Table 3.

Adverse Events

	Hepatic Function Group [N (%), E] (Safety Analysis Set)
System Organ Class and Preferred Term	Normal (n = 24)	Mild (n = 12)	Moderate (n = 12)	Severe (n = 8)	Total (N = 56)
Overall AEs	16 (66.7), 31	5 (41.7), 18	1 (8.3), 1	5 (62.5), 8	27 (48.2), 58
AEs occurring in >3% of subjects overall:
Headache	7 (29.2), 8	1 (8.3), 1	0	0	8 (14.3), 9
Dyspepsia	2 (8.3), 2	2 (16.7), 4	0	1 (12.5), 1	5 (8.9), 7
Vomiting	3 (12.5), 4	1 (8.3), 2	0	0	4 (7.1), 6
Decreased appetite	2 (8.3), 2	2 (16.7), 2	0	0	4 (7.1), 4
Diarrhea	1 (4.2), 1	1 (8.3), 2	0	1 (12.5), 1	3 (5.4), 4
Abdominal pain	1 (4.2), 3	0	0	1 (12.5), 1	2 (3.6), 4

AE, adverse event; E, number of AEs; N/n, number of subjects with AE; %, proportion of subjects with AE.