Table IV.

Drug‐Related,* Treatment‐Emergent Clinical Adverse vents and Laboratory Adverse Events Occurring in 2% or More of Subjects in Any Treatment Group (Safety Cohort)

Adverse Event, No. (%)†	OM 20 mg/d (N=170)	OM 40 mg/d (n=160)	OM/HCTZ 40/12.5 mg/d (n=157)	OM/HCTZ 40/25 mg/d (n=144)
Any clinical‡	7 (4.1)	6 (3.8)	10 (6.4)	9 (6.3)
Dizziness	1 (0.6)	1 (0.6)	6 (3.8)	7 (4.9)
Fatigue	0 (0)	0 (0)	1 (0.6)	3 (2.1)
Any laboratory	0 (0)	0 (0)	0 (0)	8 (5.6)
Serum creatinine >3.0 mg/dL	0 (0)	0 (0)	0 (0)	3 (2.1)
GGT >300 U/L	0 (0)	0 (0)	0 (0)	3 (2.1)
*Only events considered by the investigator as definitely, probably, or possibly related to study drug are included. †Adverse events listed are those that occurred at each titration step; numbers shown are not cumulative. ‡Clinical adverse events do not include laboratory adverse events. OM indicates olmesartan medoxomil; HCTZ, hydrochlorothiazide; and GGT, γ‐glutamyltransferase.