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shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Haemophagocytic lymphohistiocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Enterobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Epiglottitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Tracheal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":65}],"term":"Peripheral ischaemia"}],"timeFrame":"From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months."}