{"eventGroups":[{"description":"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis\n\nTacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or \"transplant.\" Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":21,"seriousNumAffected":19,"seriousNumAtRisk":21,"title":"Tacrolimus and Thymoglobulin"}],"frequencyThreshold":"0","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":6}],"term":"Alanine Aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21,"numEvents":4}],"term":"Aspartate Aminotransferase (AST)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Asystole"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21,"numEvents":4}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21,"numEvents":4}],"term":"Bilirubin increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":6}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21,"numEvents":8}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":21,"numEvents":5}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Gastric Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"High cholesterol"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21,"numEvents":8}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":21,"numEvents":9}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":21,"numEvents":11}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":21,"numEvents":5}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":21,"numEvents":12}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":6}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21,"numEvents":7}],"term":"Cytomegalovirus (CMV) infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Epstein-Barr virus (EBV) infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"BK virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21,"numEvents":7}],"term":"C diff infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"E coli infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"E faecalis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Enterococcus raffino infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"HSV2 Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"K oxytoca infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Oral candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Staph coagulase neg"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Staph epi infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Staph not aureus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Strep viridans infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"TB infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"UTI infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Citrobacter koseri infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Adenovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Aspirgillus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Bronchial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Gram cocci infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Gram neg coccobacil infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21,"numEvents":8}],"term":"Maculopapular rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21,"numEvents":7}],"term":"Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":21,"numEvents":12}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21,"numEvents":7}],"term":"Sinus Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Troponin increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Wound infection"}]}