{"eventGroups":[{"deathsNumAffected":393,"deathsNumAtRisk":443,"description":"Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\\^2), paclitaxel 175 mg/m\\^2, or docetaxel 75 mg/m\\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.","id":"EG000","otherNumAffected":417,"otherNumAtRisk":443,"seriousNumAffected":189,"seriousNumAtRisk":443,"title":"Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)"},{"deathsNumAffected":379,"deathsNumAtRisk":459,"description":"Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.","id":"EG001","otherNumAffected":413,"otherNumAtRisk":459,"seriousNumAffected":192,"seriousNumAtRisk":459,"title":"Atezolizumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":443,"numEvents":142},{"groupId":"EG001","numAffected":90,"numAtRisk":459,"numEvents":94}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":443,"numEvents":75},{"groupId":"EG001","numAffected":5,"numAtRisk":459,"numEvents":6}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":443,"numEvents":63},{"groupId":"EG001","numAffected":52,"numAtRisk":459,"numEvents":60}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":443,"numEvents":32},{"groupId":"EG001","numAffected":23,"numAtRisk":459,"numEvents":23}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":163,"numAtRisk":443,"numEvents":221},{"groupId":"EG001","numAffected":131,"numAtRisk":459,"numEvents":147}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":94,"numAtRisk":443,"numEvents":115},{"groupId":"EG001","numAffected":97,"numAtRisk":459,"numEvents":145}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":443,"numEvents":8},{"groupId":"EG001","numAffected":30,"numAtRisk":459,"numEvents":36}],"term":"Dry Mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":137,"numAtRisk":443,"numEvents":171},{"groupId":"EG001","numAffected":106,"numAtRisk":459,"numEvents":124}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":443,"numEvents":41},{"groupId":"EG001","numAffected":13,"numAtRisk":459,"numEvents":16}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":81,"numAtRisk":443,"numEvents":108},{"groupId":"EG001","numAffected":55,"numAtRisk":459,"numEvents":67}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":107,"numAtRisk":443,"numEvents":144},{"groupId":"EG001","numAffected":92,"numAtRisk":459,"numEvents":108}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":443,"numEvents":162},{"groupId":"EG001","numAffected":129,"numAtRisk":459,"numEvents":153}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":443,"numEvents":64},{"groupId":"EG001","numAffected":27,"numAtRisk":459,"numEvents":30}],"term":"Mucosal Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":443,"numEvents":43},{"groupId":"EG001","numAffected":52,"numAtRisk":459,"numEvents":59}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":443,"numEvents":34},{"groupId":"EG001","numAffected":24,"numAtRisk":459,"numEvents":24}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":443,"numEvents":76},{"groupId":"EG001","numAffected":93,"numAtRisk":459,"numEvents":128}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":443,"numEvents":15},{"groupId":"EG001","numAffected":27,"numAtRisk":459,"numEvents":43}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":443,"numEvents":76},{"groupId":"EG001","numAffected":84,"numAtRisk":459,"numEvents":141}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":443,"numEvents":12},{"groupId":"EG001","numAffected":36,"numAtRisk":459,"numEvents":38}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":443,"numEvents":49},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":443,"numEvents":46},{"groupId":"EG001","numAffected":47,"numAtRisk":459,"numEvents":47}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":113,"numAtRisk":443,"numEvents":136},{"groupId":"EG001","numAffected":135,"numAtRisk":459,"numEvents":147}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":443,"numEvents":26},{"groupId":"EG001","numAffected":16,"numAtRisk":459,"numEvents":17}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":443,"numEvents":79},{"groupId":"EG001","numAffected":47,"numAtRisk":459,"numEvents":66}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":443,"numEvents":53},{"groupId":"EG001","numAffected":80,"numAtRisk":459,"numEvents":95}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":443,"numEvents":28},{"groupId":"EG001","numAffected":24,"numAtRisk":459,"numEvents":27}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":443,"numEvents":68},{"groupId":"EG001","numAffected":25,"numAtRisk":459,"numEvents":27}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":443,"numEvents":55},{"groupId":"EG001","numAffected":37,"numAtRisk":459,"numEvents":46}],"term":"Pain in Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":443,"numEvents":32},{"groupId":"EG001","numAffected":29,"numAtRisk":459,"numEvents":29}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":443,"numEvents":27},{"groupId":"EG001","numAffected":12,"numAtRisk":459,"numEvents":14}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":443,"numEvents":35},{"groupId":"EG001","numAffected":38,"numAtRisk":459,"numEvents":44}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":443,"numEvents":67},{"groupId":"EG001","numAffected":8,"numAtRisk":459,"numEvents":9}],"term":"Neuropathy Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":443,"numEvents":32},{"groupId":"EG001","numAffected":18,"numAtRisk":459,"numEvents":18}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":443,"numEvents":43},{"groupId":"EG001","numAffected":6,"numAtRisk":459,"numEvents":7}],"term":"Peripheral Sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":443,"numEvents":24},{"groupId":"EG001","numAffected":27,"numAtRisk":459,"numEvents":27}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":443,"numEvents":42},{"groupId":"EG001","numAffected":45,"numAtRisk":459,"numEvents":48}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":443,"numEvents":32},{"groupId":"EG001","numAffected":45,"numAtRisk":459,"numEvents":60}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":443,"numEvents":36},{"groupId":"EG001","numAffected":59,"numAtRisk":459,"numEvents":69}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":443,"numEvents":50},{"groupId":"EG001","numAffected":62,"numAtRisk":459,"numEvents":70}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":125,"numAtRisk":443,"numEvents":127},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":443,"numEvents":27},{"groupId":"EG001","numAffected":64,"numAtRisk":459,"numEvents":86}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":443,"numEvents":37},{"groupId":"EG001","numAffected":54,"numAtRisk":459,"numEvents":72}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":443,"numEvents":22},{"groupId":"EG001","numAffected":23,"numAtRisk":459,"numEvents":24}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":443,"numEvents":5},{"groupId":"EG001","numAffected":9,"numAtRisk":459,"numEvents":9}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Bone Marrow Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":443,"numEvents":25},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":443,"numEvents":15},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Acute Coronary Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Acute Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Angina Pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Atrioventricular Block"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Cardiac Arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Cardio-Respiratory Arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Pericardial Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":2}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Macular Fibrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Papilloedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Visual Impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":443,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":459,"numEvents":5}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Abdominal Pain Lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Anal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Autoimmune Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Colitis Ulcerative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":443,"numEvents":23},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":459,"numEvents":6}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Duodenal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Enterovesical Fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Gastric Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Gastrointestinal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Ileal Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":443,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":2}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Inguinal Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Intestinal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Intestinal Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Jejunal Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Large Intestinal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Rectal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Small Intestinal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":3}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":5}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":443,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":4}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Influenza Like Illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Injection Site Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Multiple Organ Dysfunction Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Peripheral Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":443,"numEvents":5},{"groupId":"EG001","numAffected":17,"numAtRisk":459,"numEvents":18}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Strangulated Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":5}],"term":"Autoimmune Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Biliary Dilation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hepatocellular Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Portal Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Drug Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Arthritis Infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Bacterial Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Device Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Enterococcal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Enterococcal Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":3}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Escherichia Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Escherichia Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Escherichia Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Kidney Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Klebsiella Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Lower Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Meningoencephalitis Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Neutropenic Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Neutropenic Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Ophthalmic Herpes Zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":443,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":5}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":443,"numEvents":16},{"groupId":"EG001","numAffected":8,"numAtRisk":459,"numEvents":8}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Septic Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Spinal Cord Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Staphylococcal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Toxic Shock Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":443,"numEvents":17},{"groupId":"EG001","numAffected":21,"numAtRisk":459,"numEvents":25}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Urinary Tract Infection Bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":443,"numEvents":12},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Compression Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Femoral Neck Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Infusion Related Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Lower Limb Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Lumbar Vertebral Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Spinal Compression Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Stoma Site Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Toxicity to Various Agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Urostomy Complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Alanine Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Liver Function Test Abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Transaminases Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"White Blood Cell Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Diabetes Mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Diabetic Ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Failure to Thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":2}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":4}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":459,"numEvents":6}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Groin Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Pain in Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Pathological Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Colon Cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Mantle Cell Lymphoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Neoplasm Malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Tumor Associated Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Brain Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Ischaemic Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Radiculopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Sciatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Transient Ischaemic Attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Device Dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":2}],"term":"Device Occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Completed Suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Confusional State"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":443,"numEvents":6},{"groupId":"EG001","numAffected":11,"numAtRisk":459,"numEvents":12}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Anuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Bladder Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Bladder Tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":443,"numEvents":9},{"groupId":"EG001","numAffected":10,"numAtRisk":459,"numEvents":19}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":459,"numEvents":3}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Postrenal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":443,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":4}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Renal Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Urethral Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Urinary Bladder Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":459,"numEvents":6}],"term":"Urinary Retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Urinary Tract Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Urinary Tract Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Urinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Vaginal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":459,"numEvents":7}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Pneumonia Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":4}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Productive Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":4}],"term":"Pulmonary Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Respiratory Distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Toxic Epidermal Necrolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":459,"numEvents":4}],"term":"Deep Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":443,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":443,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Thrombophlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Enterocolitis Haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Gastrointestinal Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":459,"numEvents":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Unevaluable Event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Escherichia Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Pyonephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":443,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Vascular Device Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Skin Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Gamma-Glutamyltransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Gouty Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Cancer Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Gastric Cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Parkinson's Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Genital Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":443,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":459,"numEvents":0}],"term":"Internal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":443,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":459,"numEvents":1}],"term":"Adrenal Insufficiency"}],"timeFrame":"From the first study drug to the data cutoff date: 8 Nov 2018 (up to 46 months)"}