Table 2.

Overall incidence of treatment-emergent adverse events occurring in ≥10% of patients receiving sorafenib^a (safety population)

Adverse event	Sorafenib (n=207), n (%)			Placebo (n=209), n (%)
Any grade	Grade 3	Grade 4	Any grade	Grade 3	Grade 4
Hand–foot skin reaction	158 (76.3)	42 (20.3)	–	20 (9.6)	0	–
Diarrhea	142 (68.6)	11 (5.3)	1 (0.5)	32 (15.3)	2 (1.0)	0
Alopecia	139 (67.1)	–	–	16 (7.7)	–	–
Rash/desquamation	104 (50.2)	10 (4.8)	0	24 (11.5)	0	0
Fatigue	103 (49.8)	11 (5.3)	1 (0.5)	53 (25.4)	3 (1.4)	0
Weight loss	97 (46.9)	12 (5.8)	–	29 (13.9)	2 (1.0)	–
Hypertension	84 (40.6)	20 (9.7)	0	26 (12.4)	5 (2.4)	0
Serum TSH increase (MedDRA)b	69 (33.3)	–	–	28 (13.4)	–	–
Anorexia	66 (31.9)	5 (2.4)	0	10 (4.8)	0	0
Oral mucositis (functional/symptomatic)	48 (23.2)	1 (0.5)	1 (0.5)	7 (3.3)	0	0
Pruritus	44 (21.3)	2 (1.0)	–	22 (10.5)	0	–
Nausea	43 (20.8)	0	–	24 (11.5)	0	–
Hypocalcemia	39 (18.8)	12 (5.8)	7 (3.4)	10 (4.8)	1 (0.5)	2 (1.0)
Headache	37 (17.9)	0	–	15 (7.2)	0	–
Cough	32 (15.5)	0	–	32 (15.3)	0	–
Constipation	31 (15.0)	0	0	17 (8.1)	1 (0.5)	0
Shortness of breath	30 (14.5)	10 (4.8)	0	28 (13.4)	4 (1.9)	2 (1.0)
Dry skin	30 (14.5)	1 (0.5)	–	12 (5.7)	0	–
Abdominal pain	29 (14.0)	3 (1.4)	0	8 (3.8)	1 (0.5)	0
Limb pain	28 (13.5)	1 (0.5)	0	18 (8.6)	1 (0.5)	0
ALT	26 (12.6)	5 (2.4)	1 (0.5)	9 (4.3)	0	0
Voice changes	25 (12.1)	1 (0.5)	0	6 (2.9)	0	0
Fever	23 (11.1)	2 (1.0)	1 (0.5)	10 (4.8)	0	0
Vomiting	23 (11.1)	1 (0.5)	0	12 (5.7)	0	0
AST	23 (11.1)	2 (1.0)	0	5 (2.4)	0	0
Back pain	22 (10.6)	2 (1.0)	0	22 (10.5)	2 (1.0)	1 (0.5)
Pain in throat/pharynx/larynx	21 (10.1)	0	0	8 (3.8)	0	0

ALT, alanine transaminase; AST, aspartate transaminase; MedDRA, Medical Dictionary for Regulatory Activities; TSH, thyroid stimulating hormone.

^aNonspecific AEs not included in this table: dermatology – other, metabolic/laboratory – other, and pain – other.

^bStudy-specific AE including TSH concentrations >0.5 mIU/l. Maximum possible severity was grade 1.