| Mannitol 400 mg twice daily (n=207) | Control 50 mg twice daily (n=134) |
Patients with ≥1 AE | 86.0 | 85.8 |
Patients with ≥1 AE leading to discontinuation from the study | 15.5 | 9.0 |
AEs by MedDRA preferred term (occurring in ≥10% patients overall)# |
Condition aggravated | 37.2 | 41.0 |
Headache | 15.5 | 19.4 |
Cough | 18.8 | 11.9 |
Lower respiratory tract infection | 8.2 | 12.7 |
Bacteria sputum identified | 12.1 | 9.0 |
Nasopharyngitis | 8.7 | 11.2 |
Haemoptysis¶ | 10.6 | 8.2 |
Patients with ≥1 SAE | 22.7 | 26.9 |
SAEs by MedDRA preferred term (occurring in ≥1% patients overall)# |
Condition aggravated | 16.9 | 17.9 |
Haemoptysis | 2.4 | 0.7 |
Lower respiratory tract infection | 1.9 | 2.2 |
Constipation | 0.0 | 1.5 |
Pneumonia | 0.0 | 1.5 |
Intestinal obstruction | 0.0 | 1.5 |
Catheterisation venous | 1.0 | 0.0 |