{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"description":"The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events:\n\n* Musculoskeletal and connective tissue disorders: grade 2-5\n* Hepatobiliary disorders: grade 2-5\n* Other unexpected events thought related to the use of atorvastatin; grade 2-5\n\nIn cases where the NCI criteria do not apply, intensity will be defined as:\n\n* Mild: awareness of symptom or sign, but easily tolerated\n* Moderate: discomfort is enough to cause interference with normal activities\n* Severe: inability to perform normal daily activities\n* Life threatening: immediate risk of death from the reaction as it occurred","groups":[{"description":"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.\n\nTRANSPLANT: Patients undergo donor PBSC transplant on day 0.\n\nPOST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.","id":"OG000","title":"Primary - Reg A (Flu/TBI)"},{"description":"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.\n\nTRANSPLANT: Patients undergo donor PBSC transplant on day 0.\n\nPOST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.","id":"OG001","title":"Primary - Reg B (TBI Alone)"},{"description":"NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.\n\nPOST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.","id":"OG002","title":"Adjunct"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Prior to stem cell collection","title":"Number of Donors Discontinuing Atorvastatin Due to Toxicity","type":"SECONDARY","unitOfMeasure":"Participants"}