Table 3.
Treatment-Emergent Adverse Events by System Organ Class And Preferred Term (Safety Set)
| Patients with AE, n (%) | T (n = 512) | R (n = 512) | Placebo (n = 103) |
|---|---|---|---|
| Any treatment-emergent AE | 72 (14.1) | 75 (14.6) | 15 (14.6) |
| Infections and infestations | 34 (6.6) | 38 (7.4) | 5 (4.9) |
| Upper respiratory tract infection | 7 (1.4) | 11 (2.1) | 0 |
| Nasopharyngitis | 3 (0.6) | 7 (1.4) | 2 (1.9) |
| Respiratory, thoracic, and mediastinal disorders | 15 (2.9) | 25 (4.9) | 7 (6.8) |
| Asthma | 7 (1.4) | 10 (2.0) | 5 (4.9) |
| Oropharyngeal pain | 3 (0.6) | 5 (1.0) | 1 (1.0) |
| Gastrointestinal disorders | 6 (1.2) | 5 (1.0) | 1 (1.0) |
| Nervous system disorders | 6 (1.2) | 6 (1.2) | 0 |
| Headache | 3 (0.6) | 5 (1.0) | 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.
AE, adverse event; R, reference product (Advair Diskus); T, test product (Wixela Inhub).