TABLE 3

Most Common AEs Reported

Medical Dictionary of Regulatory Activities (MedDRA) Preferred TermTotal Pediatric AE Cases (N = 3251), n (%)
Tachycardia1378 (42.4)
Somnolence1177 (36.2)
Hallucinations1126 (34.6)
Ataxia832 (25.6)
Mydriasis802 (24.7)
Agitation752 (23.1)
Hypertension609 (18.7)
Irritability568 (17.5)
Confusional state555 (17.1)
Vomiting404 (12.4)
Tremor345 (10.6)
Flushing336 (10.3)
Psychomotor hyperactivity260 (8.0)
Pyrexia254 (7.8)
Nystagmus233 (7.2)
Lethargy198 (6.1)
Dystonia194 (6.0)
Dysarthria186 (5.7)
Dizziness176 (5.4)