Summary of adverse events (safety population)
| ABP 501 (n=67) | Adalimumab (USA) (n=69) | Adalimumab (EU) (n=67) | |
|---|---|---|---|
| Any treatment-emergent AE, n (%) | 39 (58.2) | 33 (47.8) | 46 (68.7) |
| Any serious AE, n (%) | 0 | 0 | 1 (1.5) |
| Treatment-emergent AEs reported in >5% of subjects in any treatment group, n (%)* | |||
| Headache | 19 (28.4) | 16 (23.2) | 13 (19.4) |
| Oropharyngeal pain | 6 (9.0) | 6 (8.7) | 3 (4.5) |
| Sinus congestion | 6 (9.0) | 6 (8.7) | 0 |
| Nasopharyngitis | 4 (6.0) | 0 | 7 (10.4) |
| Nausea | 5 (7.5) | 2 (2.9) | 4 (6.0) |
| Diarrhoea | 1 (1.5) | 1 (1.4) | 8 (11.9) |
| Vomiting | 1 (1.5) | 2 (2.9) | 5 (7.5) |
| Back pain | 1 (1.5) | 1 (1.4) | 5 (7.5) |
| Dizziness | 1 (1.5) | 1 (1.4) | 4 (6.0) |
| Dysmenorrhoea | 1 (1.5) | 4 (5.8) | 1 (1.5) |
| Nasal congestion | 1 (1.5) | 4 (5.8) | 0 |
*By preferred term.
AE, adverse event.