Table 3.
Treatment‐Emergent Serious AEs (Safety Population)
| No. of Patients (%) | ||
|---|---|---|
| System Organ Classa Preferred Term | AZL‐M/CLD (n=418) | OLM/HCTZ (n=419) |
| Any serious AE | 24 (5.7) | 26 (6.2) |
| Related | 2 (0.4) | 5 (1.2) |
| Cardiac disorders | 3 (0.7) | 5 (1.2) |
| Angina pectoris | 0 | 2 (0.5) |
| Atrial fibrillation | 1 (0.2) | 1 (0.2) |
| Cardiac arrest | 1 (0.2) | 0 |
| Cardiogenic shock | 1 (0.2) | 0 |
| Coronary artery disease | 0 | 1 (0.2) |
| Mitral valve incompetence | 1 (0.2) | 0 |
| Myocardial infarction | 0 | 1 (0.2) |
| Renal and urinary disorders | 0 | 1 (0.2) |
| Renal failure acute | 0 | 1 (0.2) |
| Vascular disorders | 1 (0.2) | 1 (0.2) |
| Arteriosclerosis | 0 | 1 (0.2) |
| Orthostatic hypotension | 1 (0.2) | 0 |
| Nervous system disorders | 3 (0.7) | 2 (0.5) |
| Syncope | 2 (0.5) | 0 |
| Loss of consciousness | 1 (0.2) | 0 |
| Presyncope | 0 | 1 (0.2) |
| Radicular syndrome | 1 (0.2) | 0 |
| Transient ischemic attack | 0 | 1 (0.2) |
Abbreviations: AE, adverse event; AZL‐M/CLD, azilsartan medoxomil/chlorthalidone; OLM/HCTZ, olmesartan medoxomil/hydrochlorothiazide.
a
Selected system organ classes only.