Table 5 Pharmacodynamic geometric mean ratios of AVI-014/filgrastim at 4 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) | 4 | 1343.9 | 1193.6 | 0.1473 | 1.13 (0.98, 1.29) |
Cmax | 4 | 375.1 | 326.7 | 0.1737 | 1.15 (0.97, 1.36) | |
ANC | AUC(0–9) | 4 | 2146.3 | 1560.3 | 0.0489 | 1.38 (1.06, 1.78) |
Cmax | 4 | 735.9 | 515.8 | 0.0690 | 1.43 (1.04, 1.96) | |
CD 34+ | AUC(0–6) | 4 | 3208.8 | 3088.9 | 0.9613 | 1.04 (0.27, 4.06) |
Cmax | 4 | 1322.7 | 1186.3 | 0.8875 | 1.12 (0.29, 4.24) |