Table 3.
Adverse events (safety set)
| Variable | Canakinumab 25 mg n=55 | Canakinumab 50 mg n=54 | Canakinumab 100 mg n=54 | Canakinumab 200 mg n=54 | Canakinumab 300 mg n=53 | Canakinumab every 4 weeks n=53 | Canakinumab Any dose n=323 | Colchicine 0.5 mg n=108 |
|---|---|---|---|---|---|---|---|---|
| Any SAE | 2 (3.6) | 2 (3.7) | 3 (5.6) | 3 (5.6) | 3 (5.7) | 1 (1.9) | 14 (4.3) | 6 (5.6) |
| SAE leading to discontinuation | 1 (1.8) | 0 | 1 (1.9) | 2 (3.7) | 0 | 0 | 4 (1.2) | 2 (1.9) |
| Any serious infectious AE | 1 (1.8) | 0 | 0 | 2 (3.7) | 0 | 1 (1.9) | 4 (1.2) | 0 |
| Any AE | 29 (52.7) | 30 (55.6) | 28 (51.9) | 28 (51.9) | 29 (54.7) | 31 (58.5) | 175 (54.2) | 58 (53.7) |
| Any severe AE | 4 (7.3) | 4 (7.4) | 2 (3.7) | 3 (5.6) | 1 (1.9) | 0 | 14 (4.3) | 6 (5.6) |
| Any infectious AE | 11 (20.0) | 8 (14.8) | 10 (18.5) | 11 (20.4) | 8 (15.1) | 10 (18.9) | 58 (18.0) | 13 (12.0) |
| Injection-site reaction | 5 (9.1) | 4 (7.4) | 4 (7.4) | 3 (5.6) | 2 (3.8) | 2 (3.8) | 20 (6.2) | 4 (3.7) |
| AE reported in >5% of patients in any group | ||||||||
| Headache | 4 (7.3) | 3 (5.6) | 1 (1.9) | 2 (3.7) | 6 (11.3) | 3 (5.7) | 19 (5.9) | 6 (5.6) |
| Arthralgia | 4 (7.3) | 5 (9.3) | 4 (7.4) | 2 (3.7) | 3 (5.7) | 2 (3.8) | 20 (6.2) | 3 (2.8) |
| Hypertension | 6 (10.9) | 2 (3.7) | 2 (3.7) | 5 (9.3) | 4 (7.5) | 2 (3.8) | 21 (6.5) | 1 (0.9) |
| Upper respiratory tract infection | 2 (3.6) | 1 (1.9) | 2 (3.7) | 3 (5.6) | 1 (1.9) | 3 (5.7) | 12 (3.7) | 4 (3.7) |
| Back pain | 3 (5.5) | 3 (5.6) | 1 (1.9) | 3 (5.6) | 0 | 0 | 10 (3.1) | 4 (3.7) |
| Nasopharyngitis | 5 (9.1) | 2 (3.7) | 2 (3.7) | 0 | 0 | 3 (5.7) | 12 (3.7) | 1 (0.9) |
| Diarrhoea | 3 (5.5) | 1 (1.9) | 2 (3.7) | 3 (5.6) | 1 (1.9) | 0 | 10 (3.1) | 2 (1.9) |
| Nausea | 2 (3.6) | 1 (1.9) | 3 (5.6) | 0 | 0 | 1 (1.9) | 7 (2.2) | 1 (0.9) |
| Elevated alanine aminotransferase | 3 (5.5) | 1 (1.9) | 0 | 1 (1.9) | 0 | 0 | 5 (1.5) | 1 (0.9) |
| Elevated aspartate aminotransferase | 3 (5.5) | 1 (1.9) | 0 | 1 (1.9) | 0 | 0 | 5 (1.5) | 1 (0.9) |
| Rash | 1 (1.8) | 1 (1.9) | 0 | 0 | 0 | 3 (5.7) | 5 (1.5) | 1 (0.9) |
| Sinus congestion | 0 | 0 | 0 | 0 | 3 (5.7) | 0 | 3 (0.9) | 1 (0.9) |
AE, adverse event; SAE, serious AE.