Table III.
Adverse Events With an Incidence ≥2% in Any Treatment Arm
| Telmisartan‐HCTZ 80/25 mg (n=485) | Valsartan‐HCTZ 160/25 mg (n=498) | Placebo (N=126) | ||||
|---|---|---|---|---|---|---|
| Adverse Event* | n | % | n | % | n | % |
| Diarrhea | 9 | 1.9 | 12 | 2.4 | 5 | 4.0 |
| Dry mouth | 3 | 0.6 | 3 | 0.6 | 4 | 3.2 |
| Nausea | 11 | 2.3 | 9 | 1.8 | 1 | 0.8 |
| Fatigue | 10 | 2.1 | 7 | 1.4 | 3 | 2.4 |
| Peripheral edema | 4 | 0.8 | 2 | 0.4 | 4 | 3.2 |
| Sinusitis | 5 | 1.0 | 17 | 3.4 | 3 | 2.4 |
| Upper respiratory infection | 9 | 1.9 | 13 | 2.6 | 6 | 4.8 |
| Back pain | 14 | 2.9 | 8 | 1.6 | 1 | 0.8 |
| Muscle spasm | 2 | 0.4 | 3 | 0.6 | 3 | 2.4 |
| Dizziness | 22 | 4.5 | 13 | 2.6 | 4 | 3.2 |
| Headache | 18 | 3.7 | 31 | 6.2 | 15 | 11.9 |
| Cough | 5 | 1.0 | 9 | 1.8 | 3 | 2.4 |
| Increased blood pressure | 2 | 0.4 | 3 | 0.6 | 4 | 3.2 |
| HCTZ indicates hydrochlorothiazide. * Medical Dictionary for Regulatory Activities (MedDRA) 14 preferred term. | ||||||