Table 3.
Patients, n (%) | GP MDI 7.2 μg, n=62 | GP MDI 14.4 μg, n=63 | GP MDI 28.8 μg, n=61 | Placebo MDI, n=65 |
---|---|---|---|---|
Patients with ≥1 TEAE | 7 (11.3) | 6 (9.5) | 5 (8.2) | 6 (9.2) |
Patients with TEAEs related to study treatmenta | 1 (1.6) | 1 (1.6) | 0 | 1 (1.5) |
Patients with serious TEAEs | 0 | 0 | 0 | 1 (1.5) |
Patients with serious TEAEs related to study treatmenta | 0 | 0 | 0 | 1 (1.5) |
Patients with TEAEs leading to early discontinuation | 0 | 0 | 0 | 1 (1.5) |
Deaths | 0 | 0 | 0 | 0 |
TEAEs reported in ≥2 patients in any treatment group | ||||
Nasopharyngitis | 1 (1.6) | 2 (3.2) | 0 | 1 (1.5) |
Rash | 0 | 0 | 2 (3.3) | 0 |
Note:
Related = possible, probably, or definitely related to study drug in the opinion of the investigator.
Abbreviations: GP, glycopyrronium; MDI, metered dose inhaler; TEAE, treatment-emergent adverse event.