Table 3 Cumulative exposure adjusted event rates for the most frequent adverse events*.

Adverse event	EAE rate on exposure to anakinra† (No of events per 100 patient‐years)
	Placebo‡	0 to 1 y	0 to 2 y	0 to 3 y
	(E = 120.9)	(E = 1041.8)	(E = 1754.8)	(E = 2273.0)
Injection site reactions	135.60	260.12	157.80	122.26
RA progression	122.37	77.46	72.43	67.80
URTI	58.70	33.88	27.81	26.09
Headache	32.25	35.52	23.31	19.05
Arthralgia	19.02	16.41	15.44	13.77
Sinusitis	18.19	15.65	13.16	12.80
Nausea	19.02	20.25	(14.82	12.45
Diarrhoea	16.54	17.09	12.88	11.26

*Adverse events occurring at rates of ⩾10 events per 100 patient‐years.

†Cumulative exposure adjusted event rates in the specified period for 1116 patients randomly assigned to anakinra (873 of whom continued treatment during the open label extension) and 230 patients randomly assigned to placebo who received at least one dose of anakinra the during open label extension.

‡Cumulative exposure adjusted event rates for patients who received placebo during the randomised, double blind phase.

E, number of patient‐years of exposure; EAE, exposure adjusted event; RA, rheumatoid arthritis; URTI, upper respiratory tract infection, y, years.