{"eventGroups":[{"deathsNumAffected":45,"deathsNumAtRisk":62,"description":"Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.\n\ncyclophosphamide\n\ncyclosporine\n\nmethotrexate\n\nmycophenolate mofetil\n\nsirolimus\n\ntacrolimus\n\nallogeneic hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation\n\ntotal-body irradiation","id":"EG000","otherNumAffected":14,"otherNumAtRisk":62,"seriousNumAffected":4,"seriousNumAtRisk":62,"title":"Regimen I"},{"deathsNumAffected":14,"deathsNumAtRisk":17,"description":"Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.\n\nbusulfan\n\ncyclophosphamide\n\ncyclosporine\n\nmethotrexate\n\nmycophenolate mofetil\n\nsirolimus\n\ntacrolimus\n\nallogeneic hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation","id":"EG001","otherNumAffected":4,"otherNumAtRisk":17,"seriousNumAffected":1,"seriousNumAtRisk":17,"title":"Regimen II"},{"deathsNumAffected":103,"deathsNumAtRisk":130,"description":"Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.\n\ncyclosporine\n\netoposide\n\nmethotrexate\n\nmycophenolate mofetil\n\nsirolimus\n\ntacrolimus\n\nallogeneic hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation\n\ntotal-body irradiation","id":"EG002","otherNumAffected":38,"otherNumAtRisk":130,"seriousNumAffected":7,"seriousNumAtRisk":130,"title":"Regimen III"},{"deathsNumAffected":2,"deathsNumAtRisk":4,"description":"Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.\n\ncyclosporine\n\nfludarabine phosphate\n\nmelphalan\n\nmethotrexate\n\nmycophenolate mofetil\n\nsirolimus\n\ntacrolimus\n\nallogeneic hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation","id":"EG003","otherNumAffected":0,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Regimen IV"},{"deathsNumAffected":32,"deathsNumAtRisk":40,"description":"Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.\n\ncyclosporine\n\nfludarabine phosphate\n\nmethotrexate\n\nmycophenolate mofetil\n\nsirolimus\n\ntacrolimus\n\nallogeneic hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation\n\ntotal-body irradiation","id":"EG004","otherNumAffected":10,"otherNumAtRisk":40,"seriousNumAffected":3,"seriousNumAtRisk":40,"title":"Regimen V"},{"deathsNumAffected":1,"deathsNumAtRisk":2,"description":"Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.\n\nbusulfan\n\ncyclosporine\n\nfludarabine phosphate\n\nmethotrexate\n\nmycophenolate mofetil\n\nsirolimus\n\ntacrolimus\n\nallogeneic hematopoietic stem cell transplantation\n\nperipheral blood stem cell transplantation","id":"EG005","otherNumAffected":1,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Regimen VI"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bone marrow cellularity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Coagulation - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"DIC (disseminated intravascular coagulation)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fibrinogen"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hematuria (in the absence of vaginal bleeding)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemoglobin for leukemia studies or bone marrow infiltrative/myelophthisic processes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage, pulmonary/upper respiratory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage/Bleeding - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"INR (International Normalized Ratio of prothrombin time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Leukocytes (total WBC) for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Melena/GI bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"PTT (Partial Thromboplastin Time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Platelets for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Prothrombin Time"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Transfusion: Platelets for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Transfusion: pRBCs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":130,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Transfusion: pRBCs for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cardiac General - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Conduction abnormality/atrioventricular heart block"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":130,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vasovagal episode"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Auditory/Ear - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hearing: patients without baseline audiogram and not enrolled in a monitoring program"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hot flashes/flushes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dry eye syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ocular surface disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ocular/Visual - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ophthalmoplegia/diplopia (double vision)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vision-blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vision-photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":12,"numAtRisk":130,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diarrhea associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dry mouth/salivary gland (xerostomia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dysphagia-esophageal related to radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Gastrointestinal - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Heartburn/dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Mucositis due to radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Mucositis/stomatitis (functional/symptomatic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":62,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":12,"numAtRisk":130,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":62,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":15,"numAtRisk":130,"numEvents":15},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":40,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Taste alteration (dysgeusia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Constitutional Symptoms - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":15,"numAtRisk":130,"numEvents":15},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":62,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":130,"numEvents":19},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":62,"numEvents":11},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":18},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pain - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Sweating (diaphoresis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":130,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bilirubin associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Liver dysfunction/failure (clinical)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Allergic reaction/hypersensitivity (including drug fever)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":62,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":40,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection with unknown ANC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection without neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":14,"numAtRisk":130,"numEvents":20},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection, Bacterial (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection, Fungal (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection, Viral (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":62,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG002","numAffected":12,"numAtRisk":130,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":130,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"AST, SGOT(serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Acidosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Alkalosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bicarbonate, serum-low"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":130,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Calcium, serum-high (hypercalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":12,"numAtRisk":130,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Calcium, serum-low (hypocalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cholesterol, serum-high (hypercholesteremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":62,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":12,"numAtRisk":130,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":40,"numEvents":5},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Glucose, serum-low (hypoglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Lipase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Magnesium, serum-high (hypermagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":130,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Magnesium, serum-low (hypomagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Metabolic/Laboratory - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Potassium, serum-high (hyperkalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":10,"numAtRisk":130,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":40,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Sodium, serum-high (hypernatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":130,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Uric acid, serum-high (hyperuricemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":19,"numAtRisk":130,"numEvents":26},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Acute graft versus host disease (GVHD) (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Failure to engraft"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":17,"numAtRisk":130,"numEvents":18},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Graft versus host disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Veno-Occlusive Disease (VOD)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Arthritis (non-septic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Musculoskeletal/Soft Tissue - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ataxia (incoordination)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":8,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Extrapyramidal/involuntary movement/restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":130,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Mood alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neurology - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neuropathy: motor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neuropathy: sensory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Somnolence/depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Speech impairment (e.g., dysphasia or aphasia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Syncope (fainting)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bladder spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cystitis (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Renal/Genitourinary - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Urinary frequency/urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Urinary retention (including neurogenic bladder)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Gynecomastia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Sexual/Reproductive Function - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vaginitis (not due to infection)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":130,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Adult Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":130,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":130,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hiccoughs (hiccups, singultus)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":130,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pleural effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":130,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pulmonary/Upper Respiratory - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dermatology/Skin - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hair loss/alopecia (scalp or body)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Injection site reaction/extravasation changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pigmentation changes (e.g., vitiligo)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pruritus/itching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rash/dermatitis associated with high-dose chemotherapy or BMT studies."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":62,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":130,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rash/desquamation associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Urticaria (hives, welts, wheals)"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Coagulation - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage/Bleeding - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage/bleeding associated with surgery, intra-operative or postoperative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Melena/GI bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Platelets for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Portal vein flow"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Thrombotic microangiopathy for BMT studies, if specified by the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cardiac General - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cardiac troponin I (cTnI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pericardial effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diarrhea associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Mucositis/stomatitis (functional/symptomatic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pain - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bilirubin associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Liver dysfunction/failure (clinical)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Infection with unknown ANC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Infection without neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection, Bacterial (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection, Viral (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"AST, SGOT(serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Alkalosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Calcium, serum-low (hypocalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Sodium, serum-high (hypernatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Uric acid, serum-high (hyperuricemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Acute graft versus host disease (GVHD) (COH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Graft versus host disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Veno-Occlusive Disease (VOD)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Extrapyramidal/involuntary movement/restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neuropathy: motor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Somnolence/depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Adult Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":62,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":130,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":130,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pleural effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":130,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pulmonary/Upper Respiratory - Other (Specify, __)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":62,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rash/desquamation associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":62,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":130,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rash: hand-foot skin reaction"}],"timeFrame":"Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 20 years."}