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Table 2 Frequency and Intensity of TEAEs Overall and TEAEs Occurring in ≥2 Volunteers in Any Treatment Group in Either Study A or B, by MedDRAa Preferred Term (Safety Population)

From: Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies

  Study A Study B
Placebo
n = 6
Navafenterol
300 μg
n = 6
Navafenterol
600 μg
n = 6
Navafenterol
900 μg
nn = 6
Placebo
n = 6
Navafenterol
300 μg
n = 6
Navafenterol
600 μg
n = 6
Navafenterol
900 μg
n = 6
Any TEAE, n (%) 4 (66.7) 3(50.0) 1 (16.7) 5 (83.3) 3 (50.0) 4 (66.7) 5 (83.3) 5 (83.3)
 Mild 4 (66.7) 3 (50.0) 1 (16.7) 5 (83.3) 3 (50.0) 4 (66.7) 4 (66.7) 4 (66.7)
 Moderate 0 2 (33.3) 1 (16.7) 0 0 0 1 (16.7) 1 (16.7)
 Diarrhea 0 0 0 0 1 (16.7) 2 (33.3) 0 3 (50.0)
 Mild 0 0 0 0 1 (16.7) 2 (33.3) 0 3 (50.0)
Vessel puncture site bruiseb 2 (33.3) 0 0 3 (50.0) 0 0 2 (33.3) 0
 Mild 2 (33.3) 0 0 3 (50.0) 0 0 2 (33.3) 0
Headache 0 2 (33.3) 1 (16.7) 0 0 0 0 1 (16.7)
 Mild 0 1 (16.7) 0 0 0 0 0 1 (16.7)
 Moderate 0 1 (16.7) 1 (16.7) 0 0 0 0 0
Dermatitis contact 0 0 0 1 (16.7) 0 0 2 (33.3) 0
 Mild 0 0 0 1 (16.7) 0 0 2 (33.3) 0
Rash 0 0 0 0 1 (16.7) 0 0 2 (33.3)
 Mild 0 0 0 0 1 (16.7) 0 0 2 (33.3)
Nasopharyngitis 0 0 0 2 (33.3) 0 0 0 0
 Mild 0 0 0 2 (33.3) 0 0 0 0
Oropharyngeal pain 2 (33.3) 0 0 0 0 0 0 0
 Mild 2 (33.3) 0 0 0 0 0 0 0
  1. aMedDRA version 19.0
  2. b‘Catheter site bruise’ in study B
  3. MedDRA Medical Dictionary for Regulatory Activities, n number of patients, TEAE treatment emergent adverse event