{"eventGroups":[{"description":"Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)","id":"EG000","otherNumAffected":280,"otherNumAtRisk":280,"seriousNumAffected":122,"seriousNumAtRisk":280,"title":"Everolimus + Trastuzumab + Vinorelbine"},{"description":"Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)","id":"EG001","otherNumAffected":280,"otherNumAtRisk":282,"seriousNumAffected":58,"seriousNumAtRisk":282,"title":"Placebo + Trastuzumab + Vinorelbine"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":137,"numAtRisk":280},{"groupId":"EG001","numAffected":85,"numAtRisk":282}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":280},{"groupId":"EG001","numAffected":7,"numAtRisk":282}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":126,"numAtRisk":280},{"groupId":"EG001","numAffected":105,"numAtRisk":282}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":226,"numAtRisk":280},{"groupId":"EG001","numAffected":196,"numAtRisk":282}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":280},{"groupId":"EG001","numAffected":6,"numAtRisk":282}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":280},{"groupId":"EG001","numAffected":52,"numAtRisk":282}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":280},{"groupId":"EG001","numAffected":40,"numAtRisk":282}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":280},{"groupId":"EG001","numAffected":88,"numAtRisk":282}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":108,"numAtRisk":280},{"groupId":"EG001","numAffected":88,"numAtRisk":282}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":280},{"groupId":"EG001","numAffected":7,"numAtRisk":282}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":280},{"groupId":"EG001","numAffected":25,"numAtRisk":282}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":280},{"groupId":"EG001","numAffected":6,"numAtRisk":282}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":280},{"groupId":"EG001","numAffected":105,"numAtRisk":282}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":174,"numAtRisk":280},{"groupId":"EG001","numAffected":78,"numAtRisk":282}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":280},{"groupId":"EG001","numAffected":59,"numAtRisk":282}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":280},{"groupId":"EG001","numAffected":57,"numAtRisk":282}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":280},{"groupId":"EG001","numAffected":18,"numAtRisk":282}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":280},{"groupId":"EG001","numAffected":119,"numAtRisk":282}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":280},{"groupId":"EG001","numAffected":20,"numAtRisk":282}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":280},{"groupId":"EG001","numAffected":23,"numAtRisk":282}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":280},{"groupId":"EG001","numAffected":20,"numAtRisk":282}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":107,"numAtRisk":280},{"groupId":"EG001","numAffected":65,"numAtRisk":282}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":280},{"groupId":"EG001","numAffected":29,"numAtRisk":282}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":280},{"groupId":"EG001","numAffected":26,"numAtRisk":282}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":280},{"groupId":"EG001","numAffected":18,"numAtRisk":282}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":280},{"groupId":"EG001","numAffected":26,"numAtRisk":282}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":280},{"groupId":"EG001","numAffected":22,"numAtRisk":282}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":280},{"groupId":"EG001","numAffected":5,"numAtRisk":282}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":280},{"groupId":"EG001","numAffected":23,"numAtRisk":282}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":280},{"groupId":"EG001","numAffected":18,"numAtRisk":282}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":280},{"groupId":"EG001","numAffected":8,"numAtRisk":282}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":83,"numAtRisk":280},{"groupId":"EG001","numAffected":47,"numAtRisk":282}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":280},{"groupId":"EG001","numAffected":23,"numAtRisk":282}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":94,"numAtRisk":280},{"groupId":"EG001","numAffected":49,"numAtRisk":282}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":280},{"groupId":"EG001","numAffected":12,"numAtRisk":282}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":280},{"groupId":"EG001","numAffected":15,"numAtRisk":282}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":280},{"groupId":"EG001","numAffected":9,"numAtRisk":282}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":280},{"groupId":"EG001","numAffected":19,"numAtRisk":282}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":280},{"groupId":"EG001","numAffected":36,"numAtRisk":282}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":280},{"groupId":"EG001","numAffected":46,"numAtRisk":282}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":280},{"groupId":"EG001","numAffected":24,"numAtRisk":282}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":280},{"groupId":"EG001","numAffected":47,"numAtRisk":282}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":280},{"groupId":"EG001","numAffected":12,"numAtRisk":282}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":280},{"groupId":"EG001","numAffected":14,"numAtRisk":282}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":280},{"groupId":"EG001","numAffected":31,"numAtRisk":282}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":280},{"groupId":"EG001","numAffected":44,"numAtRisk":282}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":280},{"groupId":"EG001","numAffected":24,"numAtRisk":282}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":280},{"groupId":"EG001","numAffected":17,"numAtRisk":282}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":280},{"groupId":"EG001","numAffected":62,"numAtRisk":282}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":280},{"groupId":"EG001","numAffected":7,"numAtRisk":282}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":280},{"groupId":"EG001","numAffected":41,"numAtRisk":282}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":280},{"groupId":"EG001","numAffected":21,"numAtRisk":282}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":280},{"groupId":"EG001","numAffected":17,"numAtRisk":282}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":280},{"groupId":"EG001","numAffected":18,"numAtRisk":282}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":280},{"groupId":"EG001","numAffected":27,"numAtRisk":282}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":280},{"groupId":"EG001","numAffected":55,"numAtRisk":282}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":280},{"groupId":"EG001","numAffected":40,"numAtRisk":282}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":280},{"groupId":"EG001","numAffected":38,"numAtRisk":282}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":280},{"groupId":"EG001","numAffected":27,"numAtRisk":282}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":280},{"groupId":"EG001","numAffected":9,"numAtRisk":282}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":280},{"groupId":"EG001","numAffected":14,"numAtRisk":282}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":280},{"groupId":"EG001","numAffected":29,"numAtRisk":282}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":280},{"groupId":"EG001","numAffected":29,"numAtRisk":282}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":280},{"groupId":"EG001","numAffected":54,"numAtRisk":282}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":280},{"groupId":"EG001","numAffected":16,"numAtRisk":282}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":280},{"groupId":"EG001","numAffected":10,"numAtRisk":282}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":280},{"groupId":"EG001","numAffected":18,"numAtRisk":282}],"term":"Phlebitis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Agranulocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":280},{"groupId":"EG001","numAffected":4,"numAtRisk":282}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Immune thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":280},{"groupId":"EG001","numAffected":3,"numAtRisk":282}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Cataract subcapsular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Gastrointestinal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Neutropenic colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Device dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hyperpyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hyperthermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":280},{"groupId":"EG001","numAffected":5,"numAtRisk":282}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hepatic mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Hepatocellular injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Abscess jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Aspergillus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Escherichia urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Furuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Gastroenteritis clostridial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Klebsiella bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Lobar pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Neutropenic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Peritonsillar abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pneumocystis jirovecii infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pseudomonal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Fractured sacrum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hand fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pelvic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Thoracic vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Paraneoplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Thyroid cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Disturbance in attention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":3,"numAtRisk":282}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Neurological symptom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Suicide attempt"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Ovarian cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Uterine haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":3,"numAtRisk":282}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Haemothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":5,"numAtRisk":282}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":280},{"groupId":"EG001","numAffected":3,"numAtRisk":282}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Pulmonary arterial hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":280},{"groupId":"EG001","numAffected":5,"numAtRisk":282}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":3,"numAtRisk":282}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Tachypnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":0,"numAtRisk":282}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":280},{"groupId":"EG001","numAffected":2,"numAtRisk":282}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA V18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":280},{"groupId":"EG001","numAffected":1,"numAtRisk":282}],"term":"Thrombosis"}]}