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. Author manuscript; available in PMC: 2009 Jul 22.
Published in final edited form as: N Engl J Med. 2008 Aug 27;359(12):1225–1237. doi: 10.1056/NEJMoa0804593

Table 2.

Selected Adverse Events Leading to Discontinuation of a Study Drug.

Adverse Event Telmisartan
(N = 10,146)
Placebo
(N = 10,186)
P Value
no. (%)
Total 1450 (14.3) 1127 (11.1) <0.001
Hypotensive symptoms 393 (3.9) 186 (1.8) <0.001
Syncope 21 (0.2) 6 (0.1) 0.004
Uncontrolled hypertension 13 (0.1) 17 (0.2) 0.47
Headache 231 (2.3) 203 (2.0) 0.16
Diarrhea 69 (0.7) 45 (0.4) 0.02
Nausea 104 (1.0) 72 (0.7) 0.01
Vomiting 74 (0.7) 61 (0.6) 0.25
Angioedema 23 (0.2) 31 (0.3) 0.28
Renal impairment 28 (0.3) 18 (0.2) 0.14
Hyperkalemia 14 (0.1) 6 (0.1) 0.07
Atrial fibrillation 81 (0.8) 50 (0.5) 0.006
HHS Vulnerability Disclosure