Skip to main content

Table 4 Frequency of adverse events occurring in ≥ 3% of patients in either group, serious adverse events occurring in two or more patients in either group, deaths, discontinuations due to adverse events and electrocardiographic abnormalities

From: Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial

  NVA237 50 μg
(n = 550)
Placebo
(n = 267)
Patients with adverse events, n (%) 317 (57.5) 174 (65.2)
   COPD worsening 111 (20.2) 73 (27.3)
   Nasopharyngitis 28 (5.1) 21 (7.9)
   Cough 26 (4.7) 13 (4.9)
   Upper respiratory tract infection 23 (4.2) 20 (7.5)
   Dyspnoea 18 (3.3) 10 (3.7)
   Pyrexia 17 (3.1) 13 (4.9)
   Upper respiratory tract infection, bacterial 17 (3.1) 12 (4.5)
   Headache 14 (2.5) 10 (3.7)
Patients with serious adverse events*, n (%) 46 (8.4) 24 (9.0)
   COPD worsening 9 (1.6) 11 (4.1)
   Pneumonia 4 (0.7) 2 (0.7)
   Upper respiratory tract infection, bacterial 3 (0.5) 2 (0.7)
   Atrial fibrillation 3 (0.5) 0
   Dyspnoea 2 (0.4) 0
   Respiratory failure 2 (0.4) 0
   Cardiac failure congestive 2 (0.4) 0
   Myocardial infarction 2 (0.4) 1 (0.4)
   Lung neoplasm 2 (0.4) 0
   Syncope 2 (0.4) 0
   Upper respiratory tract infection 0 2 (0.7)
   Myocardial ischaemia 0 2 (0.7)
Deaths**, n (%) 3 (0.5) 3 (1.1)
Discontinuations due to adverse events, n (%) 32 (5.8) 19 (7.1)
Electrocardiographic abnormalities, n (%)   
   Notable QTcF 22 (4.0) 3 (1.1)
   QTcF > 500 ms 0 0
   Increase from baseline of 30-60 ms 59 (10.7) 21 (7.9)
   Increase from baseline of > 60 ms 6 (1.1) 1 (0.4)
  1. * Includes five patients in the NVA237 group that had a serious adverse event that occurred during the 30-day follow-up period. **Includes one patient with a co-existing history of depression in NVA237 group, who died within 30 days after discontinuing from the study due to suicide/depression. > 450 ms for men and > 470 ms for women
  2. QTcF: QTc interval with Fridericia's correction