| |
Proposed biosimilar pegfilgrastim (APO-Peg) (N = 294)
|
US-licensed pegfilgrastim reference product (US-Neulasta®) (N = 148)
|
EU-approved pegfilgrastim reference product (EU-Neulasta®) (N = 147)
|
Total (N = 589)
|
|---|
|
Demographic data
|
|
Female, n (%)
|
294 (100)
|
148 (100)
|
147 (100)
|
589 (100)
|
|
Age (years)
|
|
Mean (SD)
|
51.9 (10.0)
|
51.4 (10.4)
|
51.5 (10.2)
|
51.7 (10.1)
|
|
Median (min, max)
|
52.0 (24.0, 75.0)
|
52.0 (27.0, 80.0)
|
53.0 (22.0, 77.0)
|
52.0 (22.0, 80.0)
|
|
Race, n (%) Caucasian
|
294 (100.0)
|
148 (100.0)
|
147 (100.0)
|
589 (100.0)
|
|
Body weight (kg)
|
|
Mean (SD)
|
73.88 (14.4)
|
72.01 (14.1)
|
72.61 (12.9)
|
73.09 (14.0)
|
|
Median (min, max)
|
73.0 (40.0, 120.0)
|
70.0 (40.0, 118.0)
|
70.0 (48.0, 119.0)
|
72.0 (40.0, 120.0)
|
|
Body height (cm)
|
|
Mean (SD)
|
162.5 (6.8)
|
162.7 (6.6)
|
162.6 (6.4)
|
162.6 (6.6)
|
|
Median (min, max)
|
163.0 (140.0, 180.0)
|
163.0 (142.0, 180.0)
|
163.0 (148.0, 183.0)
|
163.0 (140.0, 183.0)
|
|
Breast cancer history
|
|
Tumor parameter
|
|
Staging IIA
|
129 (43.9)
|
59 (39.9)
|
58 (39.5)
|
246 (41.8)
|
|
Staging IIB
|
79 (26.9)
|
40 (27.0)
|
44 (29.9)
|
163 (27.7)
|
|
Staging IIIA
|
86 (29.3)
|
49 (33.1)
|
45 (30.6)
|
180 (30.6)
|
- T1, T2, T3 means the size and/or extent of the primary tumor stage (increasing order from 1 to 3)
