{"description":"There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.","eventGroups":[{"description":"TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)","id":"EG000","otherNumAffected":6,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"TG-0054 (2.24 mg/kg)"},{"description":"TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)","id":"EG001","otherNumAffected":8,"otherNumAtRisk":12,"seriousNumAffected":6,"seriousNumAtRisk":12,"title":"TG-0054 (3.14 mg/kg)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably related to study drug.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably not related to study drug.","organSystem":"Investigations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"ABNORMAL DATA OF INCREASE BILIRUBIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Possible related to study drug.","organSystem":"Investigations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably not related to study drug.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"CHEST TIGHTNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"CLONIC OF RIGHT KNEE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. 1 probably related and 1 definitely related.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"DIARRHEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. 2 definitely not related and 1 possible related.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"DRY COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"ECCHYMOSIS OVER FEMORAL PUNCTURE SITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"EMESIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Possible related to study drug.","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"FEVER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. All possible related to study drug.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"HYPERCALCEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"HYPOCALCEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"HYPOCALCIUM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably not related to study drug.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"HYPOKALEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Possible related to study drug.","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"HYPOTENSION BP 82/51MMHG"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Possible related to study drug.","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"HYPOVOLEMIC HYPOTENSION BP 78/56MMHG"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably not related to study drug.","organSystem":"Investigations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"INCREASE ALANINE AMINOTRANS-FERASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably not related to study drug.","organSystem":"Investigations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"INCREASE ALPHA-GANNA GLUTAMYL TRANSPEPTIDASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably not related to study drug.","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"ITCHY SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment Ae. 3 possible related and 2 probably related.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"LEUKOCYTOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably related to study drug.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"LOW BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably related to study drug.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"MILD ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably related to study drug.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"MILD DIARRHEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Possible related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"MILD DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Possible related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"MILD HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Probably related to study drug.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"NUMBNESS OF FACE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"NUMBNESS OF FACE AND PALM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"NUMBNESS OF FACE HANDS AND LEGS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"NUMBNESS OF LEGS AND LIPS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment AE. Definitely not related to study drug.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"NUMBNESS OF LIPS"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment SAE. Definitely not related to study drug","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":3,"numAtRisk":12}],"term":"ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment SAE. Definitely not related to study drug","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":12}],"term":"AUTOLOGOUS STEM CELL TRANSPLANT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment SAE. Definitely not related to study drug","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":0,"numAtRisk":12}],"term":"HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment SAE. Definitely not related to study drug","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":0,"numAtRisk":12}],"term":"AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment SAE. Definitely not related to study drug","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":12}],"term":"TREATMENT OF NON-HODGKIN LYMPHOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Post-treatment SAE. Definitely not related to study drug","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":12}],"term":"PEIPHERAL BLOOD STEM CELL HARVEST"}],"timeFrame":"The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)"}