Table 3.

Safety of the Intention-to-Treat Population

Events	ETV + BR (n = 500)	ETV + Placebo (n = 500)	P Value
Adverse events	385 (77.0)	366 (73.2)	.32
Serious adverse events	44 (8.8)	43 (8.6)	.88
Discontinuation due to adverse events	1 (0.2)	1 (0.2)	1.00
ALT > 2 times baseline and > 10 times ULN	17 (3.4)	19 (3.8)	.52
Death	1 (0.2)	3 (0.6)	.23

Data are presented as No. (%) unless otherwise indicated.

Abbreviations: ALT, alanine aminotransferase; BR, Biejia-Ruangan; ETV, entecavir; ULN, upper limit of normal.