Table 3.
Most common treatment-related adverse events reported by >2.0% of patients in any treatment group.
| Treatment group (MDI-administered; BID) |
|||||
|---|---|---|---|---|---|
| MF/F | FP/S | MF/F | FP/S | ||
| 200/10 μg | 250/50 μg | 400/10 μg | 500/50 μg | Total | |
| MedDRA Classification, n (%) | (n = 141) | (n = 68) | (n = 130) | (n = 65) | (n = 404) |
| Nervous system disorders | 16(11.3) | 4 (5.9) | 6 (4.6) | 2(3.1) | 28 (6.9) |
| Headache | 6 (4.3) | 4 (5.9) | 4(3.1) | 1 (1.5) | 15 (3.7) |
| Tremor | 4 (2.0) | 0 | 2(1.5) | 2(3.1) | 8 (2.0) |
| Infections/Infestations | 7 (5.0) | 5 (7.4) | 8 (6.2) | 5 (7.7) | 25 (6.2) |
| Bronchitis | 2(1.4) | 2 (2.9) | 3 (2.3) | 1 (1.5) | 8 (2.0) |
| Oral candidiasis | 2(1.4) | 1 (1.5) | 1 (0.8) | 2(3.1) | 6(1.5) |
| Pharyngitis | 2(1.4) | 2 (2.9) | 0 | 1 (1.5) | 5 (1.2) |
| Respiratory, thoracic, mediastinal disorders | 11 (7.8) | 3 (4.4) | 6 (4.6) | 0 | 20 (5.0) |
| Dysphonia | 7 (5.0) | 0 | 4(3.1) | 0 | 11 (2.7) |
| Gastrointestinal disorders | 7 (5.0) | 5 (7.4) | 4(3.1) | 2(3.1) | 18 (4.5) |
| Aphthous stomatitis | 3 (2.1) | 0 | 1 (0.8) | 0 | 4 (1.0) |
| Dysphagia | 0 | 2 (2.9) | 0 | 0 | 2 (0.5) |
| Musculoskeletal and connective tissue disorders | 4 (2.8) | 3 (4.4) | 4(3.1) | 3 (4.6) | 14 (3.5) |
| Arthralgia | 2(1.4) | 3 (4.4) | 1 (0.8) | 1 (1.5) | 7 (1.7) |
| Muscle spasms | 1 (0.7) | 1 (1.5) | 2(1.5) | 2(3.1) | 6(1.5) |
| Eye disorders | 3 (2.1) | 1 (1.5) | 5 (3.8) | 0 | 9 (2.2) |
| Lens disorders | 0 | 1 (1.5) | 3 (2.3) | 0 | 4(1.0) |
BID, twice daily; FP/ /salmeterol; MDI, metered-dose inhaler; MedDRA, Medical Dictionary for Regulatory Activities; MF/F, mometasone furoate/formoterol.