Table 2.
Summary of efficacy endpoints by cycle and group (FAS)
| Cycle | F-627 20 mg |
Filgrastim 5 µg/kg/day |
(F-627 − Filgrastim) (95% CI) |
P |
|---|---|---|---|---|
| Primary efficacy endpoint | ||||
| The duration in days of grade 3 or 4 neutropenia in Cycle1, mean ± SD (day) | ||||
| 1 | 0.68 ± 1.10 | 0.71 ± 0.95 | 0.0 (0.00, 0.00) | – |
| Secondary efficacy endpoints | ||||
| The duration in days of grade 3 or 4 neutropenia in Cycle2-4, mean ± SD (day) | ||||
| 2 | 0.1 ± 0.35 | 0.1 ± 0.25 | 0.0 (0.00, 0.00) | – |
| 3 | 0.0 ± 0.18 | 0.2 ± 0.54 | 0.0 (0.00, 0.00) | – |
| 4 | 0.1 ± 0.38 | 0.1 ± 0.41 | 0.0 (0.00, 0.00) | – |
| The incidence of grade 3 or 4 neutropenia in each Cycle, n/N (%) | ||||
| 1 | 41/120 (34.2) | 51/119(42.9) | – | 0.185 |
| 2 | 7/117 (6.0) | 7/107 (6.5) | – | > 0.999 |
| 3 | 4/115 (3.5) | 18/103 (17.5) | – | < 0.001 |
| 4 | 10/114 (8.8) | 10/101 (9.9) | – | 0.817 |
| The duration in days of grade 4 neutropenia in each Cycle, mean ± SD (day) | ||||
| 1 | 0.3 ± 0.69 | 0.2 ± 0.58 | 0.0 (0.00, 0.00) | – |
| 2 | 0.0 ± 0.13 | 0.0 ± 0.10 | 0.0 (0.00, 0.00) | – |
| 3 | 0.0 ± 0.00 | 0.1 ± 0.34 | 0.0 (0.00, 0.00) | – |
| 4 | 0.0 ± 0.13 | 0.0 ± 0.20 | 0.0 (0.00, 0.00) | – |
| The incidence of grade 4 neutropenia in each Cycle, n/N (%) | ||||
| 1 | 17/120 (14.2) | 19/119 (16.0) | – | 0.721 |
| 2 | 2/117 (1.7) | 1/107 (0.9) | – | > 0.999 |
| 3 | 0/115 (0) | 4/103 (3.9) | – | 0.048 |
| 4 | 2/114 (1.8) | 4/101 (4.0) | – | 0.432 |
| The depth of ANC nadir, mean ± SD (× 109/L) | ||||
| 1 | 2.059 ± 1.502 | 1.603 ± 1.206 | 0.3 (0.04, 0.65) | – |
| 2 | 3.704 ± 1.935 | 2.520 ± 1.137 | 1.1 (0.67, 1.51) | – |
| 3 | 3.347 ± 1.663 | 2.230 ± 1.142 | 1.0 (0.60, 1.34) | – |
| 4 | 2.967 ± 1.610 | 2.182 ± 0.980 | 0.7 (0.30, 1.01) | – |
Abbreviations: ANC Absolute neutrophil counts, SD Standard deviation