{"description":"Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.","eventGroups":[{"description":"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive SOC therapy for an additional 12 months.","id":"EG000","otherNumAffected":105,"otherNumAtRisk":109,"seriousNumAffected":49,"seriousNumAtRisk":109,"title":"Standard of Care Chemotherapy"},{"description":"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.\n\nThe initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.","id":"EG001","otherNumAffected":250,"otherNumAtRisk":267,"seriousNumAffected":165,"seriousNumAtRisk":267,"title":"Blinatumomab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":109},{"groupId":"EG001","numAffected":69,"numAtRisk":267}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":109},{"groupId":"EG001","numAffected":48,"numAtRisk":267}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":109},{"groupId":"EG001","numAffected":51,"numAtRisk":267}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":109},{"groupId":"EG001","numAffected":47,"numAtRisk":267}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":15,"numAtRisk":267}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":109},{"groupId":"EG001","numAffected":18,"numAtRisk":267}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":109},{"groupId":"EG001","numAffected":15,"numAtRisk":267}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":109},{"groupId":"EG001","numAffected":34,"numAtRisk":267}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":109},{"groupId":"EG001","numAffected":58,"numAtRisk":267}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":109},{"groupId":"EG001","numAffected":10,"numAtRisk":267}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":7,"numAtRisk":267}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":109},{"groupId":"EG001","numAffected":51,"numAtRisk":267}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":109},{"groupId":"EG001","numAffected":17,"numAtRisk":267}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":109},{"groupId":"EG001","numAffected":31,"numAtRisk":267}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":109},{"groupId":"EG001","numAffected":19,"numAtRisk":267}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":6,"numAtRisk":267}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":109},{"groupId":"EG001","numAffected":19,"numAtRisk":267}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":109},{"groupId":"EG001","numAffected":34,"numAtRisk":267}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":109},{"groupId":"EG001","numAffected":9,"numAtRisk":267}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":109},{"groupId":"EG001","numAffected":38,"numAtRisk":267}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":16,"numAtRisk":267}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":109},{"groupId":"EG001","numAffected":153,"numAtRisk":267}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":35,"numAtRisk":267}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":16,"numAtRisk":267}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":109},{"groupId":"EG001","numAffected":15,"numAtRisk":267}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":109},{"groupId":"EG001","numAffected":7,"numAtRisk":267}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":5,"numAtRisk":267}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":19,"numAtRisk":267}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":109},{"groupId":"EG001","numAffected":24,"numAtRisk":267}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":109},{"groupId":"EG001","numAffected":15,"numAtRisk":267}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":109},{"groupId":"EG001","numAffected":10,"numAtRisk":267}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":109},{"groupId":"EG001","numAffected":10,"numAtRisk":267}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":109},{"groupId":"EG001","numAffected":17,"numAtRisk":267}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":13,"numAtRisk":267}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":109},{"groupId":"EG001","numAffected":18,"numAtRisk":267}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":109},{"groupId":"EG001","numAffected":20,"numAtRisk":267}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":109},{"groupId":"EG001","numAffected":13,"numAtRisk":267}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":109},{"groupId":"EG001","numAffected":10,"numAtRisk":267}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":109},{"groupId":"EG001","numAffected":45,"numAtRisk":267}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":109},{"groupId":"EG001","numAffected":28,"numAtRisk":267}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":11,"numAtRisk":267}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":109},{"groupId":"EG001","numAffected":16,"numAtRisk":267}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":109},{"groupId":"EG001","numAffected":33,"numAtRisk":267}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":109},{"groupId":"EG001","numAffected":29,"numAtRisk":267}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":19,"numAtRisk":267}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":109},{"groupId":"EG001","numAffected":25,"numAtRisk":267}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":109},{"groupId":"EG001","numAffected":18,"numAtRisk":267}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":109},{"groupId":"EG001","numAffected":77,"numAtRisk":267}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":26,"numAtRisk":267}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":13,"numAtRisk":267}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":109},{"groupId":"EG001","numAffected":28,"numAtRisk":267}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":8,"numAtRisk":267}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":39,"numAtRisk":267}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":109},{"groupId":"EG001","numAffected":15,"numAtRisk":267}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":109},{"groupId":"EG001","numAffected":16,"numAtRisk":267}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":109},{"groupId":"EG001","numAffected":13,"numAtRisk":267}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":109},{"groupId":"EG001","numAffected":7,"numAtRisk":267}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":109},{"groupId":"EG001","numAffected":19,"numAtRisk":267}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":109},{"groupId":"EG001","numAffected":17,"numAtRisk":267}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":109},{"groupId":"EG001","numAffected":32,"numAtRisk":267}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Agranulocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Febrile bone marrow aplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":109},{"groupId":"EG001","numAffected":23,"numAtRisk":267}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Histiocytosis haematophagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Cardiac tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Aplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Gastric haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Gastrointestinal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Gastrointestinal necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hyperthermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Medical device complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":4,"numAtRisk":267}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":16,"numAtRisk":267}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Acute hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Cholestasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Acute graft versus host disease in skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Anaphylactic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":7,"numAtRisk":267}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Graft versus host disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Graft versus host disease in liver"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Abscess fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":6,"numAtRisk":267}],"term":"Bacterial sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Brain abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":4,"numAtRisk":267}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Central nervous system abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Citrobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Citrobacter sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":6,"numAtRisk":267}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Encephalitis enteroviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Enterococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Enterococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Escherichia infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Fungaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Fungal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Fusarium infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Hepatosplenic candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Infection in an immunocompromised host"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Lower respiratory tract infection fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Mastoiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Meningitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Mucormycosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Muscle abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Otitis media acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":10,"numAtRisk":267}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pneumonia pseudomonal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pneumonia respiratory syncytial viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Progressive multifocal leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Pseudomonal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Pseudomonas infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pulmonary mycosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Respiratory syncytial virus bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":109},{"groupId":"EG001","numAffected":13,"numAtRisk":267}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Sepsis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":109},{"groupId":"EG001","numAffected":8,"numAtRisk":267}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Streptococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Systemic candida"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Accidental overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Medication error"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":8,"numAtRisk":267}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Subdural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"CSF cell count abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"White blood cell count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Lactic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Metabolic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Osteitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Acute lymphocytic leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Leukaemic infiltration extramedullary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Leukaemic infiltration pulmonary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":4,"numAtRisk":267}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Generalised tonic-clonic seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Haemorrhagic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hemianopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Hemiplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Intention tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Neurological symptom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Status epilepticus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Completed suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":3,"numAtRisk":267}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Calculus ureteric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Urinary bladder haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":2,"numAtRisk":267}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Catheter placement"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":109},{"groupId":"EG001","numAffected":1,"numAtRisk":267}],"term":"Aortic occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Peripheral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":109},{"groupId":"EG001","numAffected":0,"numAtRisk":267}],"term":"Shock"}],"timeFrame":"From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group."}