Table 2.

Incidence of AEs in parts 1 and 2 of the study following adjustment for canakinumab exposure^*

	Part 1			Part 2
	Cohort 1 (n = 68)	Cohort 2(n = 98)	Total (n = 166)	Dose reduction arm (n = 38)	Dose interval prolongation arm (n = 37)
Total AEs	1.64 (521)	2.45 (1,043)	2.11 (1,564)	1.59 (361)	1.32 (291)
Common AEs†
Pyrexia	0.04 (13)	0.15 (63)	0.10 (76)	0.07 (17)	0.06 (13)
Nasopharyngitis	0.10 (32)	0.09 (38)	0.09 (70)	0.07 (16)	0.08 (18)
Headache	0.07 (21)	0.09 (37)	0.08 (58)	0.04 (10)	0.07 (16)
Arthralgia	0.04 (14)	0.08 (36)	0.07 (50)	0.07 (15)	0.05 (11)
Diarrhea	0.01 (3)	0.09 (39)	0.06 (42)	0.03 (7)	0.01 (2)
Cough	0.03 (10)	0.07 (29)	0.05 (39)	0.05 (11)	0.01 (3)
Rash	0.02 (5)	0.06 (25)	0.04 (30)	0.02 (4)	0.03 (7)
Upper respiratory tract infection	0.07 (22)	0.04 (18)	0.05 (40)	0.07 (16)	0.03 (6)
Viral infection	0.01 (4)	0.02 (8)	0.02 (12)	0.05 (12)	0.01 (3)
Serious AEs	0.05 (15)	0.08 (34)	0.07 (49	0.02 (4)	0.01 (2)
Study drug discontinuation due to AEs, no.	3	12	15	1	0

^*Except where indicated otherwise, values are the number of adverse events (AEs) per 100 patient‐days in the safety set (total number of AEs).

^†Common AEs were defined as those with incidence rates of >0.05 per 100 patient‐days in either cohort or treatment arm.