Table 4.
Overview of AEs in the Double‐Blind Reversal Phase (Safety Population)
| AEs | Patients With Event, No. (%) | |
|---|---|---|
| AZL‐M (n=148) | Placebo (n=151) | |
| Deaths | 0 | 0 |
| Serious AE | 0 | 1 (0.7) |
| Any AE | 42 (28.4) | 38 (25.2) |
| AE leading to discontinuationa | 3 (2.0) | 2 (1.3) |
| AE (preferred term) in ≥2% of patients in either group | ||
| Headache | 5 (3.4) | 8 (5.3) |
| Urinary tract infection | 4 (2.7) | 2 (1.3) |
| Hypokalemia | 3 (2.0) | 3 (2.0) |
| Pain in extremity | 3 (2.0) | 1 (0.7) |
| Back pain | 3 (2.0) | 0 |
| Dizziness | 3 (2.0) | 3 (2.0) |
| Renal impairment | 3 (2.0) | 1 (0.7) |
| Chest pain | 0 | 3 (2.0) |
| Nasopharyngitis | 0 | 3 (2.0) |
Abbreviation: AZL‐M, azilsartan medoxomil. aAdverse events (AEs) leading to temporary drug interruption or permanent discontinuation.