Treatment-emergent adverse events reported in ≥2% patients by preferred term, n (%)
| Preferred term | SB4 50 mg | ETN 50 mg |
|---|---|---|
| N=299 | N=297 | |
| Upper respiratory tract infection | 21 (7.0) | 15 (5.1) |
| Alanine aminotransferase increased | 15 (5.0) | 14 (4.7) |
| Nasopharyngitis | 14 (4.7) | 15 (5.1) |
| Headache | 13 (4.3) | 8 (2.7) |
| Hypertension | 10 (3.3) | 10 (3.4) |
| Aspartate aminotransferase increased | 7 (2.3) | 8 (2.7) |
| Viral infection | 7 (2.3) | 5 (1.7) |
| Injection site erythema | 6 (2.0) | 33 (11.1) |
| Rheumatoid arthritis | 6 (2.0) | 9 (3.0) |
| Bronchitis | 6 (2.0) | 6 (2.0) |
| Diarrhoea | 5 (1.7) | 7 (2.4) |
| Pharyngitis | 4 (1.3) | 8 (2.7) |
| Urinary tract infection | 4 (1.3) | 7 (2.4) |
| Lymphocyte count decreased | 4 (1.3) | 6 (2.0) |
| Cough | 3 (1.0) | 10 (3.4) |
| Erythema | 2 (0.7) | 10 (3.4) |
| Dizziness | 2 (0.7) | 7 (2.4) |
| Injection site rash | 2 (0.7) | 6 (2.0) |
| Injection site reaction | 1 (0.3) | 7 (2.4) |