Most Common AEs Reported
| Medical Dictionary of Regulatory Activities (MedDRA) Preferred Term | Total Pediatric AE Cases (N = 3251), n (%) |
|---|---|
| Tachycardia | 1378 (42.4) |
| Somnolence | 1177 (36.2) |
| Hallucinations | 1126 (34.6) |
| Ataxia | 832 (25.6) |
| Mydriasis | 802 (24.7) |
| Agitation | 752 (23.1) |
| Hypertension | 609 (18.7) |
| Irritability | 568 (17.5) |
| Confusional state | 555 (17.1) |
| Vomiting | 404 (12.4) |
| Tremor | 345 (10.6) |
| Flushing | 336 (10.3) |
| Psychomotor hyperactivity | 260 (8.0) |
| Pyrexia | 254 (7.8) |
| Nystagmus | 233 (7.2) |
| Lethargy | 198 (6.1) |
| Dystonia | 194 (6.0) |
| Dysarthria | 186 (5.7) |
| Dizziness | 176 (5.4) |