Table 4– Summary of adverse events (AEs) (modified intent-to-treat/safety population)
AECiprofloxacin DPIPlacebop-value
Subjects n6064
Subjects with any AEs50 (83.3)54 (84.4)1.000
Patients with any treatment-emergent AEs41 (68.3)42 (65.6)0.849
Patients with treatment-related AEs21 (35.0)17 (26.6)0.335
Treatment-emergent AEs reported in >5% subjects
 Product taste abnormal8 (13.3)7 (10.9)0.786
 Dysgeusia4 (6.7)1 (1.6)0.197
 Cough05 (7.8)0.058
 Exacerbation of bronchiectasis7 (11.7)14 (21.9)0.155
 Headache4 (6.7)5 (7.8)1.000
Subjects with treatment-emergent serious AEs#2 (3.3)3 (4.7)1.000
 Complex pain syndrome1 (1.7)00.484
 Hallucination1 (1.7)00.484
 Exacerbation of bronchiectasis03 (4.7)0.245
 Sepsis01 (1.6)1.000
Deaths00
  • Data are presented as n (%), unless otherwise stated. DPI: dry powder for inhalation. #: none considered to be drug related.