{"eventGroups":[{"description":"SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"SyB L-0501 + Prednisolone"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Anaemia"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Febrile neutropenia"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Abdominal distension"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Constipation"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Diarrhoea"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Proctalgia"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Stomatitis"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Vomiting"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Malaise"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Oedema"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Oedema peripheral"},{"organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pyrexia"},{"organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hepatic function abnormal"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Infection"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pharyngitis"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Upper respiratory tract infection"},{"organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Excoriation"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Alanine aminotransferase increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood albumin decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Blood creatinine increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Blood lactate dehydrogenase increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Blood potassium increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood sodium decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood urea increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood uric acid decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood uric acid increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"C-reactive protein increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"CD4 lymphocytes decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Gamma-glutamyltransferase increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Haemoglobin decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":5}],"term":"Lymphocyte count decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":5}],"term":"Neutrophil count decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Neutrophil count increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":5}],"term":"Platelet count decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Protein total decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Weight increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":5}],"term":"White blood cell count decreased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"White blood cell count increased"},{"organSystem":"Investigations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Blood alkaline phosphatase increased"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Diabetes mellitus"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypokalaemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Tumour lysis syndrome"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Decreased appetite"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dyspnoea"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Rhinorrhoea"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dry skin"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Erythema"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Rash"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Scab"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Toxic skin eruption"},{"organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Circulatory collapse"}],"seriousEvents":[{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Pneumonia"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Septic shock"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Pneumonia bacterial"},{"organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Acute respiratory distress syndrome"}],"timeFrame":"Up to 2 years"}