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Table 2 Summary of TEAEs by Treatment and Dose (Safety Population)

From: Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator

  Placebo navafenterol 50 μg navafenterol 200 μg navafenterol 400 μg navafenterol 900 μg navafenterol 1800 μg navafenterol 2100 μg Overall
N 12 6 6 6 6 6 5 16
Any TEAE, n (%) 7 (58.3) 5 (83.3) 5 (83.3) 3 (50.0) 3 (50.0) 3 (50.0) 2 (40.0) 14 (87.5)
Most common TEAEs, n (%)a
 Headache 3 (25.0) 3 (50.0) 1 (16.7) 2 (33.3) 2 (33.3) 1 (16.7) 0 10 (62.5)
 Nasopharyngitis 1 (8.3) 3 (50.0) 1 (16.7) 0 0 0 2 (40.0) 7 (43.8)
 Chest discomfort 1 (8.3) 1 (16.7) 1 (16.7) 0 0 0 0 3 (18.8)
 Skin irritation 0 1 (16.7) 1 (16.7) 0 0 1 (16.7) 0 3 (18.8)
 Wheezing 1 (8.3) 1 (16.7) 1 (16.7) 0 0 0 0 3 (18.8)
 Cough 0 1 (16.7) 0 0 1 (16.7) 0 0 2 (12.5)
 Dizziness 1 (8.3) 0 1 (16.7) 0 0 0 0 2 (12.5)
 Feeling hot 0 1 (16.7) 0 0 0 0 1 (20.0) 2 (12.5)
 Nausea 0 1 (16.7) 0 0 1 (16.7) 0 0 2 (12.5)
  1. TEAE treatment-emergent adverse event
  2. Adverse events were coded using Medical Dictionary for Regulatory Activities version 18.1
  3. aMost common TEAEs reported by ≥2 patients overall