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 3 Incidence of severe neutropenia in cycles 1–4 (per-protocol population)^*

	Cycle 1		Cycle 2		Cycle 3		Cycle 4		Across all cycles
	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg
n/N	48/94	41/94	20/93	8/94	11/91	8/93	11/91	11/90	55/94	47/94
(%)	(51.1)	(43.6)	(21.5)	(8.5)	(12.1)	(8.6)	(12.1)	(12.2)	(58.5)	(50.0)
OR (95% CI)	0.745 (0.405%, 1.369%)		0.291 (0.110%, 0.769%)		0.676 (0.249%, 1.835%)		0.997 (0.391%, 2.545%)		0.708 (0.383%, 1.309%)
p value^†	0.3409		0.0130		0.4404		0.9958		0.2695

^*Multiple mentions per patient are possible.
^†Pegfilgrastim 6 mg vs. lipegfilgrastim 6 mg (p values are based on a null hypothesis of OR = 1).
CI confidence interval, OR odds ratio.

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