Table 2.

Unadjusted incidence rates of severe uterine bleeding in the atrial fibrillation population by treatment exposure group during the primary and sensitivity observation periods

Exposure	Database	Patientsa	On-treatment			On-treatment (30-day gap)					Intent-to-treat
			Events	PYs	IR/1000 PYs	IP/1000 P	Events	PYs	IR/1000 PYs	IP/1000 P	Events	PYs	IR/1000 PYs	IP/1000 P
Rivaroxaban	CCAE	7518	19	1907	9.96	2.53	60	4957	12.10	7.98	128	12,849	9.96	17.03
	MDCD	2621	5	558	8.96	1.91	15	1506	9.96	5.72	29	4738	6.12	11.06
	MDCR	14,807	18	4919	3.66	1.22	46	13,078	3.52	3.10	86	30,582	2.81	5.81
	Optum	21,858	36	6824	5.28	1.65	88	18,555	4.74	4.03	170	48,505	3.51	7.78
Apixaban	CCAE	8243	12	2202	5.45	1.46	41	5950	6.89	4.97	95	11,993	7.92	11.53
	MDCD	3356	0	696	0.00	0.00	7	1773	3.95	2.09	25	4332	5.77	7.45
	MDCR	18,477	12	6211	1.93	0.65	32	16,318	1.96	1.73	62	29,717	2.09	3.36
	Optum	39,601	38	12,535	3.03	0.96	82	33,327	2.46	2.07	143	67,128	2.13	3.61
Dabigatran	CCAE	4188	5	964	5.18	1.19	18	2357	7.64	4.30	66	8397	7.86	15.76
	MDCD	743	0	164	0.00	0.00	2	483	4.14	2.69	5	2132	2.35	6.73
	MDCR	8567	8	2564	3.12	0.93	25	6898	3.62	2.92	56	22,877	2.45	6.54
	Optum	7513	4	1984	2.02	0.53	18	6263	2.87	2.40	68	23,194	2.93	9.05
Warfarin	CCAE	8792	21	2556	8.21	2.39	41	4610	8.89	4.66	128	15,988	8.01	14.56
	MDCD	5527	8	1520	5.26	1.45	15	2972	5.05	2.71	63	13,677	4.61	11.40
	MDCR	28,227	18	9279	1.94	0.64	29	17,933	1.62	1.03	113	63,648	1.78	4.00
	Optum	41,201	30	15,866	1.89	0.73	70	33,485	2.09	1.70	213	115,352	1.85	5.17

CCAE IBM MarketScan^® Commercial Database, IP incidence proportion, IR incidence rate, MDCD IBM MarketScan^® Multi-state Medicaid, MDCR IBM MarketScan^® Medicare Supplemental Beneficiaries, P patients, PYs patient-years

^aThe unadjusted IR denominator is restricted to patients with ≥ 1 day time-at-risk