Table 2.

Characteristics of cases and non-cases, dabigatran or warfarin associated with hemorrhage events (SMQ20000038) limited by SOC for gastrointestinal disorder

Drug name			Age	Total	Cases	Non-cases	Rate	Reporting odds Ratio
			(year)	(n)	(n)	(n)	(%)	(95%CI)
	Dabigatran
		Reference
			0-29	291711	4274	287437	9.77	0.76	(	0.74	-	0.78	)
			30-39	216892	2525	214367	5.77	0.60	(	0.58	-	0.62	)
			40-49	313483	3980	309503	9.10	0.65	(	0.63	-	0.67	)
			50-59	437570	6594	430976	15.07	0.78	(	0.76	-	0.80	)
			60-69	418434	8319	410115	19.01	1.10	(	1.07	-	1.13	)
			70-79	286535	7844	278691	17.93	1.62	(	1.58	-	1.66	)
			80-89	139953	4928	135025	11.26	2.07	(	2.01	-	2.13	)
			≥ 90	19138	753	18385	1.72	2.20	(	2.04	-	2.37	)
		Dabigatran administration
			0-29	104	24	80	0.05	14.40	(	9.12	-	22.73	)
			30-39	76	8	68	0.02	5.65	(	2.72	-	11.76	)
			40-49	282	26	256	0.06	4.88	(	3.26	-	7.31	)
			50-59	1148	167	981	0.38	8.20	(	6.96	-	9.66	)
			60-69	3620	649	2971	1.48	10.62	(	9.75	-	11.57	)
			70-79	7059	1515	5544	3.46	13.55	(	12.79	-	14.35	)
			80-89	6393	1785	4608	4.08	19.34	(	18.30	-	20.44	)
			≥ 90	1045	367	678	0.84	26.18	(	23.05	-	29.74	)
	Warfarin
		Reference
			0-29	290568	4243	286325	9.70	0.74	(	0.72	-	0.76	)
			30-39	215267	2450	212817	5.60	0.57	(	0.55	-	0.59	)
			40-49	310402	3812	306590	8.71	0.61	(	0.59	-	0.63	)
			50-59	432272	6324	425948	14.45	0.72	(	0.70	-	0.74	)
			60-69	411028	7981	403047	18.24	1.03	(	1.00	-	1.06	)
			70-79	280036	8165	271871	18.66	1.70	(	1.66	-	1.74	)
			80-89	137147	5738	131409	13.11	2.47	(	2.40	-	2.54	)
			≥ 90	19092	1010	18082	2.31	2.94	(	2.76	-	3.13	)
		Warfarin administration
			0-29	1247	55	1192	0.13	2.22	(	1.69	-	2.91	)
			30-39	1701	83	1618	0.19	2.46	(	1.97	-	3.07	)
			40-49	3363	194	3169	0.44	2.95	(	2.55	-	3.41	)
			50-59	6446	437	6009	1.00	3.51	(	3.18	-	3.87	)
			60-69	11026	987	10039	2.26	4.80	(	4.49	-	5.13	)
			70-79	13558	1194	12364	2.73	4.74	(	4.46	-	5.03	)
			80-89	9199	975	8224	2.23	5.80	(	5.42	-	6.20	)
			≥ 90	1091	110	981	0.25	5.39	(	4.42	-	6.57	)