Table 2:
Dosing characteristics, infusion volumes, and infusion flow rates
| Children (≥2 to <17 years) | Adults (≥17 years) | Total | ||||
|---|---|---|---|---|---|---|
| Main study (n = 38) |
Extension (n = 10) |
Main study (n = 37) |
Extension (n = 17) |
Main study (N = 75) |
Extension (N = 27) |
|
| Overall number of infusions (n) | 2213 | 1070 | 2249 | 1707 | 4462 | 2777 |
| Dose administered (g/kg BW/patient) | 0.16 ± 0.05 (0.06–0.29) |
0.17 ± 0.08 (0.06–0.30) |
0.19 ± 0.07 (0.09–0.39) |
0.17 ± 0.07 (0.07–0.38) |
0.17 ± 0.07 (0.06–0.39) |
0.17 ± 0.08 (0.06–0.38) |
| Average duration of infusion (active time only) [min] | 84.2 ± 45.9 (29.9–230.5) |
82.6 ± 28.4 (37.4–126.5) |
113.3 ± 48.4 (55.6–304.5) |
76.4 ± 39.8 (11.5–130.1) |
98.5 ± 49.1 (29.9–304.5) |
78.7 ± 35.6 (11.5–130.1) |
| Infusion volumes and flow rates per patient | ||||||
| Maximum volume administered (ml) weekly | 38.4 ± 20.2 (8.0–90.0) |
57.9 ± 29.5 (13.0–102.0) |
78.9 ± 31.6 (36.0–159.0) |
75.3 ± 38.1 (24.0–150.0) |
58.4 ± 33.2 (8.0–159.0) |
68.9 ± 35.6 (13.0–150.0) |
| Maximum infusion flow rate (ml/h) | 39.4 ± 11.1 (15.0–51.8) |
42.2 ± 12.9 (20.0–60.0) |
60.4 ± 17.5 (29.4–97.9) |
91.9 ± 28.3 (45.0–130.9) |
49.8 ± 17.9 (15.0–40.0) |
73.5 ± 33.9 (20.0–130.9) |
| Maximum infusion flow rate/site (ml/h/site) | 18.7 ± 6.0 (3.8–30.0) |
17.2 ± 4.9 (9.4–25.0) |
22.8 ± 9.5 (10.0–51.8) |
27.0 ± 8.3 (11.3–43.6) |
20.7 ± 8.1 (3.8–51.8) |
23.4 ± 8.6 (9.4–43.6) |
Data are mean ± SD, (range) except where indicated.
Abbreviations: BW, body weight.