Population Pharmacokinetic Analysis of Selumetinib and Its N-desmethyl Metabolite in Japanese and Non-Japanese Pediatric Patients with Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas
Table 2
Summary of patient demographics and other baseline characteristics.
Item
D1346C00013
SPRINT
Total
N = 12
N = 68
N = 80
Age (years)
13.25 (7.5–18.2)
10.20 (3.0–18.5)
10.55 (3.0–18.5)
Weight (kg)
34.00 (20.7–58.9)
29.55 (15.7–88.7)
30.09 (15.7–88.7)
BSA (m2)
1.185 (0.82–1.57)
1.040 (0.67–2.01)
1.059 (0.67–2.01)
CrCL (mL/min/1.73 m2)
188.55 (126.6–275.7)
194.43 (128.4–363.4)
192.01 (126.6–363.4)
Bilirubin (mg/dL)
0.605 (0.31–1.33)
0.410 (0.21–1.23)
0.492 (0.21–1.33)
AST (µkat/L)
0.300 (0.19–0.39)
0.342 (0.12–1.90)
0.333 (0.12–1.90)
ALT (µkat/L)
0.156 (0.10–0.30)
0.275 (0.10–0.77)
0.233 (0.10–0.77)
Albumin (g/L)
44.0 (42–47)
42.0 (35–49)
42.0 (35–49)
Sex
Female
9 (75.0%)
30 (44.1%)
39 (48.8%)
Male
3 (25.0%)
38 (55.9%)
41 (51.2%)
Race
Japanese
12 (100.0%)
0 (0.0%)
12 (15.0%)
White
0 (0.0%)
56 (82.4%)
56 (70.0%)
Black
0 (0.0%)
5 (7.4%)
5 (6.2%)
Asian-Other
0 (0.0%)
3 (4.4%)
3 (3.8%)
Missing
0 (0.0%)
4 (5.9%)
4 (5.0%)
Data are presented as the median (range) for continuous items and as n (%) for categorical items. Asian-Other represents Asian Other than Japanese, Chinese, and Indian. ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSA, body surface area; CrCL, creatinine clearance.
