{"description":"Safety analysis was performed on AT population including all participants who took part of any dose of the study medication.","eventGroups":[{"deathsNumAffected":17,"deathsNumAtRisk":533,"description":"Participants received TAS-102 orally with a starting dose of 35 mg/m\\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.","id":"EG000","otherNumAffected":506,"otherNumAtRisk":533,"seriousNumAffected":158,"seriousNumAtRisk":533,"title":"TAS-102"},{"deathsNumAffected":30,"deathsNumAtRisk":265,"description":"Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.","id":"EG001","otherNumAffected":227,"otherNumAtRisk":265,"seriousNumAffected":89,"seriousNumAtRisk":265,"title":"Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":205,"numAtRisk":533,"numEvents":265},{"groupId":"EG001","numAffected":22,"numAtRisk":265,"numEvents":24}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":533,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":152,"numAtRisk":533,"numEvents":327},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":533,"numEvents":58},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":533,"numEvents":83},{"groupId":"EG001","numAffected":32,"numAtRisk":265,"numEvents":32}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":533,"numEvents":40},{"groupId":"EG001","numAffected":12,"numAtRisk":265,"numEvents":15}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":81,"numAtRisk":533,"numEvents":87},{"groupId":"EG001","numAffected":40,"numAtRisk":265,"numEvents":42}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":167,"numAtRisk":533,"numEvents":240},{"groupId":"EG001","numAffected":33,"numAtRisk":265,"numEvents":39}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":256,"numAtRisk":533,"numEvents":410},{"groupId":"EG001","numAffected":63,"numAtRisk":265,"numEvents":73}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":533,"numEvents":54},{"groupId":"EG001","numAffected":16,"numAtRisk":265,"numEvents":17}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":142,"numAtRisk":533,"numEvents":217},{"groupId":"EG001","numAffected":38,"numAtRisk":265,"numEvents":57}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":96,"numAtRisk":533,"numEvents":116},{"groupId":"EG001","numAffected":29,"numAtRisk":265,"numEvents":29}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":185,"numAtRisk":533,"numEvents":227},{"groupId":"EG001","numAffected":60,"numAtRisk":265,"numEvents":64}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":533,"numEvents":37},{"groupId":"EG001","numAffected":12,"numAtRisk":265,"numEvents":13}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":533,"numEvents":57},{"groupId":"EG001","numAffected":27,"numAtRisk":265,"numEvents":27}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":93,"numAtRisk":533,"numEvents":115},{"groupId":"EG001","numAffected":36,"numAtRisk":265,"numEvents":40}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":533,"numEvents":31},{"groupId":"EG001","numAffected":14,"numAtRisk":265,"numEvents":14}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":533,"numEvents":33},{"groupId":"EG001","numAffected":21,"numAtRisk":265,"numEvents":22}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":533,"numEvents":48},{"groupId":"EG001","numAffected":26,"numAtRisk":265,"numEvents":26}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":533,"numEvents":59},{"groupId":"EG001","numAffected":18,"numAtRisk":265,"numEvents":19}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":148,"numAtRisk":533,"numEvents":417},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":12}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":81,"numAtRisk":533,"numEvents":172},{"groupId":"EG001","numAffected":6,"numAtRisk":265,"numEvents":6}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":533,"numEvents":44},{"groupId":"EG001","numAffected":27,"numAtRisk":265,"numEvents":27}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":146,"numAtRisk":533,"numEvents":354},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":206,"numAtRisk":533,"numEvents":276},{"groupId":"EG001","numAffected":76,"numAtRisk":265,"numEvents":81}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":533,"numEvents":16},{"groupId":"EG001","numAffected":14,"numAtRisk":265,"numEvents":14}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":533,"numEvents":41},{"groupId":"EG001","numAffected":18,"numAtRisk":265,"numEvents":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":533,"numEvents":30},{"groupId":"EG001","numAffected":20,"numAtRisk":265,"numEvents":21}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":533,"numEvents":42},{"groupId":"EG001","numAffected":6,"numAtRisk":265,"numEvents":6}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":533,"numEvents":32},{"groupId":"EG001","numAffected":13,"numAtRisk":265,"numEvents":14}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":533,"numEvents":24},{"groupId":"EG001","numAffected":25,"numAtRisk":265,"numEvents":25}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":533,"numEvents":61},{"groupId":"EG001","numAffected":30,"numAtRisk":265,"numEvents":32}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":533,"numEvents":59},{"groupId":"EG001","numAffected":28,"numAtRisk":265,"numEvents":28}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":533,"numEvents":36},{"groupId":"EG001","numAffected":3,"numAtRisk":265,"numEvents":3}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":533,"numEvents":23},{"groupId":"EG001","numAffected":14,"numAtRisk":265,"numEvents":14}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":533,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":533,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":533,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Cardiac tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Cardio-Respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":533,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":265,"numEvents":5}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":265,"numEvents":3}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":533,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":265,"numEvents":5}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Mechanical ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Rectal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Rectal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Sigmoiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":533,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":3}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":533,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":533,"numEvents":15},{"groupId":"EG001","numAffected":11,"numAtRisk":265,"numEvents":11}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Hyperpyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Multi-Organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":533,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Cholangitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Cholestasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":265,"numEvents":6}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Hepatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":533,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Bronchopneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Enteritis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Escherichia urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Kidney infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Peritonitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pneumonia klebsiella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pneumonia staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Streptococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":265,"numEvents":4}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Extradural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":533,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Medication error"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":533,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Tracheal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":265,"numEvents":5}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":3}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":265,"numEvents":2}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Lymphangiosis carcinomatosa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Malignant ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Metastases to peritoneum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Metastasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":265,"numEvents":3}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Brain compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Epiduritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Monoparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Nerve root compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Neurological decompensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Psychomotor skills impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Postrenal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":533,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":533,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":265,"numEvents":6}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":533,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":265,"numEvents":3}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Pulmonary congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":533,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":265,"numEvents":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":533,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":533,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":265,"numEvents":1}],"term":"Intra-Abdominal haematoma"}],"timeFrame":"From the time of signing the informed consent form until the period of participant follow up (30 days following the administration of last dose of study medication or until initiation of new anti-tumor therapy, whichever was earlier, up to 85 weeks approximately (duration of study))."}