Table 2.
Safety observations during the double-blind treatment period
| Adverse event | OLM/AML 40/10 mg (n = 244) | PER/AML 8/10 mg (n = 241) | Total (n = 485) |
|---|---|---|---|
| ≥1 TEAE | 125 (51.2) | 114 (47.3) | 239 (49.3) |
| ≥1 drug-related TEAE | 61 (25.0) | 62 (25.7) | 123 (25.4) |
| ≥1 serious TEAE | 4 (1.6) | 4 (1.7) | 8 (1.6) |
| ≥1 serious drug-related TEAE | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| ≥1 severe TEAE | 6 (2.5) | 5 (2.1) | 11 (2.3) |
| Deaths | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinued due to TEAE | 18 (7.4) | 19 (7.9) | 37 (7.6) |
| Discontinued due to drug-related TEAE | 14 (5.7) | 18 (7.5) | 32 (6.6) |
| Patients with ≥1 TEAE | |||
| Peripheral edema | 43 (17.8) | 88 (18.1) | 45 (18.4) |
| Nasopharyngitis | 11 (4.5) | 14 (5.8) | 25 (5.2) |
| Cough | 5 (2.0) | 16 (6.6) | 21 (4.3) |
| Hypotension | 6 (2.5) | 2 (0.8) | 8 (1.6) |
| Bronchitis | 5 (2.0) | 2 (0.8) | 7 (1.4) |
| Diarrhea | 2 (0.8) | 5 (2.1) | 7 (1.4) |
| Erectile dysfunction | 3 (1.2) | 4 (1.7) | 7 (1.4) |
| Headache | 5 (2.0) | 2 (0.8) | 7 (1.4) |
| Upper respiratory tract infection | 3 (1.2) | 4 (1.7) | 7 (1.4) |
Data are number of patients (%)
AML amlodipine, OLM olmesartan, PER perindopril, TEAE treatment-emergent adverse event