Figure 2.
Kaplan-Meier plot of event-free survival in patients with newly diagnosed disease. *The following were considered events during treatment: loss of CHR, loss of MCyR (MCyR includes both PCyR and CCyR), progression to AP/BC (from CP) or to BC (from AP), or death from any cause. †One month after the start of nilotinib treatment, 1 patient temporarily met the technical definition of progression to AP/BC because of increased basophil count. Treatment with nilotinib was temporarily interrupted for 13 days during the first 28-day cycle because of prolonged QT. The patient remained in the study, returned to CP 1 month after progression, and was in CHR after 5.8 months of treatment and in CCyR after 5.3 months of treatment. The patient discontinued from the study because of hyperbilirubinemia after 13.8 months on treatment without losing CHR and CCyR. Progression in this patient was not considered to be clinically notable based on clinical review; however, it was considered as progression to AP/BC in formal statistical analyses. The other patient with an event experienced confirmed loss of MCyR.