Table 3.
Adverse Events Occurring in at least 5% of any Treatment Group
| Adverse Event Categorya count (%) | Placebo (n=41) | 0.1 mg (n=41) | 0.5 mg (n=41) | Total (N=123) |
|---|---|---|---|---|
| Constipation | 1 (2.4) | 3 (7.3) | 0 (0.0) | 4 |
| Dry Mouth | 0 (0.0) | 3 (7.3) | 7 (17.1) | 10 |
| Fall | 1 (2.4) | 2 (4.9) | 3 (7.3) | 6 |
| Fatigue | 3 (7.3) | 3 (7.3) | 7 (17.1) | 13 |
| Gastroenteritis | 4 (9.8) | 0 (0.0) | 0 (0.0) | 4 |
| Joint Pain | 1 (2.4) | 1 (2.4) | 4 (9.8) | 6 |
| Lightheadedness | 4 (9.8) | 0 (0.0) | 4 (9.8) | 8 |
| Low Back Pain | 3 (7.3) | 0 (0.0) | 0 (0.0) | 3 |
| Sedation | 1 (2.4) | 3 (7.3) | 1 (2.4) | 5 |
| Upper Respiratory Infection | 9 (22.0) | 4 (9.8) | 3 (7.3) | 16 |
| Urinary Tract Infection | 3 (7.3) | 1 (2.4) | 1 (2.4) | 5 |
a
Fisher’s Exact Test: Dry Mouth (p = 0.02) & Gastroenteritis (p = 0.03). No Fisher’s Exact Test has an associated p < 0.05 after a False Discovery Rate correction for multiplicity.