Table 2

Most commonly reported adverse events, graded according to the Common Toxicity Criteria of the National Cancer Institute

The occurrence of grade 2 or worse toxicity in three or more patients in a dose level defined an unacceptably toxic dose level. Except as otherwise specified, six patients were entered into each dose level.

200 mg p.o. bid300 mg p.o. bid400 mg p.o. bid
Grade 1Grade 2Grade 1Grade 2Grade 1Grade 2Grade 3
Nausea/Vomiting12121
Indigestion/Heartburn143
Pain/Cramps111121
Decreased appetite111
Change in bowel habits51
Overall GI (any of the above)116a133
Headache4431
Elevated ALT, AST, or bilirubin11a2121
  • a Elevated liver functions felt secondary to cholelithiasis; n = 7 because subject treated for 1 month before withdrawal is included.