{"description":"All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":132,"description":"Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days).","id":"EG000","otherNumAffected":127,"otherNumAtRisk":132,"seriousNumAffected":24,"seriousNumAtRisk":132,"title":"MDS or CMML: IV Decitabine"},{"deathsNumAffected":56,"deathsNumAtRisk":130,"description":"Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.","id":"EG001","otherNumAffected":130,"otherNumAtRisk":130,"seriousNumAffected":81,"seriousNumAtRisk":130,"title":"MDS or CMML: ASTX727"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants with MDS or CMML were enrolled in the study but did not receive any study treatment.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"MDS or CMML: Not Treated"},{"deathsNumAffected":5,"deathsNumAtRisk":78,"description":"Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycles 1 or 2.","id":"EG003","otherNumAffected":70,"otherNumAtRisk":78,"seriousNumAffected":19,"seriousNumAtRisk":78,"title":"AML: IV Decitabine"},{"deathsNumAffected":61,"deathsNumAtRisk":80,"description":"Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.","id":"EG004","otherNumAffected":76,"otherNumAtRisk":80,"seriousNumAffected":65,"seriousNumAtRisk":80,"title":"AML: ASTX727"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants with AML were enrolled in the study but did not receive any study treatment.","id":"EG005","otherNumAffected":0,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"AML: Not Treated"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":132},{"groupId":"EG001","numAffected":90,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":30,"numAtRisk":78},{"groupId":"EG004","numAffected":47,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":132},{"groupId":"EG001","numAffected":79,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":8,"numAtRisk":78},{"groupId":"EG004","numAffected":27,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":132},{"groupId":"EG001","numAffected":72,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":21,"numAtRisk":78},{"groupId":"EG004","numAffected":41,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":132},{"groupId":"EG001","numAffected":37,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":9,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":132},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":7,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Conjunctival Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":132},{"groupId":"EG001","numAffected":64,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":8,"numAtRisk":78},{"groupId":"EG004","numAffected":15,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":132},{"groupId":"EG001","numAffected":63,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":17,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":132},{"groupId":"EG001","numAffected":54,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":17,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":26,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":78},{"groupId":"EG004","numAffected":10,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":132},{"groupId":"EG001","numAffected":23,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":132},{"groupId":"EG001","numAffected":20,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":132},{"groupId":"EG001","numAffected":68,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":9,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":132},{"groupId":"EG001","numAffected":36,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":8,"numAtRisk":78},{"groupId":"EG004","numAffected":16,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":132},{"groupId":"EG001","numAffected":29,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":6,"numAtRisk":78},{"groupId":"EG004","numAffected":20,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":132},{"groupId":"EG001","numAffected":27,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":6,"numAtRisk":78},{"groupId":"EG004","numAffected":18,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":13,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":132},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Peripheral Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":16,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":16,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":8,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":11,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":5,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Corona Virus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":24,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":16,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":8,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Procedural Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132},{"groupId":"EG001","numAffected":20,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Alanine Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":17,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":14,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":5,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":11,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Blood Alkaline Phosphatase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":78},{"groupId":"EG004","numAffected":7,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"C-Reactive Protein Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132},{"groupId":"EG001","numAffected":43,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":5,"numAtRisk":78},{"groupId":"EG004","numAffected":12,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132},{"groupId":"EG001","numAffected":27,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":15,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":14,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":14,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":12,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":132},{"groupId":"EG001","numAffected":32,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":8,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":132},{"groupId":"EG001","numAffected":26,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":9,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132},{"groupId":"EG001","numAffected":21,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":132},{"groupId":"EG001","numAffected":18,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":13,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Muscle Spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":11,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Musculoskeletal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Neck Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":132},{"groupId":"EG001","numAffected":50,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":132},{"groupId":"EG001","numAffected":42,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":8,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":19,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":9,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":5,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":132},{"groupId":"EG001","numAffected":45,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":132},{"groupId":"EG001","numAffected":40,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":9,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":132},{"groupId":"EG001","numAffected":26,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Oropharyngeal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":132},{"groupId":"EG001","numAffected":16,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":7,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":15,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Nasal Congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dyspnoea Exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rhinitis Allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":6,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":17,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rash Maculo-Papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":132},{"groupId":"EG001","numAffected":16,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":13,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":132},{"groupId":"EG001","numAffected":12,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Skin Lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Night Sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":132},{"groupId":"EG001","numAffected":16,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":78},{"groupId":"EG004","numAffected":8,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":3,"numAtRisk":78},{"groupId":"EG004","numAffected":9,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dry Mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Tongue Ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Oral Herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Confusional State"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":132},{"groupId":"EG001","numAffected":33,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":21,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Aplasia pure red cell"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haematotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Lymphadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cardiac Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cardiac Failure Congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Proctitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Gastrointestinal Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haemorrhoidal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Intestinal Ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pancreatitis Chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":3,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Multiple Organ Dysfunction Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Mucosal Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Polyserositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":1,"numAtRisk":2}],"term":"Sudden Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Jaundice Cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":132},{"groupId":"EG001","numAffected":17,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":4,"numAtRisk":78},{"groupId":"EG004","numAffected":16,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":3,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132},{"groupId":"EG001","numAffected":5,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":4,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Colonic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Enterobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Gastroenteritis Escherichia coli"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Peritonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumonia cytomegaloviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pseudomonal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Sinusitis fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":3,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Vascular device infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":5,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":3,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":3,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Neutropenic Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":2,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Escherichia Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumonia Fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Abdominal Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Anal Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Anorectal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cellulitis Staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cholecystitis Infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Clostridium Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Corona Virus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Enterococcal Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Escherichia Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Klebsiella Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Liver Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumonia Necrotising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumonia Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Post Procedural Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Sinusitis Aspergillus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Post procedural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Ankle Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Exposure To Communicable Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Multiple Fractures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Subdural Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Influenza A virus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"C-Reactive Protein Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Soft tissue necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Adenocarcinoma gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pancreatic carcinoma metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Refractory cytopenia with unilineage dysplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Chronic Lymphocytic Leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":2,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Cerebrovascular Accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Ischaemic Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Suicide attempt"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Confusional State"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":3,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Respiratory Distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypersensitivity vasculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Pyoderma gangrenosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Embolism arterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":0,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Extravasation Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":1,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":132},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":5},{"groupId":"EG003","numAffected":0,"numAtRisk":78},{"groupId":"EG004","numAffected":1,"numAtRisk":80},{"groupId":"EG005","numAffected":0,"numAtRisk":2}],"term":"Loss Of Personal Independence In Daily Activities"}],"timeFrame":"MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years"}