Table 3.
Adverse events occurring during 28 days’ treatment with glycopyrronium bromide OD and BID treatment regimens
| n (%) patients | Glycopyrronium bromide 12.5 μg OD (n = 89) | Glycopyrronium bromide 25 μg OD (n = 96) | Glycopyrronium bromide 12.5 μg BID (n = 96) | Glycopyrronium bromide 50 μg OD (n = 92) | Glycopyrronium bromide 25 μg BID (n = 96) | Glycopyrronium bromide 100 μg OD (n = 96) | Glycopyrronium bromide 50 μg BID (n = 87) | Placebo (n = 91) |
|---|---|---|---|---|---|---|---|---|
| Any AE |
24 (27.0) |
20 (20.8) |
17 (17.7) |
26 (28.3) |
23 (24.0) |
27 (28.1) |
20 (23.0) |
29 (31.9) |
| Any serious AE |
2 (2.2) |
2 (2.1) |
1 (1.0) |
3 (3.3) |
4 (4.2) |
3 (3.1) |
1 (1.1) |
3 (3.3) |
| Serious AE leading to discontinuation |
2 (2.2) |
1 (1.0) |
1 (1.0) |
1 (1.1) |
2 (2.1) |
2 (2.1) |
0 |
2 (2.2) |
| Most common AEs by preferred term* | ||||||||
| Nasopharyngitis |
4 (4.5) |
8 (8.3) |
2 (2.1) |
4 (4.3) |
3 (3.1) |
4 (4.2) |
5 (5.7) |
6 (6.6) |
| COPD worsening |
7 (7.9) |
3 (3.1) |
2 (2.1) |
0 |
5 (5.2) |
3 (3.1) |
1 (1.1) |
4 (4.4) |
| Headache |
1 (1.1) |
1 (1.0) |
2 (2.1) |
3 (3.3) |
3 (3.1) |
4 (4.2) |
3 (3.4) |
6 (6.6) |
| Dyspnoea |
0 |
2 (2.1) |
3 (3.1) |
3 (3.3) |
2 (2.1) |
1 (1.0) |
4 (4.6) |
0 |
| Cough |
3 (3.4) |
3 (3.1) |
1 (1.0) |
0 |
1 (1.0) |
3 (3.1) |
0 |
2 (2.2) |
| Diarrhoea |
1 (1.1) |
2 (2.1) |
3 (3.1) |
0 |
1 (1.0) |
0 |
2 (2.3) |
0 |
| Dry mouth |
0 |
0 |
0 |
1 (1.1) |
2 (2.1) |
2 (2.1) |
2 (2.3) |
1 (1.1) |
| Lower RTI | 0 | 0 | 1 (1.0) | 0 | 3 (3.1) | 1 (1.0) | 0 | 0 |
*Occurring in ≥3 patients in any group.
OD once daily; BID twice daily; AE adverse event; COPD chronic obstructive pulmonary disease; RTI respiratory tract infection.