Table 2.

Incidence of drug-related adverse events (all grades) in ≥10% of all patients, n (%)

Part A, 200 mg bid (n = 6)
Part A, 400 mg bid (n = 6)
Part B (n = 19)
All patients (n = 31)
Any gradeGrade ≥3Any gradeGrade ≥3Any gradeGrade ≥3Any gradeGrade ≥3
Cardiovascular
    Hypertension2 (33.3)1 (16.7)1 (16.7)0 (0.0)2 (10.5)0 (0.0)5 (16.1)1 (3.2)
Dermatology/skin
    Other0 (0.0)0 (0.0)1 (16.7)0 (0.0)12 (63.2)2 (10.5)13 (41.9)2 (6.5)
    Rash/desquamation3 (50.0)0 (0.0)2 (33.3)0 (0.0)4 (21.1)0 (0.0)9 (29.0)0 (0.0)
    Dry skin1 (16.7)0 (0.0)0 (0.0)0 (0.0)5 (26.3)0 (0.0)6 (19.4)0 (0.0)
    Alopecia1 (16.7)0 (0.0)3 (50.0)0 (0.0)3 (15.8)0 (0.0)7 (22.6)0 (0.0)
    Pruritus0 (0.0)0 (0.0)2 (33.3)0 (0.0)4 (21.1)1 (5.3)6 (19.4)1 (3.2)
    Hand-foot skin reaction0 (0.0)0 (0.0)2 (33.3)0 (0.0)2 (10.5)1 (5.3)4 (12.9)1 (3.2)
Constitutional symptoms
    Fatigue3 (50.0)0 (0.0)5 (83.3)0 (0.0)4 (21.1)0 (0.0)12 (38.7)0 (0.0)
Gastrointestinal
    Diarrhea6 (100.0)2 (33.3)4 (66.7)0 (0.0)10 (52.6)1 (5.3)20 (64.5)3 (9.7)
    Anorexia1 (16.7)0 (0.0)4 (66.7)0 (0.0)5 (26.3)0 (0.0)10 (32.3)0 (0.0)
    Nausea2 (33.3)0 (0.0)2 (33.3)0 (0.0)7 (36.8)0 (0.0)11 (35.5)0 (0.0)
    Mucositis, oral cavity0 (0.0)0 (0.0)3 (50.0)0 (0.0)1 (5.3)0 (0.0)4 (12.9)0 (0.0)
Metabolic/laboratory
    ALT2 (33.3)1 (16.7)5 (83.3)2 (33.3)6 (31.6)0 (0.0)13 (41.9)3 (9.7)
    AST2 (33.3)1 (16.7)3 (50.0)0 (0.0)4 (21.1)0 (0.0)9 (29.0)1 (3.2)
    Alkaline phosphatase2 (33.3)1 (16.7)1 (16.7)0 (0.0)2 (10.5)0 (0.0)5 (16.1)1 (3.2)
Neurology
    Neuropathy-sensory0 (0.0)0 (0.0)0 (0.0)0 (0.0)6 (31.6)1 (5.3)6 (19.4)1 (3.2)
  • Abbreviation: AST, aspartate aminotransferase.