Table 1.
Demographics and baseline clinical characteristics
| Phase I (n = 68) | Phase II (n = 157) | Total (N = 225) | |
|---|---|---|---|
| Age, years | |||
| Mean (CV%) | 36.2 (22.7) | 64.1 (19.8) | 55.7 (30.9) |
| Median (range) | 36.0 (20.0–49.0) | 66.0 (22.0–83.0) | 60.0 (20.0–83.0) |
| Sex, n (%) | |||
| Male | 38 (55.9) | 45 (28.7) | 83 (36.9) |
| Female | 30 (44.1) | 112 (71.3) | 142 (63.1) |
| Race, n (%) | |||
| White | 34 (50.0) | 142 (90.4) | 176 (78.2) |
| Black | 2 (1.27) | 2 (0.889) | |
| Asian | 34 (50.0) | 10 (6.37) | 44 (19.6) |
| Native Hawaiian or other Pacific Islander | 2 (1.27) | 2 (0.889) | |
| Other | 1 (0.637) | 1 (0.444) | |
| Height, cm | |||
| Mean (CV%) | 168 (5.06) | 166 (5.19) | 166 (5.17) |
| Median (range) | 168 (151–183) | 165 (145–190) | 166 (145–190) |
| Weight, kg | |||
| Mean (CV%) | 68.3 (16.7) | 71.0 (23.9) | 70.2 (22.1) |
| Median (range) | 64.9 (49.5–95.9) | 68.0 (40.4–155) | 67.5 (40.4–155) |
| BMI, kg/m2 | |||
| Mean (CV%) | 24.2 (12.8) | 25.8 (20.5) | 25.3 (18.9) |
| Median (range) | 24.5 (18.4–29.9) | 25.0 (18.3–53.8) | 24.7 (18.3–53.8) |
| BSA, m2 | |||
| Mean (CV%) | 1.77 (9.73) | 1.78 (12.2) | 1.78 (11.5) |
| Median (range) | 1.75 (1.46–2.16) | 1.75 (1.28–2.54) | 1.75 (1.28–2.54) |
| CLcr, mL/min/1.73 m2 | |||
| Mean (CV%) | 98.3 (16.7) | 67.6 (28.6) | 76.9 (30.2) |
| Median (range) | 99.1 (65.4–149) | 65.0 (26.7–129) | 75.6 (26.7–149) |
BMI body mass index, BSA body surface area, CLcr creatinine clearance, CV coefficient of variation