Table 3.

Summary of adverse events during 12-week blinded-dosing phase

	Entecavir 1 mg (n = 116)	Placebo (n = 29)
Any adverse event (%)a	38 (33)	8 (28)
Most frequent adverse events (%)
Fatigue	8 (7)	2 (7)
Upper respiratory tract infection	8 (7)	0
ALT increased	2 (2)	3 (10)
AST increased	2 (2)	3 (10)
Abdominal discomfort	2 (2)	2 (7)
Dizziness	1 (<1)	4 (14)
Serious adverse event (%)	0 (0)	1 (3)
Discontinuation due to adverse event (%)	0 (0)	1 (3)
Death	0 (0)	0

ALT, alanine aminotransferase; AST, aspartate aminotransferase

^aIncluding laboratory abnormalities reported by investigator as an adverse event