Table 5 Adverse events with frequency of 5% or more in any treatment group.
| Preferred term | Placebo (%) (n = 43) | Fontolizumab | Total (%) (n = 133) | |
|---|---|---|---|---|
| 4 mg/kg (%) (n = 45) | 10 mg/kg (%) (n = 45) | |||
| Abdominal pain | 1 (2.3) | 3 (6.7) | 6 (13.3) | 10 (7.5) |
| Crohn's disease | 4 (9.3) | 4 (8.9) | 2 (4.4) | 10 (7.5) |
| CRP increased | 4 (9.3) | 1 (2.2) | 2 (4.4) | 7 (5.3) |
| Vomiting | 0 | 4 (8.9) | 2 (4.4) | 6 (4.5) |
| Headache | 1 (2.3) | 2 (4.4) | 3 (6.7) | 6 (4.5) |
| Nausea | 2 (4.7) | 1 (2.2) | 3 (6.7) | 6 (4.5) |
| Arthralgia | 0 | 0 | 4 (8.9) | 4 (3.0) |
| Asthenia | 1 (2.3) | 0 | 3 (6.7) | 4 (3.0) |
| Cough | 0 | 0 | 3 (6.7) | 3 (2.3) |
CRP, C reactive protein.