Table 6 Pharmacodynamic geometric mean ratios of AVI-014/filgrastim at 8 μg/kg
Hematologic | Parameter | Dose μg/kg | Geometric Mean AVI-014 (n = 8) | Geometric Mean Filgrastin (n = 8) | P value | Geometric Mean Ratio (90% CI) |
|---|---|---|---|---|---|---|
WBC | AUC(0–9) | 8 | 1444.7 | 1574.1 | 0.3824 | 0.92 (0.78, 1.09) |
Cmax | 8 | 415.9 | 435.7 | 0.6617 | 0.95 (0.79, 1.15) | |
ANC | AUC(0–9) | 8 | 1974.4 | 2268.9 | 0.4626 | 0.87 (0.63, 1.21) |
Cmax | 8 | 661.3 | 739.6 | 0.6230 | 0.89 (0.60, 1.34) | |
CD 34+ | AUC(0–6) | 8 | 3121.6 | 2791.2 | 0.8785 | 1.12 (0.31, 3.99) |
Cmax | 8 | 1373.2 | 1315.9 | 0.9569 | 1.04 (0.26, 4.11) |