Table 2.
Demographics summary for the population pharmacokinetic analysis dataset
| Variable | Study 102 (N = 43) | Study 103 (N = 24) | Study 110 (N = 16) | Study 201 (N = 192) | Study 301 (N = 417) | Study 302 (N = 370) | Overall (N = 1062) |
|---|---|---|---|---|---|---|---|
| AGE, year | 54.0 (29.0–63.0) | 51.5 (42.0–63.0) | 45.5 (22.0–63.0) | 55.9 (40.1–74.2) | 54.0 (27.0–73.0) | 55.0 (19.0–74.0) | 55.0 (19.0–74.2) |
| TBW, kg | 66.0 (45.0–89.0) | 68.5 (48.8–86.3) | 55.5 (47.2–82.0) | 68.0 (43.7–91.5) | 69.0 (40.0–104) | 70.0 (43.0–110) | 69.0 (40.0–110) |
| HT, cm | 166 (150–177) | 165 (150–179) | 159 (148–175) | 165 (145–182) | 165 (141–186) | 167 (145–185) | 165 (141–186) |
| BMI, kg/m2 | 24.1 (20.0–29.0) | 25.3 (20.1–28.9) | 23.1 (18.6–26.8) | 24.9 (19.2–30.4) | 25.4 (18.2–34.9) | 25.3 (18.6–34.9) | 25.2 (18.2–34.9) |
| RBC,1012/L | 4.78 (3.95–5.42) | 4.81 (3.96–6.03) | 4.05 (3.07–5.38) | 4.91 (2.81–6.92) | 4.90 (3.70–6.70) | 4.80 (3.70–6.10) | 4.85 (2.81–6.92) |
| ALB, g/L | 42.4 (36.7–47.5) | 42.5 (38.0–48.0) | 45.1 (33.2–49.5) | 45.6 (39.4–53.7) | 47.0 (39.0–56.0) | 47.0 (39.0–57.0) | 46.2 (33.2–57.0) |
| ALT, U/L | 17.0 (7.00–66.0) | 22.0 (9.00–50.0) | 12.0 (4.00–49.0) | 18.0 (2.50–61.0) | 20.0 (8.00–87.0) | 19.0 (6.00–110) | 19.0 (2.50–110) |
| AST, U/L | 18.0 (9.00–63.0) | 17.5 (11.0–45.0) | 16.0 (9.00–31.0) | 18.0 (10.0–53.0) | 18.0 (8.00–64.0) | 17.5 (9.00–74.0) | 18.0 (8.00–74.0) |
| GGT, U/L | 22.3 (11.4–91.7) | 31.0 (12.0–76.0) | 13.5 (7.00–113) | 27.0 (9.00–194) | 26.0 (8.00–334) | 21.0 (7.00–214) | 24.0 (7.00–334) |
| CR, μmol/L | 65.0 (39.9–99.5) | 67.1 (41.5–102) | 235 (42.0–943) | 64.0 (35.0–107) | 69.0 (36.0–111) | 67.0 (39.0–108) | 67.0 (35.0–943) |
| TBIL, μmol/L | 12.0 (6.00–24.6) | 15.9 (10.0–37.4) | 10.1 (4.30–15.2) | 8.75 (1.25–30.8) | 11.0 (3.00–29.0) | 10.0 (3.00–40.0) | 10.0 (1.25–40.0) |
| Sex, N (%) | |||||||
| Male | 20 (46.5%) | 17 (70.8%) | 6 (37.5%) | 117 (60.9%) | 269 (64.5%) | 236 (63.8%) | 665 (62.6%) |
| Female | 23 (53.5%) | 7 (29.2%) | 10 (62.5%) | 75 (39.1%) | 148 (35.5%) | 134 (36.2%) | 397 (37.4%) |
Continuous variables were presented by median (min–max); Categorical variables were presented by N (%)
AGE age, ALB albumin, ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, CR serum creatinine, GGT gamma–glutamyl transferase, HT height, RBC red blood cell count, TBIL total bilirubin, TBW total body weight