Table IV.
Study Participants With Adverse Events by Onset Dosing Regimen
| OM 40/AML 5/HCTZ 12.5 mg (n=2112) | OM 40/AML 5/HCTZ 25 mg (n=627) | OM 40/AML 10/HCTZ 12.5 mg (n=652) | OM 40/AML 10/HCTZ 25 mg (n=790) | |
|---|---|---|---|---|
| All AEs | 989 (46.8) | 228 (36.4) | 244 (37.4) | 467 (59.1) |
| Mild | 531 (25.1) | 121 (19.3) | 120 (18.4) | 231 (29.2) |
| Moderate | 380 (18.0) | 86 (13.7) | 99 (15.2) | 189 (23.9) |
| Severe | 78 (3.7) | 21 (3.3) | 25 (3.8) | 47 (5.9) |
| Drug‐related AEsa | 311 (14.7) | 73 (11.6) | 69 (10.6) | 156 (19.7) |
| Serious AEs (SAEs) | ||||
| All SAEs | 40 (1.9) | 11 (1.8) | 17 (2.6) | 38 (4.8) |
| Drug‐related SAEs | 3 (0.1) | 2 (0.3) | 0 | 0 |
| Deaths | 1 (0.0) | 0 | 1 (0.2) | 1 (0.1) |
| Discontinuationsb | ||||
| All AEs | 74 (3.5) | 10 (1.6) | 12 (1.8) | 31 (3.9) |
| AEs starting in the open‐label treatment period | 67 (3.2) | 10 (1.6) | 11 (1.7) | 28 (3.5) |
| Drug‐related AEs starting in the open‐label treatment period | 45 (2.1) | 7 (1.1) | 7 (1.1) | 13 (1.6) |
| AEs occurring in ≥2% on any dosing regimen | ||||
| Dizziness | 91 (4.3) | 22 (3.5) | 22 (3.4) | 38 (4.8) |
| Headache | 47 (2.2) | 16 (2.6) | 17 (2.6) | 26 (3.3) |
| Peripheral edema | 42 (2.0) | 8 (1.3) | 26 (4.0) | 48 (6.1) |
| Cough | 44 (2.1) | 16 (2.6) | 8 (1.2) | 18 (2.3) |
| Upper respiratory tract infection | 72 (3.4) | 11 (1.8) | 16 (2.5) | 33 (4.2) |
| Nasopharyngitis | 55 (2.6) | 15 (2.4) | 14 (2.1) | 31 (3.9) |
| Urinary tract infection | 59 (2.8) | 15 (2.4) | 7 (1.1) | 23 (2.9) |
| Back pain | 31 (1.5) | 8 (1.3) | 15 (2.3) | 16 (2.0) |
| Arthralgia | 27 (1.3) | 7 (1.1) | 8 (1.2) | 27 (3.4) |
| Muscle spasms | 22 (1.0) | 10 (1.6) | 6 (0.9) | 18 (2.3) |
Abbreviations: AE, adverse event; AML, amlodipine besylate; OM, olmesartan medoxomil; HCTZ, hydrochlorothiazide. aDrug‐related was defined as definitely, probably, or possibly related to randomized study medication. bTwo participants discontinued the study due to SAEs that were considered possibly related to study medication (one receiving OM 40/AML 5/HCTZ 12.5 mg had acute renal insufficiency and another receiving OM 40/AML 5/HCTZ 25 mg had syncope). Data are presented as number (percentage) of study participants.