Table 3.
Summary of AEs and SAEs, Including Individual AEs with Incidence ≥5% in Any Treatment Group, by Baseline Comorbid Anxiety and Depression Status (Safety Population)
| Preferred Term, n (%) | A/D (+) | A/D (–) | ||
|---|---|---|---|---|
| Placebo N=75 | GLY 25 µg BID N=81 | Placebo N=355 | GLY 25 µg BID N=350 | |
| Any AE | 50 (66.7) | 44 (54.3) | 175 (49.3) | 143 (40.9) |
| Cough | 8 (10.7) | 8 (9.9) | 28 (7.9) | 22 (6.3) |
| COPD worsening | 10 (13.3) | 6 (7.4) | 27 (7.6) | 22 (6.3) |
| Gastroenteritis | 4 (5.3) | 1 (1.2) | 2 (0.6) | 1 (0.3) |
| Anxiety | 4 (5.3) | 1 (1.2) | 0 (0) | 1 (0.3) |
| Headache | 4 (5.3) | 1 (1.2) | 6 (1.7) | 6 (1.7) |
| Any SAE | 7 (9.3) | 6 (7.4) | 17 (4.8) | 7 (2.0) |
Abbreviations: AE, adverse event; A/D (+), comorbid anxiety and depression; A/D (–), no comorbid anxiety and depression, or anxiety or depression alone; COPD, chronic obstructive pulmonary disease; BID, twice daily; GLY, nebulized glycopyrrolate; SAE, serious adverse event.