TABLE 3.
Summary of overall safety
| Placebo (n = 24) | Quarter‐dose (n = 25) | Third‐dose (n = 25) | Half‐dose (n = 25) | Amlodipine 5 mg (n = 26) | Amlodipine 10 mg (n = 25) | Telmisartan 80 mg (n = 24) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n (%) | No. of events | n (%) | No. of events | n (%) | No. of events | n (%) | No. of events | n (%) | No. of events | n (%) | No. of events | n (%) | No. of events | |
| Adverse events | 2 (8.33) | 2 | 1 (4.00) | 1 | 3 (13.04) | 5 | 3 (12.50) | 3 | 2 (7.69) | 4 | 3 (12.00) | 4 | 4 (16.67) | 8 |
| Adverse drug reactions | 0 | 0 | 1 (4.00) | 1 | 2 (8.70) | 3 | 2 (8.33) | 2 | 2 (7.69) | 2 | 1 (4.00) | 2 | 2 (8.33) | 2 |
| Severity | ||||||||||||||
| Mild | 0 | 0 | 0 | 0 | 2 (8.70) | 3 | 2 (8.33) | 2 | 2 (7.69) | 2 | 1 (4.00) | 2 | 2 (8.33) | 2 |
| Moderate | 0 | 0 | 1 (4.00) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Specific term | ||||||||||||||
| Chest pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (7.69) | 2 | 0 | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.00) | 1 | 0 | 0 |
| Peripheral swelling | 0 | 0 | 0 | 0 | 1 (4.35) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chronic gastritis | 0 | 0 | 0 | 0 | 1 (4.35) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dyspepsia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.17) | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Eye swelling | 0 | 0 | 0 | 0 | 1 (4.35) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blood potassium increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.17) | 1 |
| Headache | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.17) | 1 |
| Insomnia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.00) | 1 | 0 | 0 |
| Pruritus | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.17) | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Flushing | 0 | 0 | 1 (4.00) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious adverse events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.85) | 1 | 0 | 0 | 2 (8.33) | 2 |
| Serious adverse drug reactions | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The percentage was calculated using the number of subjects for each parameter in each group as a denominator. Multiple adverse events may be collected from one subject. MedDRA version 24.0.