Table 4 Summary of adverse eventsa (safety population)
PT003011 | PT003012 | ||||
|---|---|---|---|---|---|
GFF MDI 18/9.6 μg (n = 75) | Placebo MDI (n = 72) | TIO SMI 5 μg (n = 73) | GFF MDI 18/9.6 μg (n = 40) | Placebo MDI (n = 40) | |
Patients with ≥1 TEAE | 19 (25.3) | 15 (20.8) | 16 (21.9) | 7 (17.5) | 10 (25.0) |
Patients with ≥1 treatment-related TEAE | 7 (9.3) | 4 (5.6) | 3 (4.1) | 0 | 1 (2.5) |
Patients with ≥1 serious TEAE | 2 (2.7) | 2 (2.8) | 2 (2.7) | 1 (2.5) | 1 (2.5) |
Patients with TEAEs leading to study discontinuation | 3 (4.0) | 1 (1.4) | 1 (1.4) | 1 (2.5) | 1 (2.5) |
Adverse events occurring in ≥2 patients in any group | |||||
Respiratory, thoracic, and mediastinal disorders | 2 (2.7) | 4 (5.6) | 3 (4.1) | 0 | 5 (12.5) |
Dyspnea | 0 | 0 | 1 (1.4) | 0 | 2 (5.0) |
Sinus congestion | 0 | 0 | 0 | 0 | 2 (5.0) |
Cough | 1 (1.3) | 2 (2.8) | 1 (1.4) | 0 | 1 (2.5) |
Infections and infestations | 6 (8.0) | 2 (2.8) | 4 (5.5) | 3 (7.5) | 2 (5.0) |
Furuncle | 0 | 0 | 2 (2.7) | 0 | 0 |
Vascular disorders | 0 | 0 | 0 | 1 (2.5) | 3 (7.5) |
Hypertension | 0 | 0 | 0 | 1 (2.5) | 2 (5.0) |
Gastrointestinal disorders | 5 (6.7) | 4 (5.6) | 5 (6.8) | 0 | 0 |
Constipation | 2 (2.7) | 1 (1.4) | 0 | 0 | 0 |
Vomiting | 0 | 0 | 3 (4.1) | 0 | 0 |
Nervous system disorders | 4 (5.3) | 2 (2.8) | 2 (2.7) | 0 | 0 |
Headache | 1 (1.3) | 2 (2.8) | 1 (1.4) | 0 | 0 |
Tremor | 3 (4.0) | 0 | 0 | 0 | 0 |
Musculoskeletal and connective tissue disorders | 2 (2.7) | 2 (2.8) | 0 | 0 | 0 |
Back pain | 1 (1.3) | 2 (2.8) | 0 | 0 | 0 |