Table 3 Adverse events occurring during 28 days’ treatment with glycopyrronium bromide OD and BID treatment regimens
From: A novel model-based approach for dose determination of glycopyrronium bromide in COPD
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 |