Table 6.
Treatment emergent signs and symptoms (TESS) in study of effect of melatonin on sleep problems in children with neurodevelopmental disorders
| Event | Melatonin (n=70) | Placebo (n=76) | |||
|---|---|---|---|---|---|
| No (%) of children | Events | No (%) of children | Events | ||
| Prompted adverse events report (TESS) | |||||
| Coughing | 22 (31.4) | 36 | 28 (36.8) | 42 | |
| Mood swings | 16 (22.9) | 34 | 17 (22.4) | 25 | |
| Vomiting | 15 (21.4) | 29 | 18 (23.7) | 32 | |
| Increased excitability | 13 (18.6) | 23 | 16 (21.1) | 19 | |
| Rash | 11 (15.7) | 17 | 8 (10.5) | 10 | |
| Somnolence | 9 (12.9) | 14 | 10 (13.2) | 13 | |
| Hypothermia | 6 (8.6) | 8 | 4 (5.3) | 4 | |
| Increased activity* | 6 (8.6) | 12 | 9 (11.8) | 13 | |
| Nausea* | 3 (4.3) | 3 | 11 (14.5) | 13 | |
| Dizziness | 1 (1.4) | 2 | 5 (6.6) | 6 | |
| Breathlessness* | 1 (1.4) | 2 | 1 (1.3) | 1 | |
| Hung-over feeling* | 1 (1.4) | 1 | 0 (0) | 0 | |
| Tremor* | 0 (0) | 0 | 0 (0) | 0 | |
| Seizures | 0 (0) | 0 | 1 (1.3) | 1 | |
| Unprompted adverse events spontaneously reported | |||||
| Fatigue | 8 (11.4) | 14 | 8 (10.5) | 10 | |
| Headache | 10 (14.3) | 12 | 7 (9.2) | 14 | |
| Other | 31 (44.3) | 82 | 40 (52.6) | 107 | |
*Originally included within TESS but removed in April 2009.