Table 3.

Treatment-emergent adverse events by preferred term occurring in at least two patients from all pateclizumab-treated groups combined during either single or multiple ascending dose phases^a

	SAD cohorts, n (%)		MAD cohorts, n (%)
Adverse events	Placebo (n = 6)	All active (n = 24)	Placebo (n = 7)	1.0 mg/kg SC (n = 8)	3.0 mg/kg SC (n = 16)	5.0 mg/kg IV (n = 4)	All active (n = 28)
Any event	3 (50.0)	20 (66.7)	4 (57.1)	7 (87.5)	8 (50.0)	1 (25.0)	20 (57.1)
Fatigue	0 (0.0)	2 (8.3)	1 (14.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Rheumatoid arthritis	0 (0.0)	2 (8.3)	0 (0.0)	1 (12.5)	1 (6.3)	0 (0.0)	2 (7.1)
Rash	0 (0.0)	2 (8.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Diarrhea	0 (0.0)	1 (4.2)	0 (0.0)	3 (37.5)	1 (6.3)	0 (0.0)	4 (14.3)
Vomiting	0 (0.0)	0 (0.0)	0 (0.0)	2 (25.0)	0 (0.0)	0 (0.0)	2 (7.1)
Nasopharyngitis	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (12.5)	0 (0.0)	2 (7.1)
Headache	0 (0.0)	1 (4.2)	0 (0.0)	2 (25.0)	1 (6.3)	1 (25.0)	4 (14.3)
Rhinorrhea	0 (0.0)	0 (0.0)	0 (0.0)	1 (12.5)	1 (6.3)	0 (0.0)	2 (7.1)

^aIV = intravenously; MAD = multiple ascending dose; SAD = single ascending dose; SC = subcutaneously.