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Table 4 Treatment-emergent AEs reported in ≥1% of any treatment group (safety population)

From: A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease

   Revefenacin  
Patients with an AE, n (%) Placebo
(n = 71)
44 μg
(n = 68)
88 μg
(n = 71)
175 μg
(n = 71)
350 μg
(n = 74)
Total
(N = 355)
Any AEs 22 (31.0) 16 (23.5) 26 (36.6) 22 (31.0) 23 (31.1) 109 (30.7)
Preferred term
 Headache 2 (2.8) 1 (1.5) 2 (2.8) 1 (1.4) 5 (6.8) 11 (3.1)
 Dyspnea 2 (2.8) 0 3 (4.2) 3 (4.2) 2 (2.7) 10 (2.8)
 Cough 1 (1.4) 0 0 3 (4.2) 3 (4.1) 7 (2.0)
 COPDa 2 (2.8) 0 0 1 (1.4) 2 (2.7) 5 (1.4)
 Back pain 0 0 1 (1.4) 2 (2.8) 1 (1.4) 4 (1.1)
 Oropharyngeal pain 1 (1.4) 1 (1.5) 0 0 2 (2.7) 4 (1.1)
  1. aThis MedDRA PT is used in the event that a patient’s COPD worsens
  2. Abbreviations: AE adverse event, COPD chronic obstructive pulmonary disease, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term