PK parameters
| . | Group 1 ≥12 y to <18 y n = 14 . | Group 2 ≥6 y to <12 y n = 11 . | Group 3 ≥2 y to <6 y n = 15 . | All patients N = 40 . |
|---|---|---|---|---|
| AUClast(ng∗h/mL) | ||||
| n | 5 | 10 | 15 | 30 |
| Mean (SD) | 412 (403) | 365 (195) | 286 (166) | 333 (224) |
| CV% | 97.9 | 53.6 | 58.2 | 67.2 |
| Geo-mean | 252 | 311 | 249 | 269 |
| Geo-CV% | 186.6 | 70.2 | 56.9 | 78.2 |
| Median (range) | 358 (45.1-1070) | 337 (105-676) | 231 (94.8-702) | 267 (45.1-1070) |
| Cmax(ng/mL) | ||||
| n | 5 | 10 | 15 | 30 |
| Mean (SD) | 96.3 (68.5) | 110 (72.7) | 78.1 (58.8) | 91.7 (64.6) |
| CV% | 71.2 | 66.2 | 75.3 | 70.5 |
| Geo-mean | 66.1 | 90.3 | 64.0 | 72.2 |
| Geo-CV% | 169.8 | 74.6 | 67.5 | 83.8 |
| Median (range) | 102 (9.9-184) | 72.5 (36.3-257) | 58.4 (31.1-229) | 69.4 (9.9-257) |
| Ctrough(ng/mL) | ||||
| n | 7 | 8 | 14 | 29 |
| Mean (SD) | 22.1 (38.7) | 14.3 (17.6) | 8.7 (12.7) | 13.5 (22.4) |
| CV% | 175.3 | 122.4 | 146.0 | 166.4 |
| Geo-mean | 9.27 | 6.31 | 4.79 | 6.07 |
| Geo-CV% | 379.4 | 266.0 | 225.1 | 252.1 |
| Median (range) | 6.1 (0.0-108) | 5.6 (1.3-48.8) | 3.4 (0.0-44.3) | 4.33 (0.0-108) |
| T1/2(h) | ||||
| n | 2 | 7 | 10 | 19 |
| Mean (SD) | 1.36 (0.414) | 1.63 (0.259) | 1.99 (0.873) | 1.79 (0.682) |
| CV% | 30.5 | 15.8 | 43.9 | 38.1 |
| Geo-mean | 1.33 | 1.62 | 1.82 | 1.68 |
| Geo-CV% | 31.7 | 15.4 | 47.1 | 36.3 |
| Median (range) | 1.36 (1.07-1.65) | 1.58 (1.31-2.12) | 1.85 (0.998-3.40) | 1.58 (0.998-3.40) |
| . | Group 1 ≥12 y to <18 y n = 14 . | Group 2 ≥6 y to <12 y n = 11 . | Group 3 ≥2 y to <6 y n = 15 . | All patients N = 40 . |
|---|---|---|---|---|
| AUClast(ng∗h/mL) | ||||
| n | 5 | 10 | 15 | 30 |
| Mean (SD) | 412 (403) | 365 (195) | 286 (166) | 333 (224) |
| CV% | 97.9 | 53.6 | 58.2 | 67.2 |
| Geo-mean | 252 | 311 | 249 | 269 |
| Geo-CV% | 186.6 | 70.2 | 56.9 | 78.2 |
| Median (range) | 358 (45.1-1070) | 337 (105-676) | 231 (94.8-702) | 267 (45.1-1070) |
| Cmax(ng/mL) | ||||
| n | 5 | 10 | 15 | 30 |
| Mean (SD) | 96.3 (68.5) | 110 (72.7) | 78.1 (58.8) | 91.7 (64.6) |
| CV% | 71.2 | 66.2 | 75.3 | 70.5 |
| Geo-mean | 66.1 | 90.3 | 64.0 | 72.2 |
| Geo-CV% | 169.8 | 74.6 | 67.5 | 83.8 |
| Median (range) | 102 (9.9-184) | 72.5 (36.3-257) | 58.4 (31.1-229) | 69.4 (9.9-257) |
| Ctrough(ng/mL) | ||||
| n | 7 | 8 | 14 | 29 |
| Mean (SD) | 22.1 (38.7) | 14.3 (17.6) | 8.7 (12.7) | 13.5 (22.4) |
| CV% | 175.3 | 122.4 | 146.0 | 166.4 |
| Geo-mean | 9.27 | 6.31 | 4.79 | 6.07 |
| Geo-CV% | 379.4 | 266.0 | 225.1 | 252.1 |
| Median (range) | 6.1 (0.0-108) | 5.6 (1.3-48.8) | 3.4 (0.0-44.3) | 4.33 (0.0-108) |
| T1/2(h) | ||||
| n | 2 | 7 | 10 | 19 |
| Mean (SD) | 1.36 (0.414) | 1.63 (0.259) | 1.99 (0.873) | 1.79 (0.682) |
| CV% | 30.5 | 15.8 | 43.9 | 38.1 |
| Geo-mean | 1.33 | 1.62 | 1.82 | 1.68 |
| Geo-CV% | 31.7 | 15.4 | 47.1 | 36.3 |
| Median (range) | 1.36 (1.07-1.65) | 1.58 (1.31-2.12) | 1.85 (0.998-3.40) | 1.58 (0.998-3.40) |
PK analysis set. N is the number of patients with corresponding evaluable PK parameters.
AUClast, AUC to last quantifiable concentration; Cmax, maximum plasma concentration; Ctrough, trough plasma concentration; CV%, coefficient of variation; Geo-mean, geometric mean; Geo-CV%, geometric coefficient of variation; SD, standard deviation; T1/2 half-life.