Table 2

Exposure-adjusted incidence of AEs per 100 pt-days, and total number of AEs in Epoch 4 (safety set)

Cumulative dose
<2700 mg (n=44)
Exp.=20 619 pt-days*
Event rate (n)†
Cumulative dose
>2700 mg (n=16)
Exp.=8375 pt-days
Event rate (n)
Total
(n=60)
Exp.=28 994 pt-days
Event rate (n)
Total AEs 1.38 (297)1.92 (161)1.53 (458)
Total AEs excluding FMF and fever 1.21 (262)1.50 (126)1.30 (388)
Infections 0.37 (79)0.33 (28)0.36 (107)
Most common AEs‡
FMF§0.12 (26)0.36 (30)0.19 (56)
Abdominal pain0.03 (6)0.12 (10)0.06 (16)
Headache0.06 (13)0.06 (5)0.06 (18)
Back pain0.03 (7)0.05 (4)0.04 (11)
URTI¶0.04 (9)0.08 (7)0.05 (16)
Fever0.04 (9)0.06 (5)0.05 (14)
Arthralgia0.04 (9)0.06 (5)0.05 (14)
SAEs 0.09 (20)0.04 (3)0.08 (23)
Serious infections 0.02 (5)0.001 (1)0.02 (6)
AEs leading to discontinuation <0.01 (1)0.0 (0)<0.01 (1)
  • *Exp. to canakinumab in each group, in pt-days.

  • †n: total number of events in the 72-week period.

  • ‡AEs (preferred term) occurring in ≥15% of the total population.

  • §Some cases of FMF flares were reported as AEs using this preferred term.

  • ¶URTI, upper respiratory tract infection.

  • AE, adverse event; exp., exposure; FMF, familial Mediterranean fever; pt-days, patient days; SAE, serious AEs.