TABLE 3.
Patients experiencing adverse events1.
| Variable | Avidekel (n = 37) | Placebo (n = 20) | P |
| Serious adverse events, n (%) | |||
| Hospitalization | 7 (19) | 4 (20) | 0.74 |
| Death | 2 (5) | 0 (0) | – |
| Adverse events, n (%) | |||
| Decreased memory | 12 (32) | 2 (10) | 0.06 |
| Hallucinations | 8 (22) | 1 (5) | 0.08 |
| Sleepiness | 18 (49) | 6 (30) | 0.17 |
| Dry mouth | 5 (14) | 5 (25) | 0.17 |
| Confusion and disorientation | 17 (46) | 6 (30) | 0.18 |
| Fear | 9 (24) | 3 (15) | 0.34 |
| Restlessness | 10 (27) | 7 (35) | 0.39 |
| Blurred vision | 4 (11) | 1 (5) | 0.41 |
| Dizziness | 6 (16) | 2 (10) | 0.47 |
| Weakness | 8 (22) | 5 (25) | 0.54 |
| Red/Irritated eyes | 2 (5) | 1 (5) | 0.61 |
| Increased heart rate | 3 (8) | 1 (5) | 0.65 |
| Psychoactive effects | 3 (8) | 1 (5) | 0.65 |
| Headaches | 3 (8) | 2 (10) | 0.66 |
| Slurred speech | 6 (16) | 3 (15) | 0.99 |
| Decreased concentration | 0 (0) | 1 (5) | – |
| Other | 21 (57) | 9 (45) | 0.29 |
| Patients experiencing any adverse event | 34 (91) | 18 (90) | 0.99 |
1The analysis was performed on an intention-to-treat population. In three patients, there were no visits after treatment initiation and side-effect reports were not available.