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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.