TABLE 4

Treatment-emergent adverse events (TE-AEs)# (MedDRA classifications)

Ciprofloxacin DPIPooled placeboTotal
14days on/off28days on/off
Patients174171174519
Any TE-AE127 (73.0)94 (55.0)116 (66.7)337 (64.9)
Any drug-related TE-AE28 (16.1)19 (11.1)24 (13.8)71 (13.7)
TE-AE with outcome death3 (1.7)4 (2.3)2 (1.1)9 (1.7)
Discontinuation due to TE-AE10 (5.7)6 (3.5)10 (5.7)26 (5.0)
Any serious TE-AE45 (25.9)28 (16.4)41 (23.6)114 (22.0)
Any drug-related serious TE-AE01 (0.6)01 (0.2)
TE-AE reported in at least 5% of patients in any group
 Respiratory, thoracic and mediastinal disorders70 (40.2)42 (24.6)68 (39.1)180 (34.7)
  Bronchiectasis24 (13.8)17 (9.9)21 (12.1)62 (11.9)
  Haemoptysis17 (9.8)12 (7.0)22 (12.6)51 (9.8)
  Cough7 (4.0)5 (2.9)11 (6.3)23 (4.4)
  Bronchospasm7 (4.0)3 (1.8)9 (5.2)19 (3.7)
  Dyspnoea10 (5.7)4 (2.3)3 (1.7)17 (3.3)
 Infections and infestations49 (28.2)45 (26.3)43 (24.7)137 (26.4)
  Nasopharyngitis16 (9.2)10 (5.8)14 (8.0)40 (7.7)
  Upper respiratory tract infections8 (4.6)10 (5.8)5 (2.9)23 (4.4)
 Gastrointestinal disorders29 (16.7)22 (12.9)26 (14.9)77 (14.8)
 Nervous system disorders25 (14.4)26 (15.2)12 (6.9)63 (12.1)
  Headache10 (5.7)10 (5.8)5 (2.9)25 (4.8)
  Dysgeusia8 (4.6)9 (5.3)2 (1.1)19 (3.7)
 General disorders and administration site conditions14 (8.0)14 (8.2)13 (7.5)41 (7.9)
 Musculoskeletal and connective tissue disorders18 (10.3)12 (7.0)10 (5.7)40 (7.7)
 Skin and subcutaneous tissue disorders12 (6.9)8 (4.7)11 (6.3)31 (6.0)
 Investigations13 (7.5)6 (3.5)10 (5.7)29 (5.6)
 Metabolism and nutrition disorders11 (6.3)5 (2.9)8 (4.6)24 (4.6)
 Vascular disorders9 (5.2)5 (2.9)6 (3.4)20 (3.9)

Data are presented as n or n (%). MedDRA: Medical Dictionary for Regulatory Activities; DPI: dry powder for inhalation. #: defined as those that first occurred or worsened during the study from the first administration of study medication (ciprofloxacin DPI or placebo) until 30 days after administration of the last dose of study medication; : two randomised subjects did not receive study medication (both in ciprofloxacin DPI 14 days on/off).