Table 2

Nilotinib exposure and dose intensity (400 mg twice daily)

CML-CP (n = 95)CML-AP (n = 27)
Median duration of nilotinib therapy, mo (range) 24.7 (0-36) 5.1 (0-38) 
Median dose intensity,* mg/d (range) 724 (151-800) 769 (184-1149) 
Patients with dose interruptions attributable to any AE, n (%) 65 (68) 13 (48) 
Median duration of cumulative dose interruptions, d (range) 24 (1-345) 17 (4-234) 
Median percentage time lost to dose interruptions while on nilotinib therapy, % (range) 2.4 (0-60.1) 1.1 (0-47.2) 
CML-CP (n = 95)CML-AP (n = 27)
Median duration of nilotinib therapy, mo (range) 24.7 (0-36) 5.1 (0-38) 
Median dose intensity,* mg/d (range) 724 (151-800) 769 (184-1149) 
Patients with dose interruptions attributable to any AE, n (%) 65 (68) 13 (48) 
Median duration of cumulative dose interruptions, d (range) 24 (1-345) 17 (4-234) 
Median percentage time lost to dose interruptions while on nilotinib therapy, % (range) 2.4 (0-60.1) 1.1 (0-47.2) 

AE indicates adverse event; AP, accelerated phase; CML, chronic myeloid leukemia; and CP, chronic phase.

*

Actual average dose intensity = cumulative dose given (ie, daily dose in mg/day)/duration of exposure (day).

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