Table 8.

Summary of Adverse Events Reported in Randomized Trial by Treatment Group

	System Events		Ocular Events
	Levodopa N=90	Placebo N=49	Levodopa N=90	Placebo N=49
# of adverse events reported	115 events	76 events	8 events	12 events
# of participants (at least 1 event)	53 participants	26 participants	3 participants	2 participants
# of events/randomized participant	1.3	1.6	0.1	0.2
# of visits	783 visits	417 visits	783 visits	417 visits
# of events/visit	0.15	0.18	0.01	0.03
# of serious events	0 events	0 events	0 events	0 events
Effect on study treatment
No change	108 events	73 events	8 events	10 events
Stopped temporarily	5 eventsb	3 eventsc	0 events	2 eventsd
Stopped permanently	2 eventsa	0 events	0 events	0 events
Related to study medication
Yes	42 events	20 events	0 events	10 events
No	73 events	56 events	8 events	2 events

^aLevodopa - Did not resume study medication after 18-week outcome visit due to fatigue (N=1). Father called in 5 weeks after 18-week outcome exam saying child has been acting funny for a couple of days and could not concentrate (N=1). Parents stopped medication before the 26-week visit.

^bLevodopa - Study medication was stopped temporarily due to stomach virus and vomiting for 24 hours (N=1). Study medication was stopped temporarily due to oral surgery for impacted tooth (N=1). Study medication was stopped temporarily due to vomiting, stomach pain, and fever (N=1). Study medication was stopped temporarily due to surgery on face/head to repair lacerations from hitting head when jumping off a dock (N=1). Study medication was stopped temporarily due to stomach virus (N=1).

^cPlacebo - Study medication stopped temporarily after mother called to report frequent generalized stomach pains for 4 days, and vomiting after breakfast (N=1). Study medication stopped temporarily due to nausea and vomiting (N=1). Study medication was stopped temporarily due to “flu-like” symptoms (N=1).

^dPlacebo - Study medication was stopped after 10 weeks when father reported participant blinking uncontrollably (one event for each eye) (N=1).