Table 3. Parameters for Safety Assessment.
| All patient | Group A | Group B | |
|---|---|---|---|
| Hypersensitivity (n) | - | - | - |
| Hypertensive Event (n) | 12 | 8 | 4 |
| Cardiac Arrhythmia (n) | 2 | - | 2 |
| Prolonged QT Interval (n) | - | - | - |
| Nasopharyngitis (n) | 1 | 1 | - |
| Headache (n) | 3 | 3 | - |
| Sinusitis (n) | 1 | 1 | - |
| Backpain (n) | 3 | 2 | 1 |
| Arthralgia (n) | 2 | - | 2 |
| Diarrhea (n) | 1 | - | 1 |
| Constipation (n) | 2 | - | 2 |
| Dry Mouth (n) | 11 | - | 11 |
| UTI (n) | 8 | 3 | 5 |
| AUR (n) | 1 | - | 1 |
| Syncope (n) | 1 | - | 1 |
| Nephrotoxicity (n) | 3 | 2 | 1 |
| Hepatotoxicity (n) | 2 | - | 2 |
| Cognitive Impairment (n) | - | - | - |
| Side Effects in Total (n) | 53 | 20 | 33 |
UTI = Urinary Tract Infection; AUR = Acute Urinary Retention