Table 3.

Adverse events (≥10% of patients overall) suspected to be related to study treatment

50 mg70 mg140 mg260 mg280 mg350 mg400 mg600 mga600 mgb750 mg900 mg1,200 mgAll
Adverse event, n (%)Graden = 4n = 2n = 4n = 4n = 4n = 5n = 5n = 67n = 7n = 14n = 13n = 3N = 132
Hematologic AEs
 NeutropeniaAll00001 (25)1 (20)2 (40)31 (46)6 (86)8 (57)9 (69)2 (67)60 (46)
3/40000001 (20)19 (28)5 (71)5 (36)5 (39)1 (33)36 (27)
 LeukopeniaAll0001 (25)1 (25)2 (40)1 (20)31 (46)6 (86)6 (43)9 (69)057 (43)
3/4000000013 (19)5 (71)04 (31)022 (17)
 ThrombocytopeniaAll00001 (25)01 (20)23 (34)2 (29)5 (36)6 (46)2 (67)40 (30)
3/400000006 (9)03 (21)01 (33)10 (8)
 AnemiaAll000002 (40)2 (40)19 (28)2 (29)3 (21)3 (23)3 (100)34 (26)
3/400000002 (3)01 (7)01 (33)4 (3)
 LymphopeniaAll0002 (50)1 (25)1 (20)015 (22)3 (43)6 (43)4 (31)032 (24)
3/400001 (25)1 (20)012 (18)2 (29)1 (7)4 (31)021 (16)
Nonhematologic AEs
 FatigueAll2 (50)2 (100)3 (75)4 (100)1 (25)1 (20)1 (20)22 (33)5 (71)5 (36)10 (77)3 (100)59 (45)
3/400000002 (3)1 (14)0003 (2)
 NauseaAll01 (50)002 (50)2 (40)1 (20)30 (45)3 (43)8 (57)6 (46)3 (100)56 (42)
3/400000001 (1)01 (7)002 (2)
 VomitingAll01 (50)0002 (40)2 (40)17 (25)2 (29)4 (29)3 (23)3 (100)34 (26)
3/40000000000000
 DiarrheaAll00001 (25)1 (20)018 (27)04 (29)5 (39)2 (67)31 (23)
3/400000002 (3)00002 (2)
 Electrocardiogram QT prolongedAll00000006 (9)02 (14)4 (31)2 (67)14 (11)
3/400000000002 (15)02 (2)
 Blood creatinine increasedAll000003 (60)1 (20)4 (6)1 (14)3 (21)2 (15)014 (11)
3/40000000000000
 Appetite decreasedAll001 (25)02 (50)1 (20)05 (7)03 (21)1 (8)013 (10)
3/40000000000000
  • Data cutoff: April 24, 2014.

  • a3-weeks-on/1-week-off schedule.

  • bContinuous dosing schedule.