Table III.
No. (%) of Patients Having Treatment‐Emergent Adverse Events (TEAEs) and Drug‐Related TEAEs (DR‐TEAEs)
| AML 5 + OM 40, mg/d (n=1679) | AML 10 + OM 40, mg/d (n=1124) | AML 10 + OM 40 + HCTZ 12.5, mg/d (n=736) | AML 10 + OM 40 + HCTZ 25, mg/d (n=440) | |
|---|---|---|---|---|
| Any TEAE, No. (%) | 622 (37.0) | 455 (40.5) | 312 (42.4) | 248 (56.4) |
| Any discontinuations due to TEAE, No. (%) | 28 (1.7) | 17 (1.5) | 11 (1.5) | 11 (2.5) |
| Any DR‐TEAE, No. (%) | 221 (13.2) | 195 (17.3) | 124 (16.8) | 89 (20.2) |
| Serious DR‐TEAE, No. (%) | 1 (0.1) | 0 | 0 | 0 |
| Discontinuations due to DR‐TEAE, No. (%) | 16 (1.0) | 11 (1.0) | 3 (0.4) | 4 (0.9) |
| Specific DR‐TEAEs | ||||
| Edema,a No. (%) | 118 (7.0) | 125 (11.1) | 67 (9.1) | 47 (10.7) |
| Dizziness, No. (%) | 24 (1.4) | 19 (1.7) | 13 (1.8) | 9 (2.0) |
| Headache, No. (%) | 15 (0.9) | 10 (0.9) | 5 (0.7) | 5 (1.1) |
| Hypotension,b No. (%) | 11 (0.7) | 7 (0.6) | 10 (1.4) | 3 (0.7) |
| Cough, No. (%) | 2 (0.1) | 2 (0.2) | 1 (0.1) | 2 (0.5) |
Abbreviations: AML, amlodipine; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil. aIncludes preferred terms of edema, edema peripheral, and pitting edema. bIncludes preferred terms of hypotension, orthostatic hypotension, blood pressure decreased, and diastolic blood pressure decreased.