Table 4.

Serious adverse events by treatment group (safety population)

Serious adverse event, n (%) of subjects		MEDI-528
	Placebo	30 mg	100 mg	300 mg	Combined
	(n = 82)	(n = 81)	(n = 83)	(n = 81)	(n = 245)
Asthma	0 (0.0)	6 (7.4)	1 (1.2)	2 (2.5)	9 (3.7)
Pneumonia	0 (0.0)	3 (3.7)	0 (0.0)	0 (0.0)	3 (1.2)
Food allergy	0 (0.0)	1 (1.2)	0 (0.0)	0 (0.0)	1 (0.4)
Bronchitis	0 (0.0)	1 (1.2)	0 (0.0)	0 (0.0)	1 (0.4)
Lobar pneumonia	0 (0.0)	0 (0.0)	1 (1.2)	0 (0.0)	1 (0.4)
Limb traumatic amputation	0 (0.0)	1 (1.2)	0 (0.0)	0 (0.0)	1 (0.4)
Thoracic vertebral fracture	0 (0.0)	0 (0.0)	1 (1.2)	0 (0.0)	1 (0.4)
Muscle spasms	0 (0.0)	0 (0.0)	1 (1.2)	0 (0.0)	1 (0.4)
Uterine leiomyoma	0 (0.0)	0 (0.0)	1 (1.2)	0 (0.0)	1 (0.4)
Complicated migraine	0 (0.0)	1 (1.2)	0 (0.0)	0 (0.0)	1 (0.4)
Ischemic stroke	0 (0.0)	1 (1.2)	0 (0.0)	0 (0.0)	1 (0.4)
Vaginal hemorrhage	0 (0.0)	0 (0.0)	1 (1.2)	0 (0.0)	1 (0.4)
Pancreatitis	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Cholelithiasis	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Hydrocholecystis	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Appendicitis	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Nephrolithiasis	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)