TEAEs, n (%) | Budesonide (N = 103) | Placebo (N = 103) |
---|---|---|
Subjects with ≥ 1 TEAE | 5 (4.9%) | 8 (7.8%) |
Upper respiratory tract infection | 3 (2.9%) | 3 (2.9%) |
Pharyngitis | 1 (1.0%) | 0 |
Epistaxisa | 0 | 1 (1.0%) |
Nasal congestion | 0 | 1 (1.0%) |
Nasal discomforta | 1 (1.0%) | 0 |
Sneezinga | 1 (1.0%) | 0 |
Cupulolithiasis | 0 | 1 (1.0%) |
Headache | 0 | 1 (1.0%) |
Insomnia | 0 | 1 (1.0%) |