. 2017 Aug 23;31(1):97–107. doi: 10.1093/ajh/hpx138

Table 4.

Selected serious adverse events stratified by treatment group and by race/ethnicity

Outcome	Race/ethnicity	Intensive arm			Standard arm			Intensive vs. standard hazard ratio			Interaction P value
Outcome	Race/ethnicity	N	Events	% per Year	N	Events	% per Year	HR	Lower 95% CI	Upper 95% CI	Interaction P value
Any SAE^a	(Non-Hispanic) White	2,698	430	5.5	2,701	5.9	17.0	0.93	0.82	1.06	0.24
	(Non-Hispanic) Black	1,379	146	3.6	1,379	147	3.6	1.02	0.81	1.29
	Hispanic	503	42	2.7	481	29	1.9	1.40	0.87	2.24
Hypotension	(Non-Hispanic) White	2,698	38	0.4	2,701	27	0.3	1.40	0.86	2.30	0.28
	(Non-Hispanic) Black	1,379	11	0.3	1,379	11	0.3	1.03	0.45	2.38
	Hispanic	503	2	0.1	481	0	0.0	–	–	–
Syncope	(Non-Hispanic) White	2,698	39	0.5	2,701	31	0.4	1.24	0.77	1.99	0.94
	(Non-Hispanic) Black	1,379	9	0.2	1,379	7	0.2	1.32	0.49	3.56
	Hispanic	503	5	0.3	481	3	0.2	1.59	0.38	6.66
Bradycardia	(Non-Hispanic) White	2,698	32	0.4	2,701	29	0.3	1.10	0.66	1.81	0.30
	(Non-Hispanic) Black	1,379	4	0.1	1,379	8	0.2	0.51	0.15	1.70
	Hispanic	503	1	0.1	481	3	0.2	0.32	0.03	3.05
Electrolyte abnormality^b	(Non-Hispanic) White	2,698	48	0.6	2,701	37	0.4	1.29	0.84	1.98	0.11
	(Non-Hispanic) Black	1,379	16	0.4	1,379	13	0.3	1.27	0.61	2.64
	Hispanic	503	4	0.3	481	0	0.0	–	–	–
Injurious fall^c	(Non-Hispanic) White	2,698	93	1.1	2,701	115	1.4	0.80	0.61	1.05	0.11
	(Non-Hispanic) Black	1,379	26	0.6	1,379	21	0.4	1.28	0.72	2.27
	Hispanic	503	6	0.4	481	2	0.1	2.88	0.58	14.3
Acute kidney injury^d	(Non-Hispanic) White	2,698	66	0.8	2,701	49	0.6	1.34	0.93	1.94	0.46
	(Non-Hispanic) Black	1,379	43	1.0	1,379	23	0.5	1.95	1.17	3.23
	Hispanic	503	6	0.4	481	5	0.3	1.15	0.35	3.78

Abbreviation: CI, confidence interval, SAE, serious adverse event.

^aSAEs were defined as an adverse experience judged by an investigator to be life threatening and/or resulting in death, permanent disability, hospitalization, or prolongation of hospitalization, whether or not the event was thought to be related to the study intervention.

^bElectrolyte abnormality were adverse laboratory measures detected on routine or unscheduled tests; routine laboratory tests were performed at 1 month, then quarterly during the first year, then every 6 months.

^cAn injurious fall was defined as a fall that resulted in evaluation in an emergency department or that resulted in hospitalization.

^dAcute kidney injury or acute renal failure were based on a primary or secondary diagnosis listed in the hospital discharge summary and was believed by the safety officer to be 1 of the top 3 reasons for admission or continue.