Table 2. Safety and tolerability: treatment-related adverse events observed in ≥20% subjects and hepatotoxicity adverse events.

Adverse Event, n (%)		400 mg (n = 6)		600 mg (n = 6)			800 mg (n = 3)		Overall (n = 15)
ALT increased		4 (66.7)		5 (83.3)			3 (100.0)		12 (80.0)
AST increased		4 (66.7)		5 (83.3)			3 (100.0)		12 (80.0)
Diarrhea		3 (50.0)		3 (50.0)			2 (66.7)		8 (53.3)
Nausea		1 (16.7)		4 (66.7)			2 (66.7)		7 (46.7)
Blood creatinine increased		2 (33.3)		2 (33.3)			1 (33.3)		5 (33.3)
Constipation		3 (50.0)		1 (16.7)			1 (33.3)		5 (33.3)
Decreased appetite		1 (16.7)		1 (16.7)			1 (33.3)		3 (20.0)
Dysgeusia		1 (16.7)		1 (16.7)			1 (33.3)		3 (20.0)
Malaise		0		2 (33.3)			1 (33.3)		3 (20.0)
Vomiting		2 (33.3)		0			1 (33.3)		3 (20.0)
Adverse Event, n (%)	Grade 1/2		Grade 3		Grade 4	All subjects
ALT increased	9 (75.0)		3 (25.0)		0	12
AST increased	11 (91.7)		1 (8.3)		0	12

Abbreviations: ALT, alanine aminotransferase, AST, aspartate aminotransferase.

The two most frequent adverse events are also represented by grade.