Table 2.

Safety outcomes with dabigatran etexilate versus warfarin in Latin American (n=956) and non-Latin American (n=17 157) patients

	Dabigatran 110 mg twice daily					Dabigatran 150 mg twice daily					Warfarin
	LA (n=320)	HR vs warfarin (95% CI)	Non-LA (n=5695)	HR vs warfarin (95% CI)	Interaction p value	LA (n=320)	HR vs warfarin (95% CI)	Non-LA (n=5756)	HR vs warfarin (95% CI)	Interaction p value	LA (n=316)	Non-LA (n=5706)
	Event number (%/year)		Event number (%/year)			Event number (%/year)		Event number (%/year)			Event number (%/year)	Event number (%/year)
Major bleeding	11	0.63	331	0.81	0.52	15	0.86	384	0.94	0.81	17	404
	(2.01)	(0.29 to 1.34)	(2.92)	(0.70 to 0.94)		(2.72)	(0.43 to 1.72)	(3.34)	(0.81 to 1.08)		(3.18)	(3.59)
Gastrointestinal major bleeding	4	0.65	130	1.09	0.43	13	2.12	174	1.45	0.45	6	119
	(0.73)	(0.18 to 2.29)	(1.15)	(0.85 to 1.40)		(2.36)	(0.81 to 5.58)	(1.52)	(1.15 to 1.83)		(1.12)	(1.06)
Life-threatening major bleeding	6	0.83	141	0.66	0.68	5	0.69	174	0.81	0.80	7	211
	(1.09)	(0.28 to 2.48)	(1.24)	(0.53 to 0.82)		(0.91)	(0.22 to 2.18)	(1.52)	(0.66 to 0.99)		(1.31)	(1.87)
Intracranial haemorrhage	1 (0.18)	0.19 (0.02 to 1.67)	26 (0.23)	0.30 (0.19 to 0.47)	0.70	0 (0.00)	­–	38 (0.33)	0.44 (0.30 to 0.64)	0.98	5 (0.93)	85 (0.75)
Minor bleeding	70	0.70	1496	0.79	0.47	76	0.77	1711	0.92	0.25	93	1838
	(12.8)	(0.52 to 0.96)	(13.2)	(0.74 to 0.85)		(13.8)	(0.57 to 1.04)	(14.9)	(0.86 to 0.98)		(17.4)	(16.3)
Total bleeding	75	0.68	1680	0.79	0.35	83	0.76	1911	0.91	0.23	102	2064
	(13.7)	(0.50 to 0.91)	(14.8)	(0.74 to 0.84)		(15.1)	(0.57 to 1.02)	(16.6)	(0.86 to 0.97)		(19.1)	(18.3)

P values for treatment-by-region interaction are calculated by using Cox regression model with the terms for treatment, region and treatment-by-region interaction. The outcomes of major and intracranial haemorrhages were adjudicated by two independent investigators who were unaware of the treatment assignments.

LA, Latin American.