Table 3.

Study drug interruptions, reductions, and permanent discontinuations due to specific adverse events over the entire course of treatment (safety population)

Adverse event	Sorafenib group (n=207), n (%)			Placebo group (n=209), n (%)
Interruption	Reduction	Discontinuation	Interruption	Reduction	Discontinuation
Hand–foot skin reaction	55 (26.6)	70 (33.8)	11 (5.3)	0	2 (1.0)	0
Rash/desquamation	18 (8.7)	16 (7.7)	3 (1.4)	0	0	0
Hypertension	16 (7.7)	12 (5.8)	1 (0.5)	3 (1.4)	1 (0.5)	0
Diarrhea	7 (3.4)	28 (13.5)	2 (1.0)	2 (1.0)	1 (0.5)	0
Fatigue	15 (7.2)	7 (3.4)	3 (1.4)	3 (1.4)	3 (1.4)	0
Weight loss	5 (2.4)	13 (6.3)	1 (0.5)	2 (1.0)	1 (0.5)	2 (1.0)
Hypocalcemia	4 (1.9)	6 (2.9)	1 (0.5)	0	0	0