{"description":"Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":1,"description":"28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"AMG 420 200 µg/Day"},{"deathsNumAffected":6,"deathsNumAtRisk":12,"description":"28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation","id":"EG001","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":10,"seriousNumAtRisk":12,"title":"AMG 420 400 µg/Day"},{"deathsNumAffected":4,"deathsNumAtRisk":10,"description":"28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation","id":"EG002","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":8,"seriousNumAtRisk":10,"title":"AMG 420 600 µg/Day"},{"deathsNumAffected":11,"deathsNumAtRisk":23,"description":"AMG 420 Total","id":"EG003","otherNumAffected":23,"otherNumAtRisk":23,"seriousNumAffected":19,"seriousNumAtRisk":23,"title":"Total"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":4,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":8,"numAtRisk":23}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hyperfibrinogenaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Leukocyte vacuolisation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Neutrophilia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Conjunctival haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":5,"numAtRisk":10},{"groupId":"EG003","numAffected":8,"numAtRisk":23}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":23}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Lip dry"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":5,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":8,"numAtRisk":23}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":5,"numAtRisk":12},{"groupId":"EG002","numAffected":6,"numAtRisk":10},{"groupId":"EG003","numAffected":11,"numAtRisk":23}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypothermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":6,"numAtRisk":12},{"groupId":"EG002","numAffected":6,"numAtRisk":10},{"groupId":"EG003","numAffected":12,"numAtRisk":23}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":9,"numAtRisk":12},{"groupId":"EG002","numAffected":7,"numAtRisk":10},{"groupId":"EG003","numAffected":17,"numAtRisk":23}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Metapneumovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":4,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Urinary tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Fibula fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Sternal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Blood creatine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Blood fibrinogen increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Carbon dioxide decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Electrocardiogram T wave abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Fibrin D dimer increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Immature granulocyte count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Nitrite urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Protein total increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":23}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Gout"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":6,"numAtRisk":23}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Iron deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":23}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":23}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Rheumatoid arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Synovial cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":23}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":8,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":12,"numAtRisk":23}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Sinus headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Nervousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Substance abuse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":23}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":23}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Respiratory alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":5,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":8,"numAtRisk":23}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Infusion site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":23}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":23}],"term":"Plasma cell myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Plasmacytoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":23}],"term":"Hypotension"}],"timeFrame":"Up to approximately 3 years"}