Table 2.
Summary of AEs
| AE, No. (%) | AML/OM 5/20 mg | AML/OM 5/40 mg | AML/OM 10/40 mg | AML/OM 10/40 mg +HCTZ 12.5 mg | AML/OM 10/40 mg +HCTZ 25 mg |
|---|---|---|---|---|---|
| Blacks, No. | 234 | 219 | 199 | 183 | 136 |
| Patients with any TEAE a | 45 (19.2) | 41 (18.7) | 47 (23.6) | 51 (27.9) | 19 (14.0) |
| Patients with any drug‐related TEAE | 14 (6.0) | 8 (3.7) | 13 (6.5) | 16 (8.7) | 7 (5.1) |
| Patients with any serious TEAE | 0 (0.0) | 1 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Individual drug‐related TEAEs in >1% of patients | |||||
| Dizziness | 3 (1.3) | 1 (0.5) | 0 (0.0) | 6 (3.3) | 1 (0.7) |
| Peripheral edema | 1 (0.4) | 2 (0.9) | 5 (2.5) | 1 (0.5) | 0 (0.0) |
| Blood creatinine increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) | 2 (1.5) |
| Headache | 3 (1.3) | 2 (0.9) | 2 (1.0) | 2 (1.1) | 0 (0.0) |
| Edema | 0 (0.0) | 0 (0.0) | 2 (1.0) | 0 (0.0) | 0 (0.0) |
| Non‐blacks, No. | 765 | 673 | 596 | 516 | 360 |
| Patients with any TEAE a | 169 (22.1) | 117 (17.4) | 141 (23.7) | 129 (25.0) | 80 (22.2) |
| Patients with any drug‐related TEAE | 61 (8.0) | 31 (4.6) | 57 (9.6) | 58 (11.2) | 40 (11.1) |
| Patients with any serious TEAE | 2 (0.3) | 2 (0.3) | 3 (0.5) | 3 (0.6) | 1 (0.3) |
| Individual drug‐related TEAEs in >1% of patients | |||||
| Peripheral edema | 12 (1.6) | 6 (0.9) | 30 (5.0) | 6 (1.2) | 4 (1.1) |
| Dizziness | 17 (2.2) | 9 (1.3) | 11 (1.8) | 20 (3.9) | 12 (3.3) |
| Blood uric acid increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.2) | 6 (1.7) |
| Fatigue | 9 (1.2) | 3 (0.4) | 2 (0.3) | 4 (0.8) | 2 (0.6) |
| Hypotension | 3 (0.4) | 5 (0.7) | 4 (0.7) | 4 (0.8) | 4 (1.1) |
Abbreviations: AE, adverse event; AML, amlodipine; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; SAE, serious AE. aTreatment‐emergent AE (TEAE) is any AE that either first occurred on/after the first active dose date, or occurred before the first active dose date, then occurred again during active treatment with worsened severity, and occurred no later than 14 days after the last active dose.