Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy

Table 2 Duration of severe neutropenia in cycles 1–4 (per-protocol population)

	Cycle 1 (primary endpoint)		Cycle 2		Cycle 3		Cycle 4
	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg
Mean ± SD	0.8 ± 0.9	0.7 ± 0.9	0.3 ± 0.6	0.1 ± 0.5	0.2 ± 0.4	0.1 ± 0.3	0.2 ± 0.5	0.2 ± 0.6
Median (range)	1 (0.0, 4.0)	0 (0.0, 4.0)	0 (0.0, 3.0)	0 (0.0, 3.0)	0 (0.0, 2.0)	0 (0.0, 2.0)	0 (0.0, 3.0)	0 (0.0, 3.0)
LS Mean (95% CI)^*	−0.218 (−0.498%, 0.062%)		−0.123 (−0.282%, 0.036%)		−0.029 (−0.145%, 0.087%)		0.008 (−0.147%, 0.163%)
p value^†	0.1260		0.1287		0.6227		0.922

^*Least-squares mean comparison of lipegfilgrastim versus pegfilgrastim by Poisson regression with treatment, country, type of therapy, and weight class as class variables and absolute neutrophil count baseline as a covariable. Poisson regression with possible overdispersion.
^† p value is based on null hypothesis of equality.
CI confidence interval, LS least-squares, SD standard deviation.

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