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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