Table 3.

Gastrointestinal (GI) side effects and polyps by randomized aspirin assignment after extended follow-up in the Women’s Health Study.

	Cases (%)
	Aspirin (N=19,934)	Placebo (N=19,942)	Hazard Ratio	95% CI	P Value	P trial vs. post- trial
OVERALL
Reported GI bleed	1645 (8.3)	1452(7.3)	1.14	1.06-1.22	<0.001	0.37
Reported peptic ulcer	1456 (7.3)	1242 (6.2)	1.17	1.09-1.27	<0.001	0.29
Reported colon polyp	5187 (26.0)	5151 (25.8)	1.00	0.96-1.04	0.94	0.145
TRIAL
Reported GI bleed	1489 (7.5)	1301 (6.5)	1.15	1.07-1.24	<0.001
Reported peptic ulcer	1115 (5.6)	931 (4.7)	1.20	1.10-1.31	<0.001
Reported colon polyp	2901 (14.6)	2967 (14.9)	0.97	0.92-1.02	0.31
POST-TRIAL
Reported GI bleed	156 (0.9)	151 (0.9)	1.03	0.82-1.29	0.79
Reported peptic ulcer	341 (2.0)	311 (1.8)	1.09	0.94-1.28	0.26
Reported colon polyp	2286 (14.6)	2184 (14.0)	1.03	0.97-1.09	0.29