Skip to main content

Advertisement

Table 2 Summary of DSN in cycle 1 (FAS-As Randomized and FAS-As Treated)

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

Analysis Set Statistic Proposed biosimilar pegfilgrastim (APO-Peg) US-licensed pegfilgrastim reference product (US-Neulasta®) EU-approved pegfilgrastim reference product (EU-Neulasta®) (APO-Peg)-minus (US-Neulasta®) (APO-Peg)-minus (EU-Neulasta®) (EU-Neulasta®) minus (US-Neulasta®)
FAS (As Randomized)
 N 294 148 147 N/A N/A N/A
 LS Mean in days 1.6 1.4 1.6 0.2 0.02 0.2
 Median (Min, Max) in days 2.0 (0, 10) 1.0 (0, 5) 2.0 (0, 10) N/A N/A N/A
 95% CI in days 1.47 to 1.79 1.17 to 1.61 1.38 to 1.83 − 0.03 to 0.51 − 0.25 to 0.30 − 0.10 to 0.53
FAS (As Treated)
 N 298 147 144 N/A N/A N/A
 LS Mean in days 1.6 1.4 1.6 0.2 -0.01 0.2
 Median (Min, Max) in days 1.5 (0, 10) 1.0 (0, 5) 2.0 (0, 10) N/A N/A N/A
 95% CI in days 1.46 to 1.77 1.17 to 1.61 1.41 to 1.86 − 0.04 to 0.50 − 0.29 to 0.26 − 0.07 to 0.56