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 pain | 0.03 (6) | 0.12 (10) | 0.06 (16) |
| Headache | 0.06 (13) | 0.06 (5) | 0.06 (18) |
| Back pain | 0.03 (7) | 0.05 (4) | 0.04 (11) |
| URTI¶ | 0.04 (9) | 0.08 (7) | 0.05 (16) |
| Fever | 0.04 (9) | 0.06 (5) | 0.05 (14) |
| Arthralgia | 0.04 (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.