Table 2.

Patient incidence of AEs

Patients with AEs, n (%)Arm 1 (AMG 232)Arm 2 (AMG 232 +T)All patients (N = 36)
60 mg (n = 4)90 mg (n = 4)180 mg (n = 5)240 mg (n = 3)360 mg (n = 10)60 mg (n = 10)
Any AE4 (100)3 (75)5 (100)3 (100)10 (100)10 (100)35 (97)
Any serious AE3 (75)2 (50)4 (80)2 (67)4 (40)3 (30)17 (47)
Treatment-related AEs3 (75)2 (50)5 (100)3 (100)9 (90)9 (90)31 (86)
 Grade 31 (25)2 (50)2 (40)2 (67)4 (40)5 (50)16 (44)
 Grade 41 (25)1 (25)3 (60)1 (33)1 (10)3 (30)10 (28)
Common treatment-related AEs*
 Nausea3 (75)1 (25)3 (60)1 (33)5 (50)8 (80)21 (58)
  Worst grade 30 (0)0 (0)0 (0)0 (0)0 (0)1 (10)1 (3)
 Diarrhea1 (25)1 (25)4 (80)2 (67)7 (70)5 (50)20 (56)
  Worst grade 30 (0)0 (0)0 (0)0 (0)1 (10)1 (10)2 (6)
 Vomiting0 (0)1 (25)2 (40)1 (33)2 (20)6 (60)12 (33)
  Worst grade 30 (0)0 (0)0 (0)0 (0)2 (20)0 (0)2 (6)
 Decreased appetite0 (0)0 (0)2 (40)0 (0)3 (30)4 (40)9 (25)
 Anemia0 (0)2 (50)1 (20)1 (33)1 (10)3 (30)8 (22)
  Worst grade 30 (0)2 (50)1 (20)1 (33)0 (0)3 (30)7 (19)
 Leukopenia0 (0)1 (25)2 (40)0 (0)1 (10)2 (20)6 (17)
  Worst grade 40 (0)1 (25)2 (40)0 (0)1 (10)2 (20)6 (17)
 Thrombocytopenia1 (25)1 (25)1 (20)1 (33)1 (10)1 (10)6 (17)
  Worst grade 31 (25)0 (0)0 (0)0 (0)0 (0)0 (0)1 (3)
  Worst grade 40 (0)1 (25)1 (20)1 (33)1 (10)1 (10)5 (14)
 Fatigue0 (0)0 (0)2 (40)0 (0)1 (10)2 (20)5 (14)
  Worst grade 30 (0)0 (0)0 (0)0 (0)0 (0)1 (10)1 (3)
 Abdominal pain1 (25)0 (0)0 (0)1 (33)0 (0)2 (20)4 (11)
  • T, trametinib.

  • * Treatment-related AEs occurring in ≥10% of all patients are shown.