Table 3.

Drug-related adverse events: any grade in ≥10% of patients or grade ≥3 in any patient

Total (n = 43)QD dosingQID dosing
10 mg (n = 3)20 mg (n = 6)25 mg (n = 7)35 mg (n = 3)45 mg (n = 6)55 mg (n = 3)60 mg (n = 3)70 mg (n = 6)80 mg (n = 6)
Any adverse event39 (91)3 (100)6 (100)7 (100)3 (100)5 (83)2 (67)3 (100)6 (100)4 (67)
    Somnolence34 (79)3 (100)6 (100)6 (86)2 (67)3 (50)1 (33)3 (100)6 (100)4 (67)
    Asthenia13 (30)1 (33)2 (33)02 (67)2 (33)1 (33)2 (67)1 (17)2 (33)
    Insomnia7 (16)01 (17)1 (17)1 (33)3 (50)1 (33)000
    Anorexia6 (14)003 (43)02 (33)1 (33)000
    Transaminitis3 (7)01 (17)000001 (17)1 (17)
Any grade ≥ 3 event*7 (16)01 (17)1 (14)01 (17)002 (33)2 (33)
    Somnolence3 (7)001 (14)01 (17)0001 (17)
    Asthenia1 (2)00000001 (17)0
    Transaminitis3 (7)01 (17)000001 (17)1 (17)

NOTE: Values in parentheses are percentages.

Abbreviations: QD, once-daily dosing; QID, 4 times a daily dosing.

  • *No patient had a grade 5 drug-related adverse event.