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 |