{"description":"All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs.\n\nSerious and Other AEs: reported for all randomized participants who received at least one dose of study treatment","eventGroups":[{"deathsNumAffected":8,"deathsNumAtRisk":334,"description":"All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.","id":"EG000","otherNumAffected":331,"otherNumAtRisk":334,"seriousNumAffected":108,"seriousNumAtRisk":334,"title":"Ribociclib + Letrozole"},{"deathsNumAffected":3,"deathsNumAtRisk":334,"description":"All-cause mortality from randomization until 30 days after last dose or start of crossover treatment. Adverse Events from first dose until 30 days after last dose or start of crossover treatment.","id":"EG001","otherNumAffected":317,"otherNumAtRisk":330,"seriousNumAffected":62,"seriousNumAtRisk":330,"title":"Placebo + Letrozole"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment","id":"EG002","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"Crossover to Ribociclib + Letrozole"},{"deathsNumAffected":178,"deathsNumAtRisk":278,"description":"Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Ribociclib + Letrozole (Post-treatment Survival Follow-up)"},{"deathsNumAffected":218,"deathsNumAtRisk":298,"description":"Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period","id":"EG004","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Placebo + Letrozole (Post-treatment Survival Follow-up)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose of crossover treatment). No AEs were collected during this period","id":"EG005","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Survival Follow-up)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":77,"numAtRisk":334},{"groupId":"EG001","numAffected":24,"numAtRisk":330},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":334},{"groupId":"EG001","numAffected":10,"numAtRisk":330},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":334},{"groupId":"EG001","numAffected":7,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":218,"numAtRisk":334},{"groupId":"EG001","numAffected":18,"numAtRisk":330},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":334},{"groupId":"EG001","numAffected":7,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":334},{"groupId":"EG001","numAffected":13,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":334},{"groupId":"EG001","numAffected":7,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":9,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":334},{"groupId":"EG001","numAffected":33,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":334},{"groupId":"EG001","numAffected":21,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":334},{"groupId":"EG001","numAffected":75,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":137,"numAtRisk":334},{"groupId":"EG001","numAffected":88,"numAtRisk":330},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":334},{"groupId":"EG001","numAffected":37,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":334},{"groupId":"EG001","numAffected":25,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":183,"numAtRisk":334},{"groupId":"EG001","numAffected":106,"numAtRisk":330},{"groupId":"EG002","numAffected":3,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":334},{"groupId":"EG001","numAffected":24,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":334},{"groupId":"EG001","numAffected":14,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":115,"numAtRisk":334},{"groupId":"EG001","numAffected":62,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":334},{"groupId":"EG001","numAffected":49,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":4,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":11,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":145,"numAtRisk":334},{"groupId":"EG001","numAffected":119,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":334},{"groupId":"EG001","numAffected":23,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":334},{"groupId":"EG001","numAffected":29,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":334},{"groupId":"EG001","numAffected":41,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":334},{"groupId":"EG001","numAffected":24,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acarodermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":334},{"groupId":"EG001","numAffected":18,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":334},{"groupId":"EG001","numAffected":5,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":334},{"groupId":"EG001","numAffected":18,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":334},{"groupId":"EG001","numAffected":29,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":334},{"groupId":"EG001","numAffected":16,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":334},{"groupId":"EG001","numAffected":43,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":334},{"groupId":"EG001","numAffected":37,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Scar"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":334},{"groupId":"EG001","numAffected":21,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":334},{"groupId":"EG001","numAffected":23,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":334},{"groupId":"EG001","numAffected":21,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":334},{"groupId":"EG001","numAffected":9,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":5,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":78,"numAtRisk":334},{"groupId":"EG001","numAffected":5,"numAtRisk":330},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":334},{"groupId":"EG001","numAffected":16,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":334},{"groupId":"EG001","numAffected":8,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":334},{"groupId":"EG001","numAffected":61,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":334},{"groupId":"EG001","numAffected":10,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":334},{"groupId":"EG001","numAffected":25,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":17,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":334},{"groupId":"EG001","numAffected":6,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":334},{"groupId":"EG001","numAffected":11,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":334},{"groupId":"EG001","numAffected":7,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":135,"numAtRisk":334},{"groupId":"EG001","numAffected":136,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":91,"numAtRisk":334},{"groupId":"EG001","numAffected":76,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":334},{"groupId":"EG001","numAffected":47,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":334},{"groupId":"EG001","numAffected":28,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":334},{"groupId":"EG001","numAffected":27,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":334},{"groupId":"EG001","numAffected":17,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":334},{"groupId":"EG001","numAffected":30,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":334},{"groupId":"EG001","numAffected":21,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":334},{"groupId":"EG001","numAffected":63,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":334},{"groupId":"EG001","numAffected":53,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":334},{"groupId":"EG001","numAffected":14,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":334},{"groupId":"EG001","numAffected":76,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":13,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":8,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":334},{"groupId":"EG001","numAffected":29,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":334},{"groupId":"EG001","numAffected":29,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":334},{"groupId":"EG001","numAffected":49,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":334},{"groupId":"EG001","numAffected":23,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":334},{"groupId":"EG001","numAffected":16,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":334},{"groupId":"EG001","numAffected":83,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":334},{"groupId":"EG001","numAffected":44,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":334},{"groupId":"EG001","numAffected":10,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":334},{"groupId":"EG001","numAffected":21,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":119,"numAtRisk":334},{"groupId":"EG001","numAffected":55,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":334},{"groupId":"EG001","numAffected":12,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":334},{"groupId":"EG001","numAffected":6,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":334},{"groupId":"EG001","numAffected":27,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":68,"numAtRisk":334},{"groupId":"EG001","numAffected":33,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vitiligo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":334},{"groupId":"EG001","numAffected":88,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":334},{"groupId":"EG001","numAffected":69,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cor pulmonale"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal incarcerated hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Duodenal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Duodenal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gastric antral vascular ectasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gastrointestinal wall thickening"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Impaired gastric emptying"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Intestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Drug-induced liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatic cytolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abscess jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Atypical pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bronchitis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Encephalitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Respiratory tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Retroperitoneal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gastrointestinal procedural complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Inflammation of wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Radius fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sternal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Thoracic vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood thyroid stimulating hormone decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"International normalised ratio increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Waist circumference increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Haemarthrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteonecrosis of jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bladder cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bowen's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Laryngeal squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Malignant melanoma in situ"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Meningioma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Non-small cell lung cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Oncocytoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Uterine leiomyoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Intracranial pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Toxic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Major depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Renal colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bronchial haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":334},{"groupId":"EG001","numAffected":4,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":334},{"groupId":"EG001","numAffected":2,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Actinic keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Peripheral arterial occlusive disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Peripheral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Subclavian vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":330},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Superior vena cava syndrome"}],"timeFrame":"All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months"}