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

Table 5 Characterization of adverse events experienced by youth with FXS

Total number of participants¹
Treatment group	No AE	Mild event	Moderate event	Serious event	Between-group comparison
Lovastatin	1	10	1	0	0.3734
Placebo	3	9	4	0
Total number of adverse events²
Treatment Group	Mild event		Moderate event	Serious event	Between-group comparison
Lovastatin	31		1	0	0.2488
Placebo	38		7	0
Total number of adverse events: relationship³
Treatment group	Not related		Unlikely	Probably related	Between-group comparison
Lovastatin	10		12	10	0.8172
Placebo	14		21	20

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
²Total number of adverse events experiencing a certain severity of an adverse event, including recurrence of same adverse event
³Total number of adverse events determined to be related to study drug (lovastatin), including recurrence of same adverse event

ISSN: 1866-1955