Table 2

Risk of clinical outcome events stratified by age categories

		Dabigatran 110 mg (n=6015)		Dabigatran 150 mg (n=6076)		Warfarin (n=6022)		Dabigatran 110 mg versus warfarin			Dabigatran 150 mg versus warfarin
Clinical outcome	Age	Number of events	Event Rate (%/year)	Number of events	Event rate (%/year)	Number of events	Event rate (%/year)	HR (95% CI)	p value for interaction (age groups)*	p value for interaction (age continuous)	HR (95% CI)	p value for interaction (age groups)*	p value for interaction (age continuous)
Stroke/Non-CNS systemic embolism	<75, n=10 855	96	1.32	65	0.90	101	1.43	0.93 (0.70 to 1.22)	0.394	0.253	0.63 (0.46 to 0.86)	0.996	0.498
	75–79, n=4231	52	1.90	32	1.14	49	1.76	1.08 (0.73 to 1.60)			0.65 (0.42 to 1.01)
	80–84, n=2305	28	1.95	27	1.73	38	2.58	0.75 (0.46 to 1.23)			0.67 (0.41 to 1.10)
	≥85, n=722	7	1.61	10	2.15	14	3.09	0.52 (0.21 to 1.29)			0.70 (0.31 to 1.57)
Major bleeding	<75, n=10 855	138	1.89	153	2.12	215	3.04	0.62 (0.50 to 0.77)	0.006	<0.001	0.70 (0.57 to 0.86)	0.001	<0.001
	75–79, n=4231	106	3.87	120	4.28	116	4.16	0.93 (0.71 to 1.21)			1.04 (0.81 to 1.35)
	80–84, n=2305	72	5.01	92	5.91	63	4.28	1.18 (0.84 to 1.65)			1.41 (1.02 to 1.94)
	≥85, n=722	26	6.00	34	7.29	27	5.96	1.01 (0.59 to 1.73)			1.22 (0.74 to 2.02)
Intracranial major bleeding	<75, n=10 855	10	0.14	19	0.26	43	0.61	0.22 (0.11 to 0.45)	0.347	0.667	0.43 (0.25 to 0.74)	0.481	0.548
	75–79, n=4231	11	0.40	5	0.18	22	0.79	0.51 (0.25 to 1.04)			0.23 (0.09 to 0.60)
	80–84, n=2305	5	0.35	10	0.64	17	1.16	0.30 (0.11 to 0.82)			0.55 (0.25 to 1.21)
	≥85, n=722	1	0.23	5	1.07	8	1.77	0.13 (0.02 to 1.04)			0.61 (0.20 to 1.87)
Extracranial major bleeding	<75, n=10 855	128	1.76	137	1.90	173	2.44	0.72 (0.57 to 0.90)	0.004	<0.001	0.78 (0.62 to 0.97)	0.001	<0.001
	75–79, n=4231	96	3.51	115	4.11	95	3.41	1.03 (0.78 to 1.37)			1.22 (0.93 to 1.61)
	80–84, n=2305	68	4.73	82	5.27	47	3.20	1.50 (1.03 to 2.18)			1.68 (1.18 to 2.41)
	≥85, n=722	25	5.77	29	6.22	20	4.41	1.32 (0.73 to 2.38)			1.41 (0.80 to 2.49)
All-cause mortality	<75, n=10 855	206	2.83	192	2.66	245	3.46	0.82 (0.68 to 0.98)	0.088	0.026	0.77 (0.64 to 0.93)	0.068	0.014
	75–79, n=4231	105	3.84	103	3.68	124	4.45	0.86 (0.66 to 1.11)			0.82 (0.63 to 1.07)
	80–84, n=2305	87	6.05	100	6.42	82	5.57	1.09 (0.80 to 1.47)			1.16 (0.87 to 1.55)
	≥85, n=722	48	11.07	43	9.23	36	7.95	1.37 (0.89 to 2.11)			1.15 (0.74 to 1.79)

There were 10 855, 4231, 2305 and 722 patients in the age categories of<75, 75–79, 80–84 and≥85 years; respectively.
*p Value for interaction is from Wald’s test of interaction between age and treatment.
CNS, central nervous system.