Table 4. Treatment-emerging adverse events.
| Adverse events | Participants (N = 48) (%) | Linked to interventiona (N = 48) (%) |
Persistentb and/or recurrent (N = 48) (%) |
|---|---|---|---|
| Dry mouth | 7 (14.6) | 2 (4.2) | 4 (8.3) |
| Drowsiness | 9 (18.8) | 1 (2.1) | 5 (10.4) |
| Insomnia | 11 (22.9) | 7 (14.6) | 10 (20.8) |
| Blurred vision | 3 (6.3) | 0 (0) | 0 (0) |
| Headache | 13 (27.1) | 3 (6.3) | 9 (18.8) |
| Constipation | 3 (6.3) | 2 (4.2) | 0 (0) |
| Diarrhea | 14 (29.2) | 1 (2.1) | 3 (6.3) |
| Increased appetite | 17 (35.4) | 12 (25) | 14 (29.2) |
| Decreased appetite | 11 (22.9) | 4 (8.3) | 5 (10.4) |
| Nausea and vomiting | 20 (41.7) | 4 (8.3) | 9 (18.8) |
| Problems with urination | 3 (6.3) | 0 (0) | 2 (4.2) |
| Palpitations | 2 (4.2) | 1 (2.1) | 1 (2.1) |
| Feeling light-headed on standing | 6 (12.5) | 2 (4.2) | 2 (4.2) |
| Feeling like the room is spinning total | 11 (22.9) | 1 (2.1) | 1 (2.1) |
| Sweating | 7 (14.6) | 1 (2.1) | 5 (10.4) |
| Increased body temperature | 8 (16.7) | 2 (4.2) | 3 (6.3) |
| Tremor | 0 (0) | 0 (0) | 0 (0) |
| Disorientation | 1 (2.1) | 0 (0) | 0 (0) |
| Yawning | 11 (22.9) | 1 (2.1) | 3 (6.3) |
| Weight gain | 8 (16.7) | 4 (8.3) | 6 (12.5) |
| Eczema | 1 (2.1) | 2 (4.2) | 3 (6.3) |
Note.
aBased on parent-report and clinical judgement.
bPersistent = present for at least four weeks.