Adverse events are reported as counts and percentages. Fisher’s exact test was used to test for differences in adverse events between the AVP and placebo treatment conditions. No significant effects were discerned. DOTES, Dosage Record Treatment Emergent Symptom Scale; OAS, Overt Aggression Scale; HEENT, head, ears, eyes, nose, and throat.
| Adverse event | AVP (n = 17) | Placebo (n = 13) |
| General | ||
| Fever | 2 (12%) | 1 (8%) |
| Cough | 1 (6%) | 0 (0%) |
| Body ache | 1 (6%) | 0 (0%) |
| Neurological/ psychiatric | ||
| Excitement/agitation | 4 (24%) | 1 (8%) |
| Insomnia | 4 (24%) | 1 (8%) |
| Increased motor activity | 4 (24%) | 0 (0%) |
| Depressive affect | 2 (12%) | 1 (8%) |
| Headache | 2 (12%) | 0 (0%) |
| Drowsiness | 1 (6%) | 3 (23%) |
| Decreased motor activity | 1 (6%) | 2 (15%) |
| Aggression | 1 (6%) | 1 (8%) |
| Akathisia | 1 (6%) | 0 (0%) |
| Head banging | 1 (6%) | 0 (0%) |
| Dizziness | 0 (0%) | 1 (8%) |
| Lethargy/tiredness | 0 (0%) | 1 (8%) |
| HEENT | ||
| Nasal congestion | 3 (18%) | 4 (31%) |
| Dry mouth | 1 (6%) | 3 (23%) |
| Blurred vision | 1 (6%) | 1 (8%) |
| Ear infection | 0 (0%) | 1 (8%) |
| Runny nose | 0 (0%) | 1 (8%) |
| Sore throat | 0 (0%) | 1 (8%) |
| Cold sore | 0 (0%) | 1 (8%) |
| Gastrointestinal | ||
| Decreased appetite | 4 (24%) | 5 (38%) |
| Nausea/vomiting | 2 (12%) | 2 (15%) |
| Constipation | 1 (6%) | 0 (0%) |
| Diarrhea | 0 (0%) | 1 (8%) |
| Renal | ||
| Increased urination | 1 (6%) | 1 (8%) |
| Bed-wetting | 1 (6%) | 0 (0%) |
| Dermatological | ||
| Skin rash | 1 (6%) | 1 (8%) |
| Bug bite | 1 (6%) | 0 (0%) |
| Skin burn | 0 (0%) | 1 (8%) |