Table 1.

Summary of demographic and baseline characteristics for patients in the full analysis set (FAS)

		Pegfilgrastim		Placebo
		(n = 173)		(n = 173)
		n	%	n	%
Age (years)	Median	51.0		50.0
	Range	26–69		27–69
	<65	153	88.4	156	90.2
	≥65	20	11.6	17	9.8
Body weight (kg)	Mean (SD)	56.0 (9.9)		55.0 (7.6)
	<60	123	71.1	131	75.7
	≥60	50	28.9	42	24.3
Body surface area (m2)	Mean (SD)	1.55 (0.13)		1.54 (0.11)
Chemotherapy	Neoadjuvant	24	13.9	22	12.7
	Adjuvant	149	86.1	151	87.3
Primary disease	Infiltrating ductal carcinoma	158	91.3	153	88.4
	Special type	12	6.9	19	11.0
	Other	3	1.7	1	0.6
Clinical stage	I	64	37.0	56	32.4
	II	97	56.1	105	60.7
	III	12	6.9	12	6.9
Lymph node involvement	pN0	101	58.4	94	54.3
	pN (+)	72	41.6	77	44.5
	Unknown	0	0.0	2	1.2
Hormone receptor status	ER negative	35	20.2	42	24.3
	ER positive	138	79.8	131	75.7
	PgR negative	60	34.7	60	34.7
	PgR positive	113	65.3	113	65.3
	HER2 negative	60	34.7	60	34.7
	HER2 positive	113	65.3	113	65.3

ER estrogen receptor, PgR progesterone receptor, HER2 human epidermal growth factor receptor 2, SD standard deviation