AE | Ciprofloxacin DPI | Placebo | p-value |
Subjects n | 60 | 64 | |
Subjects with any AEs | 50 (83.3) | 54 (84.4) | 1.000 |
Patients with any treatment-emergent AEs | 41 (68.3) | 42 (65.6) | 0.849 |
Patients with treatment-related AEs | 21 (35.0) | 17 (26.6) | 0.335 |
Treatment-emergent AEs reported in >5% subjects | |||
Product taste abnormal | 8 (13.3) | 7 (10.9) | 0.786 |
Dysgeusia | 4 (6.7) | 1 (1.6) | 0.197 |
Cough | 0 | 5 (7.8) | 0.058 |
Exacerbation of bronchiectasis | 7 (11.7) | 14 (21.9) | 0.155 |
Headache | 4 (6.7) | 5 (7.8) | 1.000 |
Subjects with treatment-emergent serious AEs# | 2 (3.3) | 3 (4.7) | 1.000 |
Complex pain syndrome | 1 (1.7) | 0 | 0.484 |
Hallucination | 1 (1.7) | 0 | 0.484 |
Exacerbation of bronchiectasis | 0 | 3 (4.7) | 0.245 |
Sepsis | 0 | 1 (1.6) | 1.000 |
Deaths | 0 | 0 |
Data are presented as n (%), unless otherwise stated. DPI: dry powder for inhalation. #: none considered to be drug related.