Table 3:

Adverse events in the double-blind period in the safety analysis population

	Patients receiving satralizumab (n=63; 115·2 patient-years)		Patients receiving placebo (n=32; 40·6 patient-years)
	Number of patients	Events per 100 patient-years (95% Cl)	Number of patients	Events per 100 patient-years (95% Cl)
Adverse events	58(92%)	473·9 (435 0–515·4)	24(75%)	495·2 (429·1–568·6)
Serious adverse events	12 (19%)	17·4(10·6–26·8)	5 (16%)	14·8 (5·4–32·2)
Severe adverse events	17(27%)	32·1 (22·6–44·3)	2 (6%)	9·9 (2·7–25·2)
Deaths	0	0 (NE–3·2)	0	0 (NE–9·1)
Infections*	34(54%)	99·8 (82·4–119·8)	14(44%)	162·6 (125·8–206·9)
Serious infections*	6 (10%)	5·2 (1·9–11·3)	3(9%)	9·9(2·7–25·2)
Injection-related reactions	8 (13%)	13·9 (7·9–22·6)	5(16%)	17·3 (6·9–35·5)
Anaphylactic reactions†	0	0 (NE–3·2)	0	0 (NE–9·1)

Data are n (%) unless otherwise specified. NE=not evaluable.

^*MedDRA system organ class; infections and infestations.

^†Standardised MedDRA Queries anaphylaxis narrow term.