FMF (N = 31) | MKD (N = 26) | TRAPS (N = 7) | |
---|---|---|---|
Total number of AEs reported during canakinumab | 9 | 8 | 1 |
Patients with at least one AE | 7 (22.6) | 6 (23.1) | 1 (14.3) |
Number of AEs reported per patient | |||
0 | 24 (77.4) | 20 (76.9) | 6 (85.7) |
1 | 6 (19.3) | 4 (15.4) | 1 (14.3) |
2 | 0 (0.0) | 2 (7.7) | 0 (0.0) |
3 | 1 (3.2) | 0 (0.0) | 0 (0.0) |
At least one AE suspected to be related to canakinumab exposure | 5 (16.1) | 5 (19.2) | 1 (14.3) |
At least one serious AE* during canakinumab exposure | 4 (12.9) | 1 (3.8) | 1 (14.3) |
At least one serious AE* suspected to be related to canakinumab exposure | 2 (6.4) | 0 (0.0) | 1 (14.3) |
At least one AE leading to canakinumab discontinuation | 2 (6.4) | 1 (3.8) | 1 (14.3) |
Among reported AEs, types of AEs | N = 9 | N = 8 | N = 1 |
Infections | 5 (55.5) | 3 (37.5) | 1 (100.0) |
Skin and subcutaneous tissue disorders | 2 (22.2) | 2 (25.0) | 0 (0.0) |
Gastro-intestinal disorders | 1 (11.1) | 0 (0.0) | 0 (0.0) |
Nutrition disorders | 1 (11.1) | 0 (0.0) | 0 (0.0) |
Renal disorders | 0 (0.0) | 1 (12.5) | 0 (0.0) |
Lipid metabolism disorders | 0 (0.0) | 1 (12.5) | 0 (0.0) |
Nervous system disorders | 0 (0.0) | 1 (12.5) | 0 (0.0) |