. Author manuscript; available in PMC: 2013 Jun 3.

Published in final edited form as: Arch Intern Med. 2009 Oct 12;169(18):1684–1691. doi: 10.1001/archinternmed.2009.303

Table 3.

Annualized rates and multivariable adjusted risk of invasive breast cancer due to new onset of breast tenderness at 12-month follow-up in the WHI E+P Trial

	Annualized rate of breast cancer

	Participants with new-onset breast tenderness		Participants with no new-onset breast tenderness
Treatment group	Cases (number at risk)	(%)¹	Cases (number at risk)	(%)	HR²	(95% CI)	P-value

All	83 (3231)	(0.56%)	209 (10149)	(0.34%)	1.29	(0.99, 1.70)	0.06
Placebo	15 (760)	(0.44%)	111 (5769)	(0.33%)	0.99	(0.59, 1.66)	0.97
CEE +MPA	68 (2471)	(0.60%)	98 (4380)	(0.36%)	1.48	(1.08, 2.03)	0.02

Annualized rates (unadjusted).

Hazard ratio from Cox proportional hazards models comparing risk of breast cancer among women with versus without new-onset breast tenderness. Cox proportional hazards models are adjusted for CEE+MPA randomization assignment, age, ethnicity, alcohol consumption, smoking, body mass index (linear and quartiles), physical activity (linear and quartiles), parity, age at first birth, breast feeding, years of age at menopause, Gail model breast cancer risk (linear and quartiles), and menopausal hormone therapy use prior to trial participation. This table displays hazard ratios for women without baseline breast tenderness.