Table 1.
Patient demographics and characteristics
| Characteristic | Study 1 (n = 66) | Study 2 (n = 33) | Study 3 (n = 50) | Pediatric IIR (n = 14) | Total (N = 163) |
|---|---|---|---|---|---|
| Number of PK samples | 281 | 123 | 283 | 110 | 797 |
| Male, n (%) | 36 (54.55) | 20 (60.61) | 30 (60) | 9 (64.29) | 95 (58.28) |
| Race, n (%) | |||||
| White | 52 (78.79) | 26 (78.79) | 48 (96) | 10 (71.43) | 136 (83.44) |
| Black | 1 (1.52) | 4 (12.12) | 1 (2) | 4 (28.57) | 10 (6.13) |
| Asian | 6 (9.09) | 2 (6.06) | 0 (0) | 0 (0) | 8 (4.91) |
| Other | 7 (10.61) | 1 (3.03) | 0 (0) | 0 (0) | 8 (4.91) |
| Missing | 0 (0) | 0 (0) | 1 (2) | 0 (0) | 0 (0) |
| Age, years | |||||
| Mean (SD) | 5.9 (5.14) | 53.2 (18.83) | 58.2 (13.74) | 82.1 (124.10) a | 31.0 (28.38) |
| Median (range) | 4 (0.10–17) | 59 (20–81) | 58.5 (25–80) | 26.3 (1.8–451.1) a | 21 (1.8 a –81) |
| Body weight, kg | |||||
| Mean (SD) | 23.0 (19.09) | 77.8 (19.37) | 73.8 (27.31) | 3.2 (2.61) | 48.0 (35.51) |
| Median (range) | 16.6 (2.31–85.7) | 77.2 (37.8–122.1) | 70.0 (48.0–240.0) | 2.8 (0.75–9.47) | 54.0 (0.75–240.0) |
PK, pharmacokinetics; SD, standard deviation.
a
Age, days.