Canakinumab pooled dose | Placebo | ||||
---|---|---|---|---|---|
Low dose | Intermediate dose | Medium dose | High dose | ||
N = 20 | N = 247 | N = 268 | N = 137 | N = 354 | |
Infections and infestations | |||||
n (%) | 0 | 1 (0.4) | 1 (0.4) | 3 (2.2) | 2 (0.6) |
IR (%) | 0.06 | 0.11 | 0.34 | 0.12 | |
Renal and urinary disorders | |||||
n (%) | 0 | 1 (0.4) | 2 (0.7) | 1 (0.7) | 1 (0.3) |
IR (%) | 0.06 | 0.22 | 0.11 | 0.06 | |
Gastrointestinal disorders | |||||
n (%) | 0 | 0 | 1 (0.4) | 1 (0.7) | 1 (0.3) |
IR (%) | 0.11 | 0.11 | 0.06 | ||
Cardiac disorders | |||||
n (%) | 0 | 0 | 0 | 1 (0.7) | 5 (1.4) |
IR (%) | 0.11 | 0.29 | |||
Hepatobiliary disorders | |||||
n (%) | 0 | 0 | 1 (0.4) | 0 | 1 (0.3) |
IR (%) | 0.11 | 0.06 | |||
General disorders and administration site conditions | |||||
n (%) | 0 | 0 | 0 | 0 | 1 (0.3) |
IR (%) | 0.06 | ||||
Musculoskeletal and connective tissue disorders | |||||
n (%) | 0 | 1 (0.4) | 0 | 0 | 1 (0.3) |
IR (%) | 0.06 | 0.06 | |||
Metabolism and nutrition disorders | |||||
n (%) | 0 | 0 | 0 | 2 (1.5) | 0 |
IR (%) | 0.23 | ||||
Investigations | |||||
n (%) | 0 | 0 | 0 | 1 (0.7) | 0 |
IR (%) | 0.11 | ||||
Neoplasms—benign, malignant and unspecified (including cysts and polyps) | |||||
n (%) | 0 | 0 | 0 | 1 (0.7) | 0 |
IR (%) | 0.11 | ||||
Injury, poisoning and procedural complications | |||||
n (%) | 0 | 0 | 1 (0.4) | 0 | 0 |
IR (%) | 0.11 | ||||
Nervous system disorders | |||||
n (%) | 0 | 1 (0.4) | 0 | 0 | 0 |
IR (%) | 0.06 | ||||
Reproductive system and breast disorders | |||||
n (%) | 0 | 1 (0.4) | 0 | 0 | 0 |
IR (%) | 0.06 |