Study flow and outcomes through 3 years of follow-up on all patients.1One of 17 patients ineligible to begin study therapy at engraftment had QTc >450 and absolute neutrophil count <1500. 2Median 300 mg twice daily (range 300 mg once daily to 300 mg twice daily), 6 to 7 days per week. 3Median 400 mg once daily, 6 to 7 days per week. 4Two subjects with I-SL per protocol switched to full-dose nilotinib at day 81; 1 later developed T315I and F311L mutations in the marrow at day 236, progressed, and died at day 638. The other developed the Y253H mutation at day 198, was switched to dasatinib, and survived. 5Intended dose ≥400 mg once daily (range 400 mg daily to 400 mg twice daily), from day 81 until day 445, 6 to 7 days per week. 6Five of these 11 patients tolerated 400 mg twice daily. 7Six of these 13 patients tolerated 400 mg twice daily. Pale green shaded boxes indicate 9 discontinuations due to QTc prolongation from the 57 subjects in the initial ITT population. ARDS, acute respiratory distress syndrome; BM, bone marrow; CNS, central nervous system; Conj. Bili, conjugated bilirubin; GVHD, graft-versus-host disease; NRM, nonrelapse mortality; Plts, platelets.
