Table 3.
Treatment-related adverse events reported in at least 1 % of total patients
| CT-P13 (n = 302) | RP (n = 300) | Total CT-P13 + RP (n = 602) | |
|---|---|---|---|
| Infusion-related reaction | 30 (9.9) | 43 (14.3) | 73 (12.1) |
| Latent TB | 22 (7.3) | 20 (6.7) | 42 (7.0) |
| Upper respiratory tract infection | 23 (7.6) | 14 (4.7) | 37 (6.1) |
| Abnormal liver function test | 22 (7.3) | 14 (4.7) | 36 (6.0) |
| Urinary tract infection | 9 (3.0) | 11 (3.7) | 20 (3.3) |
| Lower respiratory tract infection | 10 (3.3) | 9 (3.0) | 19 (3.2) |
| Flare in RA activity | 7 (2.3) | 5 (1.7) | 12 (2.0) |
| Herpes virus infection | 3 (1.0) | 7 (2.3) | 10 (1.7) |
| Anemia | 4 (1.3) | 5 (1.7) | 9 (1.5) |
| Headache | 4 (1.3) | 5 (1.7) | 9 (1.5) |
| Rash | 2 (0.7) | 4 (1.3) | 6 (1.0) |
| Pyrexia | 1 (0.3) | 5 (1.7) | 6 (1.0) |
RA rheumatoid arthritis, RP reference product (i.e. reference infliximab), TB tuberculosis
Data are presented as count (percentage)