Table 6.
Safety during the 12-wk double-blind period n (%)
| Parameter | Immediate treatment, n = 155 | Placebo-deferred treatment, n = 52 |
| AEs leading to discontinuation | 0 (0) | 1 (2)1 |
| Serious AEs | 5 (3)2 | 3 (6)13 |
| AEs (any grade), ≥ 5% | ||
| ALT elevation | 5 (3) | 12 (23) |
| AST elevation | 2 (1) | 8 (15) |
| Hypertension | 11 (7) | 4 (8) |
| Upper respiratory tract infection | 10 (6) | 3 (6) |
| Platelet count decrease | 3 (2) | 4 (8) |
| Pyrexia | 1 (1) | 3 (6) |
| On-treatment grade 3-4 laboratory abnormalities | ||
| ALT | 1 (1) | 5 (10) |
| AST | 1 (1) | 3 (6) |
| Total bilirubin | 1 (1) | 0 (0) |
| Hemoglobin | 3 (2) | 0 (0) |
1
Hepatitis E virus infection and liver injury (n = 1);
2
Treatment related: Study drug overdose (n = 2); Unrelated to treatment: Ventricular extrasystoles (n = 1), acute cholecystitis (n = 1) and intervertebral disc protrusion (n = 1);
3
ALT elevation (n = 1) and coronary artery disease (n = 1). AE: Adverse event; ALT: Alanine transaminase; AST: Aspartate transaminase.