Table 5. Participants with New Onset or Worsening Compared to Baseline of Signs or Symptoms on Side Effect Checklist (SEC), by Treatment Group.
| Galantamine | Oxytocin | Placebo | P-value* | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SEC Item | N | n | % | N | n | % | N | n | % | |
| Abdominal Pain | 20 | 1 | 5.0 | 16 | 2 | 12.5 | 20 | 2 | 10.0 | 0.85 |
| Anorexia | 20 | 2 | 10.0 | 16 | 3 | 18.8 | 20 | 3 | 15.0 | 0.89 |
| Bruising Easily | 20 | 2 | 10.0 | 16 | 0 | 0.0 | 20 | 0 | 0.0 | 0.32 |
| Constipation | 20 | 0 | 0.0 | 16 | 0 | 0.0 | 20 | 0 | 0.0 | 1.00 |
| Diarrhea | 20 | 6 | 30.0 | 16 | 3 | 18.8 | 20 | 1 | 5.0 | 0.13 |
| Dizziness | 20 | 6 | 30.0 | 16 | 3 | 18.8 | 20 | 1 | 5.0 | 0.13 |
| Dry Eye | 18 | 0 | 0.0 | 15 | 1 | 6.7 | 17 | 1 | 5.9 | 0.53 |
| Dry Mouth | 20 | 1 | 5.0 | 16 | 3 | 18.8 | 20 | 2 | 10.0 | 0.48 |
| Enuresis | 20 | 1 | 5.0 | 16 | 4 | 25.0 | 20 | 0 | 0.0 | 0.03 |
| Excessive Tearing | 18 | 1 | 5.6 | 15 | 1 | 6.7 | 17 | 1 | 5.9 | 1.00 |
| Fever | 20 | 1 | 5.0 | 16 | 0 | 0.0 | 20 | 0 | 0.0 | 1.00 |
| Headache | 20 | 5 | 25.0 | 16 | 2 | 12.5 | 20 | 3 | 15.0 | 0.68 |
| Hyperhydrosis | 18 | 0 | 0.0 | 15 | 0 | 0.0 | 17 | 0 | 0.0 | 1.00 |
| Hypersalivation | 20 | 3 | 15.0 | 16 | 3 | 18.8 | 20 | 5 | 25.0 | 0.78 |
| Insomnia | 20 | 2 | 10.0 | 16 | 3 | 18.8 | 20 | 1 | 5.0 | 0.48 |
| Malaise | 20 | 0 | 0.0 | 16 | 3 | 18.8 | 20 | 2 | 10.0 | 0.18 |
| Mucosal Ulceration | 20 | 1 | 5.0 | 16 | 1 | 6.3 | 20 | 0 | 0.0 | 0.74 |
| Nasal Irritation | 18 | 3 | 16.7 | 15 | 5 | 33.3 | 17 | 4 | 23.5 | 0.60 |
| Nausea | 20 | 3 | 15.0 | 16 | 3 | 18.8 | 20 | 1 | 5.0 | 0.47 |
| Rash | 20 | 2 | 10.0 | 16 | 2 | 12.5 | 20 | 2 | 10.0 | 1.00 |
| Restlessness | 20 | 2 | 10.0 | 16 | 3 | 18.8 | 20 | 3 | 15.0 | 0.89 |
| Sedation | 20 | 3 | 15.0 | 16 | 2 | 12.5 | 20 | 2 | 10.0 | 1.00 |
| Sore Throat | 20 | 2 | 10.0 | 16 | 1 | 6.3 | 20 | 1 | 5.0 | 1.00 |
| Stiffness | 20 | 2 | 10.0 | 16 | 1 | 6.3 | 20 | 2 | 10.0 | 1.00 |
| Tinnitus | 20 | 0 | 0.0 | 16 | 0 | 0.0 | 19 | 2 | 10.5 | 0.20 |
| Tremor | 20 | 3 | 15.0 | 16 | 1 | 6.3 | 20 | 2 | 10.0 | 0.87 |
| Urticaria | 20 | 3 | 15.0 | 16 | 3 | 18.8 | 20 | 3 | 15.0 | 1.00 |
| Uterine Contractions | 6 | 0 | 0.0 | 2 | 0 | 0.0 | 3 | 0 | 0.0 | 1.00 |
| Vomiting | 20 | 1 | 5.0 | 16 | 2 | 12.5 | 20 | 2 | 10.0 | 0.85 |
| Weight Loss | 20 | 1 | 5.0 | 16 | 3 | 18.8 | 20 | 5 | 25.0 | 0.22 |
| Wheezing | 18 | 1 | 5.6 | 15 | 2 | 13.3 | 17 | 2 | 11.8 | 0.72 |
*
Fisher's exact test p-value for any difference among treatments