Table 2.

Serious Adverse Events.^*

Event	Lisinopril–Telmisartan (N = 244)	Lisinopril–Placebo (N = 242)
Mean duration of follow-up — yr	5.2	5.2
Death — no. of participants (%)†	4 (1.6)	5 (2.1)
Cardiac disorder
No. of events	12	18
No. of participants (%)	11 (4.5)	13 (5.4)
Coronary artery disease
No. of events	3	9
No. of participants (%)	3 (1.2)	9 (3.7)
Arrhythmia
No. of events	5	6
No. of participants (%)	4 (1.6)	3 (1.2)
Other
No. of events	4	3
No. of participants (%)	4 (1.6)	3 (1.2)
Gastrointestinal disorder
No. of events	18	33
No. of participants (%)	15 (6.1)	25 (10.3)
Nervous system disorder
No. of events	9	10
No. of participants (%)	8 (3.3)	9 (3.7)
Cerebrovascular event
No. of events	4	3
No. of participants (%)	4 (1.6)	3 (1.2)
Headache
No. of events	2	2
No. of participants (%)	2 (0.8)	2 (0.8)
Other
No. of events	3	5
No. of participants (%)	3 (1.2)	4 (1.7)
Renal or urinary system disorder
No. of events	14	34
No. of participants (%)	14 (5.7)	19 (7.9)
Renal hemorrhage or hematuria
No. of events	5	2
No. of participants (%)	5 (2.0)	2 (0.8)
Nephrolithiasis or renal colic
No. of events	1	12
No. of participants (%)	1 (0.4)	4 (1.7)
Acute kidney injury
No. of events	3	5
No. of participants (%)	3 (1.2)	5 (2.1)
Other
No. of events	5	15
No. of participants (%)	5 (2.0)	12 (5.0)

^*All serious adverse events were classified with the use of the Common Terminology Criteria for Adverse Events, version 4.0. Patients may have had more than one event in an overall category but were counted only once in the overall-category total.

^†Causes of death in the lisinopril–telmisartan group were glioblastoma multiforme, sudden death, respiratory failure, and renal failure (in one patient each). Causes of death in the lisinopril–placebo group were metastatic melanoma, cerebral hemorrhage, ruptured aneurysm, pulmonary embolism, and renal failure (in one patient each).