TABLE 4.
Overall summary of TEAEs
| Tel/Aml 80/5 mg + Ros 20 mg (N = 67) | Tel/Aml 80/5 mg (N = 67) | Tel 80 mg + Ros 20 mg (N = 65) | |
|---|---|---|---|
| Subjects with TEAEs | 12 (17.91) | 10 (14.93) | 8 (12.31) |
| Subjects with ADRs | 5 (7.46) | 6 (8.96) | 6 (9.23) |
| Dizziness | 2 (2.99) | 1 (1.49) | 0 |
| Headache | 0 | 0 | 2 (3.08) |
| Essential tremor | 0 | 0 | 1 (1.54) |
| Asthenia | 0 | 1 (1.49) | 1 (1.54) |
| Chest pain | 0 | 0 | 1 (1.54) |
| Oedema peripheral | 1 (1.49) | 0 | 0 |
| Helicobacter gastritis | 0 | 1 (1.49) | 0 |
| Upper respiratory tract infection | 0 | 0 | 1 (1.54) |
| Viral upper respiratory tract infection | 0 | 0 | 1 (1.54) |
| Palpitations | 0 | 0 | 1 (1.54) |
| Tachycardia | 0 | 0 | 1 (1.54) |
| Abdominal pain | 1 (1.49) | 0 | 0 |
| Constipation | 0 | 1 (1.49) | 0 |
| Arthralgia | 1 (1.49) | 0 | 0 |
| Myalgia | 0 | 1 (1.49) | 0 |
| Alanine aminotransferase increased | 1 (1.49) | 0 | 0 |
| Aspartate aminotransferase increased | 1 (1.49) | 0 | 0 |
| Blood alkaline phosphatase increased | 1 (1.49) | 0 | 0 |
| Gamma‐glutamyl transferase increased | 1 (1.49) | 0 | 0 |
| Gout | 0 | 1 (1.49) | 0 |
| Orthostatic hypotension | 0 | 0 | 1 (1.54) |
| Subjects with SAEs | 1 (1.49) | 0 | 1 (1.54) |
| Subjects with Serious ADRs | 0 | 0 | 0 |
| Subjects with TEAEs Leading to Discontinuation | 0 | 0 | 0 |
| Subjects with TEAEs Leading to Death | 0 | 0 | 0 |
| Subjects with ADRs Leading to Discontinuation | 0 | 0 | 0 |
| Subjects with ADRs Leading to Death | 0 | 0 | 0 |
Abbreviations: ADR, Adverse Drug Reaction; Aml, Amlodipine; Ros, Rosuvastatin; SAE, Serious Adverse Event; TEAE, Treatment Emergent Adverse Events; Tel, Telmisartan.