Table 3.

Drug-Related Adverse Events Observed in More Than One Patient

Adverse Event*	Prandial State
	Fasted Overnight (n = 27)	Low-Fat Breakfast (n = 26)	High-Fat Breakfast (n = 27)
Diarrhea with all doses
Grades 1 and 2
No.	6 and 1	5 and 1	9 and 0
%	22 and 4	19 and 4	33 and 0
Onset, days
Median	0	0	0.5
Range	0–2	0–1	0–2
Duration, days
Median	2	3.5	2
Range	1–44	1–29	1–65
Diarrhea with first dose only
Grades 1 and 2
No.	3 and 0	2 and 0	3 and 0
%	11 and 0	8 and 0	11 and 0
Onset, days
Median	0	0.5	1
Range	0–1	0–1	0–1
Duration, days
Median	2	2.5	2
Range	2–44	1–4	1–65
Nausea
Grade 1
No.	5	1	2
%	19	4	7
Fatigue
Grade 1
No.	3	1	1
%	11	4	4
Rash
Grades 1 and 3
No.	1 and 0	1 and 0	0 and 1
%	4 and 0	4 and 0	0 and 4

^*Adverse events are categorized by severity, onset, and duration. Onset measured relative to preceding dose; duration measured relative to onset. Adverse events severity measured by National Cancer Institute Common Toxicity Criteria.