Table 2.
Treatment-emergent adverse events
| Patients with adverse event, n (%) | Wixela Inhub (n = 512) | Advair Diskus (n = 512) | Placebo (n = 103) |
|---|---|---|---|
| Any treatment-emergent adverse event | 72 (14.1) | 75 (14.6) | 15 (14.6) |
| Infections and infestations | 34 (6.6) | 38 (7.4) | 5 (4.9) |
| Respiratory, thoracic, and mediastinal disorders | 15 (2.9) | 25 (4.9) | 7 (6.8) |
| Gastrointestinal disorders | 6 (1.2) | 5 (1.0) | 1 (1.0) |
| Nervous system disorders | 6 (1.2) | 6 (1.2) | 0 |
| Musculoskeletal and connective tissue disorders | 4 (0.8) | 4 (0.8) | 1 (1.0) |
| Injury, poisoning, and procedural complications | 2 (0.4) | 3 (0.6) | 1 (1.0) |
| Cardiac disorders | 3 (0.6) | 0 | 1 (1.0) |
Reported in ≥ 1% patients in the overall study population and/or ≥ 1% of any treatment group