmetal angina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":299,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":299,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastritis haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastroduodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oesophageal varices haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":299,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":299,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":299,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Biloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cholecystitis chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dilatation intrahepatic duct acquired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dengue fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diarrhoea infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Epiglottitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Epstein-Barr virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Febrile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatitis E"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Laryngopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":299,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":153,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Post procedural infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hand fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":299,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":299,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":299,"numEvents":11},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatitis B DNA increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoproteinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Spinal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":299,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Completed suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Immune-mediated nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Stress urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":299,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":299,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":299,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dermatitis bullous"}],"timeFrame":"All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years."}