Table 3.

Patient Incidence of Adverse Events

	Arm A AMG 386, 10 mg/kg qw + Sorafenib (n = 50)		Arm B AMG 386, 3 mg/kg qw + Sorafenib (n = 51)		Arm C Placebo + Sorafenib (n = 50)
Patients with any adverse event, %	98		98		100
Grade 3	56		57		74
Grade 4	6		14		10
Grade 5	4		2		2
Adverse events occurring in ≥20% of patients in ≥1 treatment arm, %	All Grades	Grade ≥3	All Grades	Grade ≥3	All Grades	Grade ≥3
Diarrhea	70	8	67	10	56	8
Palmar-plantar erythrodysesthesia syndrome	52	12	47	16	54	28
Alopecia	50	0	45	0	50	2
Hypertension	42	18	49	20	46	14
Decreased appetite	38	2	27	0	20	0
Nausea	30	2	33	2	20	2
Rash	32	0	31	6	30	8
Fatigue	30	2	24	4	22	0
Asthenia	30	2	22	4	20	2
Pruritus	26	0	25	0	24	2
Mucosal inflammation	26	2	20	0	8	2
Cough	26	0	12	0	10	0
Dry skin	24	0	22	0	18	2
Constipation	24	0	12	0	22	2
Insomnia	24	2	12	0	2	0
Vomiting	20	2	22	2	18	2
Pain in extremity	22	2	16	0	16	2
Stomatitis	20	2	12	0	16	2
Upper abdominal pain	20	2	10	2	4	0
Adverse events of specific interest, %
Gastrointestinal perforation	4a	2	0	0	2b	2
Arterial thromboembolic events	8	8c	6	4c	4	4c
Venous thromboembolic events	4	2	4	4	0	0
Cardiac toxicity	2	2d	0	0	0	0
Hemorrhagic events	12	0	14	2	20	2
Impaired wound healing	4	0	6	2	2	0
Proteinuria	16	2	14	0	8	0
Peripheral edema	18	0	16	0	12	0
Hypokalemia	4	2	8	2	4	0
Infusion reactions	6	0	2	0	8	2

^aIncludes 1 grade 1 anal fistula and 1 grade 3 anal abscess.

^bGrade 3 anal fistula and abscess.

^cIncludes 1 grade 4 myocardial infarction.

^dGrade 5 cardiopulmonary failure.