Table 3 Adverse events, overall and most common (safety analysis set)
From: A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD
Ensifentrine | Placebo (N = 79) | ||||
|---|---|---|---|---|---|
0.75 mg (N = 81) | 1.5 mg (N = 81) | 3 mg (N = 82) | 6 mg (N = 80) | ||
Any adverse event | 27 (33) | 36 (44) | 29 (35) | 29 (36) | 31 (39) |
Headache | 4 (5) | 4 (5) | 7 (9) | 4 (5) | 3 (4) |
Worsening of COPD symptoms | 5 (6) | 5 (6) | 3 (4) | 3 (4) | 6 (8) |
Cough | 4 (5) | 4 (5) | 6 (7) | 1 (1) | 1 (1) |
Nasopharyngitis | 2 (2) | 4 (5) | 4 (5) | 5 (6) | 7 (9) |
Hypertension | 2 (2) | 1 (1) | 4 (5) | 3 (4) | 1 (1) |
Nausea | 3 (4) | 2 (2) | 2 (2) | 0 | 2 (3) |
Dyspnoea | 3 (4) | 1 (1) | 1 (1) | 1 (1) | 5 (6) |
Productive cough | 0 | 3 (4) | 1 (1) | 0 | 0 |
Any treatment-related adverse event | 8 (10) | 11 (14) | 12 (15) | 8 (10) | 10 (13) |
Cough | 2 (2) | 1 (1) | 4 (5) | 1 (1) | 1 (1) |
Dyspnoea | 1 (1) | 0 | 0 | 0 | 3 (4) |
Productive cough | 0 | 3 (4) | 0 | 0 | 0 |
Any severe adverse event | 4 (5) | 1 (1) | 2 (2) | 1 (1) | 2 (3) |
Any serious adverse event | 2 (2) | 2 (2) | 1 (1) | 1 (1) | 1 (1) |
Any serious treatment-related adverse event | 1 (1) | 1 (1) | 0 | 0 | 0 |
Any adverse event leading to drug discontinuation | 6 (7) | 1 (1) | 4 (5) | 2 (3) | 2 (3) |
Any adverse event leading to death | 0 | 1 (1) | 0 | 1 (1) | 0 |