Table 3.
TEAEs reported in ≥ 2% of patients by preferred term
| Preferred term | SB4 50 mg (n = 299) | ETN 50 mg (n = 297) |
|---|---|---|
| Upper respiratory tract infection | 24 (8.0) | 16 (5.4) |
| Alanine aminotransferase increased | 18 (6.0) | 17 (5.7) |
| Nasopharyngitis | 15 (5.0) | 16 (5.4) |
| Headache | 13 (4.3) | 8 (2.7) |
| Hypertension | 11 (3.7) | 11 (3.7) |
| Rheumatoid arthritis | 9 (3.0) | 10 (3.4) |
| Aspartate aminotransferase increased | 8 (2.7) | 9 (3.0) |
| Viral infection | 7 (2.3) | 5 (1.7) |
| Injection site erythema | 6 (2.0) | 33 (11.1) |
| Bronchitis | 6 (2.0) | 6 (2.0) |
| Rash | 6 (2.0) | 4 (1.3) |
| Rhinitis | 6 (2.0) | 4 (1.3) |
| Leucopenia | 6 (2.0) | 3 (1.0) |
| Pharyngitis | 5 (1.7) | 8 (2.7) |
| Diarrhoea | 5 (1.7) | 7 (2.4) |
| Urinary tract infection | 5 (1.7) | 7 (2.4) |
| Cough | 4 (1.3) | 10 (3.4) |
| Lymphocyte count decreased | 4 (1.3) | 6 (2.0) |
| 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) | 8 (2.7) |
Values are n (%).