Table 2 Summary of TEAEs (safety analysis set)
Total N = 101 | ARB n = 48 | CCB n = 53 | |
|---|---|---|---|
Any TEAEs | 39 (38.6) | 20 (41.7) | 19 (35.8) |
Drug-related TEAEs | 17 (16.8) | 9 (18.8) | 8 (15.1) |
Serious TEAEs | 1 (1.0) | 1 (2.1)a | 0 |
Drug-related serious TEAEs | 0 | 0 | 0 |
Discontinued study treatment due to TEAEs | 3 (3.0) | 3 (6.3) | 0 |
Discontinued study treatment due to drug-related TEAEs | 3 (3.0) | 3 (6.3) | 0 |
Death | 0 | 0 | 0 |
TEAEs occurring in ≥2 patients | |||
Hyperkalemia | 11 (10.9) | 4 (8.3) | 7 (13.2) |
Blood potassium increased | 4 (4.0) | 3 (6.3) | 1 (1.9) |
Arthropod sting | 3 (3.0) | 1 (2.1) | 2 (3.8) |
Pyrexia | 3 (3.0) | 1 (2.1) | 2 (3.8) |
Dizziness | 2 (2.0) | 0 | 2 (3.8) |
Gastroenteritis | 2 (2.0) | 1 (2.1) | 1 (1.9) |
Myalgia | 2 (2.0) | 2 (4.2) | 0 |
Renal disorder | 2 (2.0) | 2 (4.2) | 0 |
Drug-related TEAEs occurring in ≥2 patients | |||
Hyperkalemia | 10 (9.9) | 4 (8.3) | 6 (11.3) |
Blood potassium increased | 3 (3.0) | 3 (6.3) | 0 |
Renal disorder | 2 (2.0) | 2 (4.2) | 0 |
