Table 2.
Incidence of Treatment-Related AEs Reported by ≥1% of Patients
| MF-DPI 400 μg QD PM (n = 611) |
MF-DPI 200 μg BID (n = 622) |
|
|---|---|---|
| Patients reporting any AE, n (%) | 85 (14) | 109 (18) |
| Headache | 10 (2) | 12 (2) |
| Dysphonia | 3 (<1) | 9 (1) |
| Mouth dry | 12 (2) | 11 (2) |
| Mouth ulceration | 5 (1) | 1 (<1) |
| Candidiasis, oral | 9 (1) | 16(3) |
| Pharyngitis | 16 (3) | 15 (2) |
| Upper respiratory tract infection | 5 (1) | 0 |
| Cough | 2 (<1) | 6 (1) |
| Hoarseness | 4 (1) | 5 (1) |
| Throat dry | 11 (2) | 3 (<1) |
| Rash | 0 | 4 (1) |
AE = adverse event; BID = twice-daily; MF-DPI = mometasone furoate administered via a dry powder inhaler; QD PM = once-daily in the evening.