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. 2020 Sep 9;21(Suppl 1):211. doi: 10.1186/s12931-020-01470-5

Table 2.

Summary of TEAEs by Treatment and Dose (Safety Population)

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)

TEAE treatment-emergent adverse event

Adverse events were coded using Medical Dictionary for Regulatory Activities version 18.1

aMost common TEAEs reported by ≥2 patients overall