Table 4.
Summary of treatment-emergent adverse events
| GOLDEN 2 | GOLDEN 6 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | Glycopyrrolate | Placebo | Glycopyrrolate | Aclidinium | |||||||
| (n = 57) | 12.5 μg BID (n = 55) |
25 μg BID (n = 54) |
50 μg BID (n = 57) |
100 μg BID (n = 59) |
(n = 92) | 3 μg BID (n = 91) |
6.25 μg BID (n = 92) |
12.5 μg BID (n = 90) |
50 μg BID (n = 92) |
400 μg BID (n = 94) |
|
| Any TEAE, n (%) | 15 (26.3) | 19 (34.5) | 18 (33.3) | 18 (31.6) | 17 (28.8) | 11 (12.0) | 22 (24.2) | 23 (25.0) | 24 (26.7) | 14 (15.2) | 24 (25.5) |
| Potentially related TEAEa, n (%) | 0 | 5 (9.1) | 2 (3.7) | 2 (3.5) | 4 (6.8) | 4 (4.3) | 5 (5.5) | 5 (5.4) | 9 (10.0) | 7 (7.6) | 11 (11.7) |
| Serious TEAE, n (%) | 2 (3.5) | 2 (3.6) | 2 (3.7) | 1 (1.8) | 3 (5.1) | 1 (1.1) | 0 | 2 (2.2) | 1 (1.1) | 0 | 3 (3.2) |
| Discontinuations due to TEAE, n (%) | 2 (3.5) | 3 (5.5) | 4 (7.4) | 3 (5.3) | 1 (1.7) | 1 (1.1) | 0 | 0 | 1 (1.1) | 0 | 2 (2.1) |
BID twice daily, TEAE treatment-emergent adverse event
aConsidered by the Investigator to have a definite, probable, or possible relationship to study drug