Table 3.
Safety outcomes.
| Reported AEs | Placebo Na = 148 | Melatonin Na =160 | p |
|---|---|---|---|
| Nb (%) | Nb (%) | ||
| Related | 31 (20.9) | 44 (27.5) | 1.000 |
| Not Related | 44 (29.7) | 38 (23.8) | 0.290 |
| Related AEs * | |||
| Abnormal dreams | 4 (2.7) | 3 (1.9) | 0.917 |
| Dizziness | 1 (0.7) | 2 (1.2) | 1.000 |
| Dysmenorrhoea | 0 (0.0) | 3 (1.9) | 0.274 |
| Headache | 18 (12.2) | 25 (15.6) | 0.477 |
| Insomnia | 11 (7.4) | 15 (9.4) | 0.684 |
| Somnolence | 2 (1.4) | 14 (8.8) | 0.008 * |
Na = number of participants in the specified group. This is the Safety Population. This value is the denominator for the percentage calculations. Nb = Number of participants reporting at least one occurrence of the specified event category. * Related AEs reported by at least three participants.