Table 3.

Incidence of all drug-related adverse events

CategoryGrade100 mg bid (n = 3), n (%)200 mg bid (n = 3), n (%)400 mg bid (n = 4), n (%)600 mg bid (n = 6), n (%)800 mg bid (n = 3), n (%)Total (N = 19), n (%)
Any category1 or 2*2 (67)0 (0)2 (50)3 (50)0 (0)7 (37)
30 (0)0 (0)2 (50)0 (0)3 (100)5 (26)
Blood/bone marrow (hemoglobin)1 or 2*0 (0)0 (0)1 (25)1 (16.7)0 (0)2 (11)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Flu-like symptoms (fatigue)1 or 2*0 (0)0 (0)0 (0)0 (0)2 (67)2 (11)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Gastrointestinal
    Anorexia1 or 2*1 (33)0 (0)0 (0)0 (0)1 (33)2 (11)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
    Nausea1 or 2*0 (0)0 (0)1 (25)0 (0)1 (33)2 (11)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
    Stomatitis/pharyngitis1 or 2*0 (0)0 (0)1 (25)0 (0)1 (33)2 (11)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
    Vomiting1 or 2*1 (33)0 (0)1 (25)0 (0)0 (0)2 (11)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Hepatic1 or 2*0 (0)0 (0)2 (50)c d1 (17)e0 (0)3 (16)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Metabolic1 or 2*0 (0)0 (0)2 (50)f1 (17)f0 (0)3 (16)
30 (0)0 (0)1 (25)g0 (0)0 (0)1 (5)
Pulmonary (dyspnea)1 or 2*0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
30 (0)0 (0)0 (0)0 (0)1 (33)1 (5)
Skin
    Pruritis1 or 2*0 (0)0 (0)1 (25)1 (17)2 (67)4 (21)
30 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
    Rash/desquamation1 or 2*0 (0)0 (0)2 (50)1 (17)1 (33)4 (21)
30 (0)0 (0)0 (0)0 (0)2 (67)2 (11)
  • NOTE: No grade 4 drug-related adverse event was experienced by any patient from any group.

  • * Grade 1 or 2 adverse events in >10% of total number of patients.

    cHypoalbumemia, dalkaline phosphatase, ebilirubin, fhypocalcemia, ghyponatremia.