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Table 8 Number (%) of patients who had an adverse event (AE) in any category in the treatment and extension periods, safety population.

From: Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety

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%)
  1. Percentages based on number of patients in the safety population for each treatment group.
  2. *Assessed by the investigator as definitely, probably or possibly related to study drug.
  3. SAE, serious adverse event; DAE, premature discontinuation of treatment with investigational product due to an AE; PRM, prolonged release melatonin.