Table 8.
Number (%) of patients who had an adverse event (AE) in any category in the treatment and extension periods, safety population.
| Category of AE | Treatment period | Extension period | ||
|---|---|---|---|---|
| PRM | Placebo | PRM | Placebo | |
| No. of patients | 394 | 395 | 534 | 177 |
| Any AE | 136 (34.5%) | 142 (35.9%) | 394 (73.8%) | 136 (76.8%) |
| Any SAE | 1 (0.3%) | 3 (0.8%) | 15 (2.8%) | 9 (5.1%) |
| SAE leading to death | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.6%) |
| DAE | 9 (2.3%) | 8 (2.0%) | 30 (5.6%) | 12 (6.8%) |
| Drug-related AE* | 17 (5.3%) | 19 (6.1%) | 56 (12.9%) | 24 (17.3%) |
| Drug-related SAE* | 0 (0.0%) | 0 (0.0%) | 1 (0.2%) | 0 (0.0%) |
Percentages based on number of patients in the safety population for each treatment group.
*Assessed by the investigator as definitely, probably or possibly related to study drug.
SAE, serious adverse event; DAE, premature discontinuation of treatment with investigational product due to an AE; PRM, prolonged release melatonin.