Table II.
Summary of AEs
| AE, No. (%) | AML/OM 5/20 mg (N=999) | AML/OM 5/40 mg (N=892) | AML/OM 10/40 mg (N=795) | AML/OM 10/40+HCTZ 12.5 mg (N=699) | AML/OM 10/40+HCTZ 25 mg (N=496) | Totala (N=999) |
|---|---|---|---|---|---|---|
| Patients with any TEAE | 214 (21.4) | 158 (17.7) | 188 (23.6) | 180 (25.8) | 99 (20.0) | 529 (53.0) |
| Patients with any drug‐related TEAE | 75 (7.5) | 39 (4.4) | 70 (8.8) | 74 (10.6) | 47 (9.5) | 255 (25.5) |
| Patients with any serious TEAE | 2 (0.2) | 3 (0.3) | 3 (0.4) | 3 (0.4) | 1 (0.2) | 12 (1.2)b |
| Patients with any drug‐related serious TEAE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0)c | 0 (0.0) |
| Drug‐related TEAEs: >1% of patients | ||||||
| Peripheral edema | 13 (1.3) | 8 (0.9) | 35 (4.4) | 7 (1.0) | 4 (0.8) | 65 (6.5) |
| Nausea | 6 (0.6) | 4 (0.4) | 1 (0.1) | 3 (0.4) | 1 (0.2) | 14 (1.4) |
| Fatigue | 9 (0.9) | 3 (0.3) | 2 (0.3) | 4 (0.6) | 2 (0.4) | 20 (2.0) |
| Dizziness | 20 (2.0) | 10 (1.1) | 11 (1.4) | 26 (3.7) | 13 (2.6) | 76 (7.6) |
| Dizziness, postural | 1 (0.1) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) | 2 (0.2) |
| Headache | 8 (0.8) | 5 (0.6) | 3 (0.4) | 3 (0.4) | 1 (0.2) | 20 (2.0) |
| Blood uric acid increase | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.3) | 6 (1.2) | 8 (0.8) |
| Hypotension | 3 (0.3) | 6 (0.7) | 5 (0.6) | 4 (0.6) | 5 (1.0) | 23 (2.3) |
| Orthostatic hypotensiond | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 1 (0.2) | 2 (0.2) |
Abbreviations: AML, amlodipine; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; SAE, serious adverse event (AE); TEAE, treatment‐emergent AE. aThe total number of patients with an AE may not match the sum of the individual titration steps because a single patient could experience the same event at ≥1 titration step. bOne additional SAE (unstable angina and non–ST‐elevation myocardial infarction) occurred in 1 patient with a history of type 2 diabetes and hypertension while taking AML/OM 10/40+HCTZ 25 mg. This SAE, which was not considered by the investigator to be related to study drug, was not reported until 2 months after database lock and was not recorded in the clinical database. cOne serious TEAE (abdominal pain) was considered to be possibly related to HCTZ 25 mg as recorded in the ARISg risk management database (Aris Global LLC, Stamford, CT) by the investigator. This event was not recorded by the investigators as drug‐related on the clinical report form. dDrug‐related TEAE occurred at an incidence of <1%; however, it was considered to be a drug‐related TEAE of interest.