{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"description":"Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.","groups":[{"description":"Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Single Arm Nilotinib Relapse Prophylaxis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Critical to note are two \"intention-to-treat\" populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib.","reportingStatus":"POSTED","timeFrame":"Up to 365 days post-transplant","title":"Number of Participants With Treatment Safety Failure","type":"PRIMARY","unitOfMeasure":"Participants"}