Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study

Table 2 Summary of AEs in SELECTED by time intervals and overall

AE, n (%)	Daclizumab 150 mg SC
	Weeks 1–48^a	Weeks 49–96^b	Week 97 and above^c	Overall
	(n = 410)	(n = 387)	(n = 279)	(N = 410)
All AEs	245 (60)	222 (57)	126 (45)	312 (76)
AEs by severity^d
Mild	122 (30)	96 (25)	45 (16)	101 (25)
Moderate	110 (27)	115 (30)	70 (25)	178 (43)
Severe	13 (3)	11 (3)	11 (4)	33 (8)
All SAEs	53 (13)	47 (12)	34 (12)	105 (26)
SAEs (excluding MS relapse)	23 (6)	26 (7)	20 (7)	66 (16)
AEs leading to treatment discontinuation	22 (5)	17 (4)	9 (3)	48 (12)
Death	0	0	0	0

AE Adverse event, MS Multiple sclerosis, SAE Serious adverse event, SC Subcutaneous
^aWeeks 1–48 of SELECTED represents the second year of daclizumab treatment in patients who were newly treated with daclizumab in SELECTION [4] and the third year of treatment in patients originally treated with daclizumab in SELECT [3]
^bWeeks 49–96 represents the third year of daclizumab treatment in patients who were newly treated with daclizumab in SELECTION [4] and the fourth year of treatment in patients originally treated with daclizumab in SELECT [3]
^cWeek 97 and above represents the fourth year and above of daclizumab treatment in patients who were newly treated with daclizumab in SELECTION [4] and the fifth year and above of treatment in patients originally treated with daclizumab in SELECT [3]
^dPatients counted in the category of maximum severity experienced in the time interval

ISSN: 1471-2377