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Table 3 Patients (%) reporting adverse events, overall and most common (> 2 patients in any treatment group; Safety population)

From: Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD

Patients (%) CHF6001 800 μg BID (N = 58) CHF6001 1600 μg BID (N = 59) Placebo (N = 58)
Adverse events 30 (51.7) 33 (55.9) 26 (44.8)
 Nasopharyngitis 5 (8.6) 6 (10.2) 8 (13.8)
 Cough 1 (1.7) 3 (5.1) 1 (1.7)
 Oropharyngeal pain 3 (5.2) 2 (3.4) 0
 Back pain 4 (6.9) 1 (1.7) 2 (3.4)
 Toothache 3 (5.2) 1 (1.7) 2 (3.4)
 Diarrhoea 3 (5.2) 1 (1.7) 0
 Headache 1 (1.7) 7 (11.9) 1 (1.7)
 Tension headache 1 (1.7) 3 (5.1) 0
 Fatigue 1 (1.7) 3 (5.1) 0
Drug-related adverse events 1 (1.7) 1 (1.7) 0
 Dry mouth 0 1 (1.7) 0
 Sleep disorders 1 (1.7) 0 0
Serious adverse events 2 (3.4) 2 (3.4) 2 (3.4)
Drug-related serious adverse events 0 0 0
Severe adverse events 0 1 (1.7) 1 (1.7)
Adverse events leading to study drug withdrawal 3 (5.2) 2 (3.4) 1 (1.7)
Adverse events with a fatal outcome 0 0 0
  1. Abbreviation: BID twice daily