Table 3.

SAEs reported in at least three participants in the total safety population.^a

SAE, n (%)	IFN/DAC,a n = 597	Continuous DAC beta, n = 606	Total safety population, N = 1203
Multiple sclerosis relapse	61 (10)	65 (11)	126 (10)
Lymphadenopathy	4 (<1)	10 (2)	14 (1)
Pneumonia	5 (<1)	8 (1)	13 (1)
Urinary tract infection	6 (1)	3 (<1)	9 (<1)
Fall	1 (<1)	7 (1)	8 (<1)
Cholelithiasis	5 (<1)	2 (<1)	7 (<1)
Multiple sclerosis	3 (<1)	3 (<1)	6 (<1)
Pyrexia	3 (<1)	3 (<1)	6 (<1)
Drug-induced liver injury	4 (<1)	1 (<1)	5 (<1)
Epilepsy	2 (<1)	3 (<1)	5 (<1)
Lymphadenitis	2 (<1)	3 (<1)	5 (<1)
Lymphoid tissue hyperplasia	4 (<1)	1 (<1)	5 (<1)
Psoriasis	3 (<1)	2 (<1)	5 (<1)
Suicide attempt	2 (<1)	3 (<1)	5 (<1)
Breast cancer	3 (<1)	1 (<1)	4 (<1)
Cholecystitis	2 (<1)	2 (<1)	4 (<1)
Hemolytic anemia	2 (<1)	2 (<1)	4 (<1)
Inguinal hernia	2 (<1)	2 (<1)	4 (<1)
Uterine leiomyoma	0	4 (<1)	4 (<1)
Agranulocytosis	1 (<1)	2 (<1)	3 (<1)
ALT increased	1 (<1)	2 (<1)	3 (<1)
Appendicitis	1 (<1)	2 (<1)	3 (<1)
AST increased	1 (<1)	2 (<1)	3 (<1)
Dermatitis contact	3 (<1)	0	3 (<1)
Eczema	2 (<1)	1 (<1)	3 (<1)
Encephalitis autoimmune	3 (<1)	0	3 (<1)
Hepatitis toxic	1 (<1)	2 (<1)	3 (<1)
Pancreatitis	2 (<1)	1 (<1)	3 (<1)
Pancreatitis acute	3 (<1)	0	3 (<1)
Pulmonary sarcoidosis	0	3 (<1)	3 (<1)
Rash generalized	0	3 (<1)	3 (<1)
Rash maculopapular	2 (<1)	1 (<1)	3 (<1)
Respiratory tract infection	1 (<1)	2 (<1)	3 (<1)
Septic shock	2 (<1)	1 (<1)	3 (<1)
Syncope	1 (<1)	2 (<1)	3 (<1)
Thrombocytopenia	3 (<1)	0	3 (<1)

^aBased on the MedDRA preferred term (version 16.1).

ALT, alanine aminotransferase; AST, asparatate aminotransferase; DAC, daclizumab; IFN, interferon; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.