Table 4.
Adverse events by treatment group
| Number (%) of patients reporting | |||
|---|---|---|---|
| Adverse Event | DCS (N=34) | Placebo (N=33) | p value |
| Any Adverse Event | 32 (94.1) | 28 (84.8) | 0.26 |
| Headache (including sinus headache) | 9 (26.5) | 7 (21.2) | 0.80 |
| Nasal congestion or Cold | 6 (17.6) | 8 (24.2) | 0.79 |
| Cough | 7 (20.6) | 7 (21.2 | 0.99 |
| Vomiting | 6 (17.6) | 2 (6.1) | 0.29 |
| Aggression | 2 (5.9) | 5 (15.2) | 0.45 |
| Increased motor activity | 1 (2.9) | 5 (15.2) | 0.22 |
| Interrupted sleep/ other sleep problems | 3 (8.8) | 5 (15.2) | 0.73 |
| Irritability (including agitation) | 16 (47.1) | 15 (45.5) | 0.99 |
| Restlessness/Agitation | 4 (11.8) | 3 (9.1) | 0.99 |
| Sadness | 5 (14.7) | 3 (9.1) | 0.73 |
| Sedation/Drowsiness | 2 (5.9) | 6 (18.2) | 0.29 |
| Not otherwise listed | 10 (29.4) | 12 (36.4) | 0.83 |
| Any Serious Adverse Event | 0 | 1 (3.0) | 0.99 |