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Table 1 Demographic and breast cancer history data—FAS (As Randomized)

From: Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

  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)
  1. T1, T2, T3 means the size and/or extent of the primary tumor stage (increasing order from 1 to 3)