Table 1.
Patient demographics and baseline characteristics (FAS)
| Parameter | LA-EP2006 (N=314) | Reference pegfilgrastim (N=310) | Total (N=624) |
|---|---|---|---|
| Age, years | |||
| n | 314 | 310 | 624 |
| Mean (SD) | 49.3 (10.02) | 49.8 (10.49) | 49.6 (10.25) |
| Median (range) | 50.0 (25–75) | 50.0 (26–76) | 50.0 (25–76) |
| BMI, kg/m2 | |||
| N | 313 | 309 | 622 |
| Mean (SD) | 27.1 (5.72) | 27.0 (5.38) | 27.0 (5.55) |
| Median (range) | 26.4 (14–44) | 26.2 (15–47) | 26.2 (14–47) |
| Race, n (%) | |||
| White | 219 (69.7) | 220 (71.0) | 439 (70.4) |
| Asian | 90 (28.7) | 84 (27.1) | 174 (27.9) |
| Black or African American | 1 (0.3) | 2 (0.6) | 3 (0.5) |
| Othera | 4 (1.3) | 4 (1.3) | 8 (1.3) |
| Ethnicity, n (%) | |||
| Not Hispanic or Latino | 293 (93.3) | 286 (92.3) | 579 (92.8) |
| Hispanic or Latino | 21 (6.7) | 24 (7.7) | 45 (7.2) |
| Time since initial diagnosis (months) | |||
| N | 308 | 298 | 606 |
| Median (range) | 1.33 (0.1–76.0) | 1.35 (0.2–11.2) | 1.35 (0.1–76.0) |
| Stage at initial diagnosis, n (%) | |||
| I | 11 (3.5) | 16 (5.2) | 27 (4.3) |
| II | 144 (45.9) | 134 (43.2) | 278 (44.6) |
| III | 159 (50.6) | 156 (50.3) | 315 (50.5) |
| IV | 0 | 4 (1.3) | 4 (0.6) |
| Any breast cancer surgical procedure, n (%) | 303 (96.5) | 298 (96.1) | 601 (96.3) |
| Any prior radiotherapy, n (%) | 9 (2.9) | 10 (3.2) | 19 (3.0) |
| ECOG coding at screening, n (%) | |||
| 0 | 245 (78.0) | 233 (75.2) | 478 (76.6) |
| 1 | 67 (21.3) | 77 (24.8) | 144 (23.1) |
| 2 | 2 (0.6) | 0 | 2 (0.3) |
a
Other race specified as Mestizo, Parda or Hispanic.
BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; FAS, full analysis set; N, number of patients in a treatment group or analysis set; n, number of assessable patients; SD, standard deviation.