Table 3.
Baseline hepatic function characteristics in the pharmacokinetics population, by hepatic function group
| Characteristic | Mild HI (n = 9) | Healthy match, mild HI (n = 9) | Moderate HI (n = 8) | Healthy match, moderate HI (n = 10) |
|---|---|---|---|---|
| Median Child-Pugh Score (range) | 5.0 (5–6) | NA | 7.0 (7–8) | NA |
| Hepatic encephalopathy grade: none / 1–2 [n (%)] | 8 (89) / 1 (11) | 9 (100) / 0 | 4 (50) / 4 (50) | 10 (100) / 0 |
| Ascites: absent / mild / moderate [n (%)] | 8 (89) / 1(11) / 0 | 9 (100) / 0 / 0 | 2 (25) / 4 (50) / 2 (25) | 10 (100) / 0 / 0 |
| Median bilirubin [mg dl−1 (range)] | 0.80 (0.5–1.8) | 0.70 (0.4–1.8) | 1.55 (1.3–2.8) | 0.75 (0.5–1.0) |
| Median albumin [g dl−1 (range)] | 4.20 (3.6–4.7) | 4.30 (4.1–4.8) | 3.60 (2.2–4.2) | 4.40 (4.1–4.9) |
| Median prothrombin time [s (range)] | 11.70 (10.3–14.3) | 12.60 (10.3–13.8) | 14.70 (11.6–16.6) | 10.90 (10.0–13.0) |
| Median INR (range) | 1.00 (0.9–1.2) | 1.00 (1.0–1.1) | 1.30 (1.1–1.4) | 1.00 (0.9–1.0) |
Abbreviations are as follows: HI, hepatic impairment; INR, international normalized ratio; and NA, not applicable.