Event, N (%) | FIB-4 ≤ 3.25 (N = 635) | FIB-4 > 3.25 (N = 188) | p value |
---|---|---|---|
Adverse events, > 3% | 77 (12.1) | 28 (15) | 0.38 |
Abdominal discomfort | 28 (4.4) | 11 (5.9) | 0.53 |
 Fatigue | 26 (4.1) | 11 (5.9) | 0.41 |
 Skin itching | 23 (3.6) | 6 (3.2) | 0.96 |
Laboratory adverse event | 14 (2.2) | 32 (17) |  < 0.001 |
 Total bilirubin elevation | 6 (0.9) | 21 (11.2) |  < 0.001 |
 1.5–3 × ULN | 6 (0.9) | 15 (8) |  < 0.001 |
  > 3 × ULN | 0 | 6 (3.2) |  < 0.001 |
AST elevation | 3 (0.5) | 8 (4.3) |  < 0.001 |
 3–5 × ULN | 3 (0.5) | 6 (3.2) |  < 0.001 |
  > 5 × ULN | 0 | 2 (1.1) | 0.05 |
ALT elevation | 5 (0.8) | 3 (1.6) | 0.39 |
 3–5 X ULN | 3 (0.5) | 2 (1.1) | 0.32 |
  > 5 × ULN | 2 (0.3) | 1 (0.5) | 0.54 |