Table 4.

Association of post-randomization orthostatic hypotension as a time-varying covariate with trial outcomes and serious adverse events by blood pressure goal assignment, N=8,792.

	Standard Blood Pressure Goal				Intensive Blood Pressure Goal				P-interaction
	Events	HR (95% CI)	P		Events	HR (95% CI)	P
Outcomes
Primary outcome	369	0.94 (0.62, 1.44)	0.79		280	1.04 (0.63, 1.72)	0.87		0.52
Secondary outcomes
Myocardial infarction	144	1.01 (0.51, 1.99)	0.98		102	0.87 (0.33, 2.26)	0.78		0.81
Acute coronary syndrome	44	0.35 (0.05, 2.73)	0.32		40	2.56 (1.04, 6.31)	0.04		0.03
Stroke	85	0.52 (0.18, 1.50)	0.23		71	1.18 (0.42, 3.32)	0.75		0.35
Heart failure	105	1.33 (0.66, 2.69)	0.42		82	0.34 (0.10, 1.23)	0.10		0.15
Death from cardiovascular causes	72	0.72 (0.25, 2.09)	0.55		50	0.53 (0.12, 2.40)	0.41		0.79
Death from any cause	201	1.40 (0.85, 2.29)	0.18		163	0.72 (0.35, 1.48)	0.37		0.19
Primary outcome or death	475	1.09 (0.76, 1.55)	0.65		381	1.01 (0.66, 1.56)	0.95		0.88
Serious Adverse Events
Hypotension	74	3.26 (1.56, 6.81)	0.002		146	1.35 (0.71, 2.59)	0.36		0.31
Syncope	103	1.57 (0.72, 3.43)	0.26		144	1.55 (0.82, 2.95)	0.18		0.87
Bradycardia	78	1.96 (0.92, 4.18)	0.08		98	1.85 (0.89, 3.86)	0.10		0.63
Electrolyte abnormality	125	0.99 (0.46, 2.10)	0.97		173	0.91 (0.46, 1.80)	0.79		0.92
Injurious Fall	305	1.17 (0.74, 1.84)	0.50		349	1.14 (0.73, 1.78)	0.56		0.72
Acute kidney injury or acute renal failure	118	1.77 (0.88, 3.55)	0.11		199	0.99 (0.51, 1.93)	0.97		0.19

Models were adjusted for baseline orthostatic hypotension and the following baseline characteristics: age, sex, race, treatment assignment, systolic blood pressure, diastolic blood pressure, body mass index, high density lipoprotein cholesterol, total cholesterol, statin use, chronic kidney disease, estimated glomerular filtration rate, subclinical or clinical cardiovascular disease, smoking status, or number of hypertensive medications

Stratified by research site.