Table 2.
Summary of continuous patient characteristics at the time of the first dose for patients in the population pharmacokinetic analysis
| Age (years) | Weight (kg) | LBM (kg) | BSA (m2) | CGCLa (mL/min) | ALT (U/L) | AST (U/L) | Bilirubin (µmol/L) | |
|---|---|---|---|---|---|---|---|---|
| All five studies JFCA/B/C/I/J | ||||||||
| N | 807 | 807 | 796 | 796 | 799 | 804 | 801 | 802 |
| N miss | 0 | 0 | 11 | 11 | 8 | 3 | 6 | 5 |
| Minimum | 19 | 35.0 | 28.2 | 1.23 | 36.0 | 1.40 | 4.90 | 0.300 |
| Median | 62 | 71.0 | 50.8 | 1.82 | 90.1 | 19.0 | 20.0 | 7.00 |
| Maximum | 84 | 181 | 90.4 | 2.81 | 751 | 387 | 216 | 30.8 |
| Geometric mean | 60.4 | 70.8 | 50.4 | 1.81 | 90.3 | 20.3 | 21.0 | 6.92 |
| Geometric CV % | 16 | 22 | 16 | 12 | 37 | 73 | 54 | 60 |
ALT alanine aminotransferase, AST aspartate aminotransferase, BSA body surface area, CGCL Cockcroft–Gault creatinine clearance, CV coefficient of variance, LBM lean body mass, N miss Number of missing
aFor the population pharmacokinetic analysis, CGCL values >250 mL/min were set to 250 mL/min, resulting in a geometric mean (CV %) of 89.9 (35 %)