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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
  1. *Occurring in ≥3 patients in any group.
  2. OD once daily; BID twice daily; AE adverse event; COPD chronic obstructive pulmonary disease; RTI respiratory tract infection.