Skip to main content

Table 4 Overall summary of AEs, safety analysis seta

From: Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD: the value of inhaled corticosteroids

  BGF GFF
320/18/9.6 µg 18/9.6 µg
(N = 22) (N = 23)
Any AEs, n (%) 4 (18.2) 6 (26.1)
 Allergy to arthropod sting 0 1 (4.3)
 Aphonia 1 (4.5) 0
 Bronchiolitis 0 1 (4.3)
 Colon cancer 1 (4.5) 0
 Cough 1 (4.5) 0
 Dyspnea 0 2 (8.7)
 Edema peripheral 0 1 (4.3)
 Hypertension 1 (4.5) 0
 Pruritus 0 1 (4.3)
Any AEs with an outcome of death, n (%) 0 0
Any serious TEAEs (including events with outcome of death), n (%) 1 (4.5) 0
 Colon cancer 1 (4.5) 0
Any AE leading to discontinuation of study treatment, n (%) 0 1 (4.3)
 Dyspnea 0 1 (4.3)
Any AEs related to study treatmentb, n (%) 1 (4.5) 3 (13.0)
 Aphonia 1 (4.5) 0
 Bronchiolitis 0 1 (4.3)
 Dyspnea 0 1 (4.3)
 Pruritus 0 1 (4.3)
Any serious AEs related to study treatmentb, n (%) 0 0
  1. aPatients with multiple events in the same category were counted only once in that category. Patients with events in more than one category were counted once in each of those categories
  2. bInvestigator assessed
  3. AE adverse event, BGF budesonide/glycopyrrolate/formoterol fumarate, GFF glycopyrrolate/formoterol fumarate, TEAE treatment-emergent adverse event