Table 2.
Overview of AEs in the Open‐Label Phase (Safety Population)
| AEs | Patients, No. (%) | ||
|---|---|---|---|
| Total Cohort (N=418) | AZL‐Ma (n=179) | AZL‐M+CLDb (n=239) | |
| Death | 0 | 0 | 0 |
| Serious AE | 8 (1.9) | 5 (2.8) | 3 (1.3) |
| Any AE | 226 (54.1) | 96 (53.6) | 130 (54.4) |
| AE leading to discontinuationc | 29 (6.9) | 14 (7.8) | 15 (6.3) |
| AE (preferred term) in ≥3% of all patients | |||
| Dizziness | 37 (8.9) | 16 (8.9) | 21 (8.8) |
| Headache | 30 (7.2) | 13 (7.3) | 17 (7.1) |
| Fatigue | 16 (3.8) | 6 (3.4) | 10 (4.2) |
| Urinary tract infection | 16 (3.8) | 6 (3.4) | 10 (4.2) |
| Hypotension | 15 (3.6) | 4 (2.2) | 11 (4.6) |
Abbreviation: AZL‐M, azilsartan medoxomil. Note that the individual columns in italics do not represent randomized groups and are part of a single cohort. aPatients who did not require additional treatment with chlorthalidone (CLD) during the open‐label phase. bPatients who required additional treatment with CLD after week 8 during the open‐label phase. cAdverse events (AEs) leading to temporary drug interruption or permanent discontinuation.