Table 3 Summary of safety analyses for all randomised patients up to week 20.

Preferred term	Daclizumab 2 mg/kg (n = 47)	Daclizumab 1 mg/kg (n = 56)	Placebo (n = 56)
Nasopharyngitis	6 (12.8%)	9 (16.1%)	5 (8.9%)
Pyrexia	6 (12.8%)	5 (8.9%)	0
Abdominal pain	6 (12.8%)	3 (5.4%)	5 (8.9%)
Sinusitis	6 (12.8%)	1 (1.8%)	2 (3.6%)
Headache	5 (10.6%)	10 (17.9%)	10 (17.9%)
Nausea	5 (10.6%)	7 (12.5%)	6 (10.7%)
Influenza	5 (10.6%)	2 (3.6%)	5 (8.9%)
Colitis ulcerative	4 (8.5%)	9 (16.1%)	3 (5.4%)
Pruitus	1 (2.1%)	7 (12.5%)	1 (1.8%)

Adverse events reported in ⩾10% daclizumab treated subjects. Intention to treat subjects (n = 159).