AEs during the entire study period and AEs experienced by >5% of patients in either group during the entire study period
| LBEC0101 (n=187) | ETN-RP (n=187) | |||
| Patients | Incidence (%) | Patients | Incidence (%) | |
| All AEs | 172 | 92.0 | 173 | 92.5 |
| All related AEs | 96 | 51.3 | 116 | 62.0 |
| Serious AEs | 31 | 16.6 | 20 | 10.7 |
| Deaths | 3 | 1.6 | 1 | 0.5 |
| Serious related AEs | 13 | 7.0 | 13 | 7.0 |
| AEs experienced by >5% of patients in either group (by preferred term) | ||||
| Nasopharyngitis | 46 | 24.6 | 44 | 23.5 |
| Upper respiratory tract infection | 19 | 10.2 | 22 | 11.8 |
| Arthralgia | 14 | 7.5 | 8 | 4.3 |
| Headache | 14 | 7.5 | 6 | 3.2 |
| Back pain | 12 | 6.4 | 10 | 5.3 |
| Hepatic function abnormal | 12 | 6.4 | 6 | 3.2 |
| Constipation | 11 | 5.9 | 4 | 2.1 |
| Abdominal pain upper | 10 | 5.3 | 5 | 2.7 |
| Injection site erythema | 10 | 5.3 | 47 | 25.1 |
| Injection site pruritus | 7 | 3.7 | 38 | 20.3 |
| Latent tuberculosis | 5 | 2.7 | 10 | 5.3 |
| Cough | 5 | 2.7 | 14 | 7.5 |
| Injection site swelling | 4 | 2.1 | 13 | 7.0 |
AEs, adverse events; ETN-RP, etanercept reference product.