Table 7.
Adverse Events Occurring in ≥1% of all Children by System Organ Class and Preferred Term (Safety Analysis Set, N = 565)
| System Organ Class Preferred Term | Pseudoephedrine (N = 285), n (%) | Placebo (N = 280), n (%) |
|---|---|---|
| Number of children with at least 1 AE | 220 (77.2) | 209 (74.6) |
| Gastrointestinal disorders | 9 (3.2) | 16 (5.7) |
| Abdominal pain, upper | 5 (1.8) | 4 (1.4) |
| Diarrhea | 0 | 8 (2.9) |
| Vomiting | 2 (0.7) | 5 (1.8) |
| General disorders and administration site conditions | 19 (6.7) | 23 (8.2) |
| Fatigue | 14 (4.9) | 11 (3.9) |
| Pyrexia | 3 (1.1) | 8 (2.9) |
| Nervous system disorders | 206 (72.3) | 180 (64.3) |
| Somnolence | 205 (71.9) | 179 (63.9) |
| Dizziness | 36 (12.6) | 35 (12.5) |
| Headache | 12 (4.2) | 9 (3.2) |
| Psychiatric disorders | 121 (42.5) | 134 (47.9) |
| Insomnia | 98 (34.4) | 109 (38.9) |
| Nervousness | 57 (20.0) | 66 (23.6) |
| Agitation | 3 (1.1) | 3 (1.1) |
| Respiratory, thoracic, and mediastinal disorders | 10 (3.5) | 12 (4.3) |
| Epistaxis | 3 (1.1) | 4 (1.4) |
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities.
MedDRA coding dictionary version 18.1.
If a subject experienced >1 AE, the subject was counted only once in a category. If a subject experienced >1 AE in a system organ class, the subject was counted only once in that system organ class.
Numbers and percentages of events by system organ class include all reported events within the classification, not just those individual events that occurred in ≥1% of all children.