TABLE 4.

Patients Experiencing Serious AEs (Non-Liver Transplant)

Serious AE	Placebo Group (n = 12)	Sorafenib Group (n = 16)
Encephalopathy	0	1 (6)*
Neoplasm	1 (8)*	1 (6)†
Diagnostic procedure	0	1 (6)*
Hypoxia	0	1 (6)‡
Mania	1 (8)‡	0
Low platelet count	1 (8)‡	0
Encephalopathy and skin infection (Fournier’s gangrene)	0	1 (6)§

NOTE: Data are given as n (%).

^*CTCAE grade 1.

^†CTCAE grade 2.

^‡CTCAE grade 3.

^§CTCAE grade 5.