Table 4 Treatment-emergent AEs reported in ≥1% of any treatment group (safety population)
Revefenacin | ||||||
|---|---|---|---|---|---|---|
Patients with an AE, n (%) | Placebo (n = 71) | 44 μg (n = 68) | 88 μg (n = 71) | 175 μg (n = 71) | 350 μg (n = 74) | Total (N = 355) |
Any AEs | 22 (31.0) | 16 (23.5) | 26 (36.6) | 22 (31.0) | 23 (31.1) | 109 (30.7) |
Preferred term | ||||||
Headache | 2 (2.8) | 1 (1.5) | 2 (2.8) | 1 (1.4) | 5 (6.8) | 11 (3.1) |
Dyspnea | 2 (2.8) | 0 | 3 (4.2) | 3 (4.2) | 2 (2.7) | 10 (2.8) |
Cough | 1 (1.4) | 0 | 0 | 3 (4.2) | 3 (4.1) | 7 (2.0) |
COPDa | 2 (2.8) | 0 | 0 | 1 (1.4) | 2 (2.7) | 5 (1.4) |
Back pain | 0 | 0 | 1 (1.4) | 2 (2.8) | 1 (1.4) | 4 (1.1) |
Oropharyngeal pain | 1 (1.4) | 1 (1.5) | 0 | 0 | 2 (2.7) | 4 (1.1) |