{"eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":47,"description":"Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.","id":"EG000","otherNumAffected":45,"otherNumAtRisk":47,"seriousNumAffected":20,"seriousNumAtRisk":47,"title":"HRD Unknown"},{"deathsNumAffected":8,"deathsNumAtRisk":30,"description":"Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \\< 10% were considered HRD-negative.","id":"EG001","otherNumAffected":29,"otherNumAtRisk":30,"seriousNumAffected":14,"seriousNumAtRisk":30,"title":"HRD Negative"},{"deathsNumAffected":7,"deathsNumAtRisk":20,"description":"Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.","id":"EG002","otherNumAffected":19,"otherNumAtRisk":20,"seriousNumAffected":11,"seriousNumAtRisk":20,"title":"HRD Positive"},{"deathsNumAffected":24,"deathsNumAtRisk":97,"description":"All patients","id":"EG003","otherNumAffected":93,"otherNumAtRisk":97,"seriousNumAffected":45,"seriousNumAtRisk":97,"title":"Overall"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":47},{"groupId":"EG001","numAffected":10,"numAtRisk":30},{"groupId":"EG002","numAffected":8,"numAtRisk":20},{"groupId":"EG003","numAffected":34,"numAtRisk":97}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47},{"groupId":"EG001","numAffected":6,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":14,"numAtRisk":97}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":47},{"groupId":"EG001","numAffected":5,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":11,"numAtRisk":97}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Anorectal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":47},{"groupId":"EG001","numAffected":5,"numAtRisk":30},{"groupId":"EG002","numAffected":5,"numAtRisk":20},{"groupId":"EG003","numAffected":20,"numAtRisk":97}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":47},{"groupId":"EG001","numAffected":5,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":12,"numAtRisk":97}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":47},{"groupId":"EG001","numAffected":9,"numAtRisk":30},{"groupId":"EG002","numAffected":6,"numAtRisk":20},{"groupId":"EG003","numAffected":41,"numAtRisk":97}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Swollen tongue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":47},{"groupId":"EG001","numAffected":6,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":22,"numAtRisk":97}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":47},{"groupId":"EG001","numAffected":4,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":17,"numAtRisk":97}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":47},{"groupId":"EG001","numAffected":12,"numAtRisk":30},{"groupId":"EG002","numAffected":7,"numAtRisk":20},{"groupId":"EG003","numAffected":40,"numAtRisk":97}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Localized oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":4,"numAtRisk":20},{"groupId":"EG003","numAffected":8,"numAtRisk":97}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":47},{"groupId":"EG001","numAffected":3,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":7,"numAtRisk":97}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":9,"numAtRisk":97}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Bacterial vaginosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Sialoadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":47},{"groupId":"EG001","numAffected":3,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":10,"numAtRisk":97}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Back injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Joint injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":11,"numAtRisk":97}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47},{"groupId":"EG001","numAffected":5,"numAtRisk":30},{"groupId":"EG002","numAffected":5,"numAtRisk":20},{"groupId":"EG003","numAffected":15,"numAtRisk":97}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":5,"numAtRisk":97}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":47},{"groupId":"EG001","numAffected":11,"numAtRisk":30},{"groupId":"EG002","numAffected":4,"numAtRisk":20},{"groupId":"EG003","numAffected":21,"numAtRisk":97}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47},{"groupId":"EG001","numAffected":3,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":8,"numAtRisk":97}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":47},{"groupId":"EG001","numAffected":7,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":13,"numAtRisk":97}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":47},{"groupId":"EG001","numAffected":7,"numAtRisk":30},{"groupId":"EG002","numAffected":7,"numAtRisk":20},{"groupId":"EG003","numAffected":28,"numAtRisk":97}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47},{"groupId":"EG001","numAffected":4,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":10,"numAtRisk":97}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":47},{"groupId":"EG001","numAffected":3,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":10,"numAtRisk":97}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":7,"numAtRisk":97}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":3,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":7,"numAtRisk":97}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":5,"numAtRisk":97}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Muscle twitching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":6,"numAtRisk":97}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":47},{"groupId":"EG001","numAffected":7,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":16,"numAtRisk":97}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":10,"numAtRisk":97}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":4,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":6,"numAtRisk":97}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47},{"groupId":"EG001","numAffected":6,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":12,"numAtRisk":97}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":2,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":4,"numAtRisk":97}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":3,"numAtRisk":97}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Intermittent claudication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Oropharyngeal pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":5,"numAtRisk":97}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Gastric ulcer perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Hepatocellular injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pubic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":47},{"groupId":"EG001","numAffected":9,"numAtRisk":30},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":18,"numAtRisk":97}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":97}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":1,"numAtRisk":30},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":47},{"groupId":"EG001","numAffected":0,"numAtRisk":30},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":97}],"term":"Hypotension"}],"timeFrame":"Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months."}