Table 3.

Frequent adverse events (AEs) ≥ 1% (safety population) in either treatment group

Event	Aml/Val HCTZ N = 136	Aml HCTZ N = 208
AEs; n (%)	46 (33.8)	69 (33.2)
Edema peripheral	19 (14.0)	37 (17.8)
Nasopharyngitis	4 (2.9)	2 (1.0)
Headache	2 (1.5)	5 (2.4)
Dizziness	2 (1.5)	1 (0.5)
Syncope	2 (1.5)	0 (0.0)
Cough	1 (0.7)	4 (1.9)
Diarrhea	1 (0.7)	3 (1.4)
Viral infection	1 (0.7)	2 (1.0)
Paresthesia	0 (0.0)	2 (1.0)
Joint swelling	1 (0.7)	2 (1.0)
Dyspepsia	0 (0.0)	3 (1.4)
Flushing	0 (0.0)	3 (1.4)
Upper respiratory tract infection	0 (0.0)	2 (1.0)
Urinary tract infection	0 (0.0)	3 (1.4)
Hypokalemia	0 (0.0)	2 (1.0)
Arthralgia	0 (0.0)	2 (1.0)
Neck pain	0 (0.0)	2 (1.0)

Abbreviations: Aml/Val+HCTZ, amlodipine/valsartan+hydrochlorothiazide; Aml+HCTZ, amlodipine+hydrocholorothiazide.