9. de Boeck 2017 ‐ treatment‐emergent and treatment‐related adverse events.
Event | 400 mg mannitol (n = 87) | Control (n = 87) |
Treatment‐emergent adverse events defined by MeDRa preferred term | ||
Cough | 14 (16.1%) | 14 (16.1%) |
Infective pulmonary exacerbation of cystic fibrosis | 10 (11.5%) | 14 (16.1%) |
Headache | 6 (6.9%) | 7 (8.0%) |
Nasopharyngitis | 6 (6.9%) | 6 (6.9%) |
Lung infection | 2 (2.3%) | 5 (5.7%) |
Treatment related AEs leading to withdrawal from the study | ||
Dizziness | 1 (1.1%) | 0 (0%) |
Cough | 2 (2.3%) | 0 (0%) |
Oropharnygeal pain | 1 (1.1%) | 0 (0%) |
Total number of AEs | 114 | 117 |
Treatment emergent adverse events reported in de Boeck 2017 occurring in at least 5% of participants on either treatment