Table 3.

Most common AEs observed in clinical trials of alemtuzumab 12 mg

	CAMMS223 [9, 10] N = 108	CARE-MS I [11] N = 376	CARE-MS II [12] N = 435
AEs occurring in >10% of patients, n (%)
Infusion-associated reactions	106 (98)	338 (90)	393 (90)
Infection	71 (66)	253 (67)	334 (77)
Upper respiratory tract	48 (44)	57 (15)	71 (16)
Urinary tract	10 (9)	64 (17)	93 (21)
Autoimmunity
Any autoimmune thyroid-associated event	28 (26)	68 (18)	69 (16)
Blood and lymphatic system disorders	NR	66 (18)	59 (14)
Lymphopenia	NR	26 (7)	23 (5)
Leukopenia	NR	11 (3)	NR

AEs adverse events, NR not reported