Table 3.

Overall Safety and Adverse Events of Interest

Adverse Event	Treatment Group
	Placebo (n = 47)		Linifanib 7.5 mg (n = 42)*		Linifanib 12.5 mg (n = 47)
	No. of Patients	%	No. of Patients	%	No. of Patients	%
Any adverse event	46	97.9	41	97.6	47	100
Any grade 3/4 adverse event	27	57.4	36†	85.7	34	72.3
Any serious adverse event	16	34.0	25†	59.5	25	53.2
Diarrhea
Any grade	10	21.3	13	31.0	21†	44.7
Grade 3/4	1	2.1	1	2.4	4	8.5
Thrombocytopenia
Any grade	7	14.9	13	31.0	19†	40.4
Grade 3/4	1	2.1	7†	16.7	14†	29.8
Anemia
Any grade	9	19.1	17†	40.5	8	17.0
Grade 3/4	4	8.5	5	11.9	2	4.3
Hypertension
Any grade	2	4.3	6	14.3	13†	27.7
Grade 3/4	1	2.1	2	4.8	5	10.6
Dysphonia
Any grade	1	2.1	12†	28.6	7	14.9
Grade 3/4	0	0	0	0	1	2.1
Weight decrease
Any grade	1	2.1	3	7.1	10†	21.3
Grade 3/4	0	0	1	2.4	1	2.1
PPE
Any grade	0	0	3	7.1	8†	17.0
Grade 3/4	0	0	0	0	4	8.5
Hypothyroidism
Any grade	0	0	3	7.1	5	10.6
Grade 3/4	0	0	0	0	0	0
Pneumothorax
Any grade	0	0	4†	9.5	4	8.5
Grade 3/4	0	0	0	0	1	2.1
Oral candidiasis
Any grade	0	0	4†	9.5	3	6.4
Grade 3/4	0	0	0	0	0	0

Abbreviation: PPE, palmar-plantar erythrodysesthesia.

^*Two patients did not receive a dose of linifanib and were not included in the safety analysis.

^†Fisher's exact test P ≤ .05 for comparison with the placebo arm.