Table 4.
Adverse Events and Serious Adverse Events
| Type of Event | INCS | Placebo |
|---|---|---|
| Adverse events, total | ||
| Asthma exacerbation | 3 | 18 |
| Lower respiratory tract | 8 | 6 |
| Upper respiratory tract (including ears) | 67 | 90 |
| Cough | 15 | 11 |
| GI tract | 11 | 12 |
| Dehydration | 3 | 1 |
| ADHD diagnosis | 3 | 4 |
| Other infections (not included in other listed categories) | 17 | 40 |
| Hypersomnolence | 1 | 2 |
| Sleep apnea symptom exacerbation | 0 | 6 |
| Other | 27 | 34 |
| Total | 155 | 224 |
| Serious adverse events | ||
| Asthma | 0 | 3 |
| Lower respiratory tract | 1 | 0 |
| Total | 1 | 4 |
ADHD = attention-deficit/hyperactivity disorder; INCS = intranasal corticosteroids.