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Table 5 Characterization of adverse events experienced by youth with FXS

From: Controlled trial of lovastatin combined with an open-label treatment of a parent-implemented language intervention in youth with fragile X syndrome

Total number of participants1
Treatment groupNo AEMild eventModerate eventSerious eventBetween-group comparison
 Lovastatin110100.3734
 Placebo3940 
Total number of adverse events2
Treatment GroupMild event Moderate eventSerious eventBetween-group comparison
 Lovastatin31 100.2488
 Placebo38 70 
Total number of adverse events: relationship3
Treatment groupNot related UnlikelyProbably relatedBetween-group comparison
 Lovastatin10 12100.8172
 Placebo14 2120 
  1. 1Number of participants experiencing a certain severity of an adverse event where each participant is counted only once at the highest level of severity for the event
  2. 2Total number of adverse events experiencing a certain severity of an adverse event, including recurrence of same adverse event
  3. 3Total number of adverse events determined to be related to study drug (lovastatin), including recurrence of same adverse event