Table 2.
Characteristics of the study populations
| Study | Age (y) | Body weight (kg) | BMI (kg/m2) | BSA (m2) | ALB (g/L) | CrCLa (mL/min) | ALT (IU/L) | AST (IU/L) | BILI (μmol/L) | HCT | Hb (g/L) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| C15001 | 59.5 (34–84) | 81.1 (45.7–148) | 28.8 (20.2–45.8) | 1.98 (1.38–2.72) | 35 (21–50) | 99.1 (45.9–251) | 25.5 (10–87) | 26 (12–60) | 8.55 (1.71–18.8) | 0.346 (0.214–0.485) | 116 (9.9–163) |
| C15002 | 60 (26–90) | 80.1 (51.4–141) | 27.3 (18.9–41.5) | 1.93 (1.48–2.69) | 39 (26–50) | 94.3 (42.3–175) | 18 (6–134) | 25 (13–110) | 6.84 (1.71–17.1) | 0.342 (0.239–0.435) | 112 (83–153) |
| C15003 | 65 (23–84) | 74.1 (48.6–180) | 26 (15.7–55.5) | 1.86 (1.43–3) | 37 (25–48) | 79 (42.1–301) | 27 (8–98) | 25 (7–76) | 8.55 (3.42–18.8) | 0.266 (0.196–0.383) | 91 (70–127) |
| C15005 | 62.1 (32.6–79.4) | 83.5 (52–129) | 28.2 (18.1–41.6) | 2.01 (1.49–2.54) | 39.6 (29–44) | 104 (58.3–216) | 15.5 (6–49) | 19.5 (10–55) | 6.84 (3.42–17.1) | 0.36 (0.255–0.5) | 120 (86–172) |
| C15009 b | 75 (61–89) | 71.9 (43.5–128) | 25.6 (17.6–40.3) | 1.84 (1.38–2.54) | NR | 65.8 (26.3–186) | 25 (6–114) | 21.5 (11–95) | 11.1 (1.71–37.6) | NR | NR |
| C15010 | 61 (26–84) | 77.1 (44.7–150) | 25.6 (16.9–43.8) | 1.92 (1.42–2.78) | NR | 97.9 (49.8–250) | 23 (7–67) | 25 (10–81) | 6.84 (1.71–18.8) | NR | NR |
ALB, albumin; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BILI, total bilirubin; BMI, body mass index; BSA, body surface area; CrCL, creatinine clearance; Hb, haemoglobin; HCT, haematocrit; NR, not reported.
Data are presented as median (range).
a
Cockcroft–Gault formula was used to estimate creatinine clearance: for men (140 – age) (weight in kg)/72 × serum creatinine; for women, this result is multiplied by the factor of 0.85.
b
Only 1 subject was severely renally impaired at baseline, and renal function worsened to severe status in 4 other subjects.