{"eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":15,"description":"Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment.\n\nmycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration.\n\nSargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.\n\nPatients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis.\n\nNote: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.","id":"EG000","otherNumAffected":15,"otherNumAtRisk":15,"seriousNumAffected":15,"seriousNumAtRisk":15,"title":"Arm I (MMF-15, Sargramostim)"},{"deathsNumAffected":6,"deathsNumAtRisk":11,"description":"Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment.\n\nmycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration.\n\nFilgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.","id":"EG001","otherNumAffected":10,"otherNumAtRisk":11,"seriousNumAffected":11,"seriousNumAtRisk":11,"title":"Arm II (MMF-30, Filgrastim)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":15,"numEvents":12},{"groupId":"EG001","numAffected":4,"numAtRisk":11,"numEvents":7}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":15,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":15,"numEvents":12},{"groupId":"EG001","numAffected":5,"numAtRisk":11,"numEvents":8}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":15,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":11,"numEvents":6}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"CD4 Lymphocytes Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"White Blood Cell Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Atrial Fibrilation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Catheter Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Ventricular Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":15,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":11,"numEvents":8}],"term":"Lymphocyte Count Decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":15,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Catheter Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"cardiac disorders, other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"surgical and medical procedures, other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Alanine Aminotransferase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Anal Fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Colonic Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Entercolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Gastrointestinal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hepatic Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Ileal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Memory Impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Mucositis Oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Small Intestine Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Upper Respiratory Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Wound Infection"}],"timeFrame":"All Cause Mortality assessed for 2 years. Serious Adverse Events (SAE's) and Adverse Events (AE's) (Other, not included serious) assessed for 6 months."}