TABLE 4

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

Ciprofloxacin DPIPooled placeboTotal
14days on/off28days on/off
Patients136141137414
Any TE-AE112 (82.4)110 (78.0)114 (83.2)336 (81.2)
Any drug-related TE-AE33 (24.3)35 (24.8)36 (26.3)104 (25.1)
TE-AE with outcome death1 (0.7)2 (1.4)3 (2.2)6 (1.4)
Discontinuation due to TE-AE17 (12.5)14 (9.9)19 (13.9)50 (12.1)
Any serious TE-AE23 (16.9)28 (19.9)32 (23.4)83 (20.0)
Any drug-related serious TE-AE2 (1.5)3 (2.1)1 (0.7)6 (1.4)
TE-AEs reported in at least 5% of patients in any group
 Respiratory, thoracic and mediastinal disorders64 (47.1)62 (44.0)59 (43.1)185 (44.7)
  Bronchiectasis8 (5.9)16 (11.3)17 (12.4)41 (9.9)
  Dyspnoea16 (11.8)16 (11.3)9 (6.6)41 (9.9)
  Haemoptysis16 (11.8)15 (10.6)10 (7.3)41 (9.9)
  Cough13 (9.6)15 (10.6)9 (6.6)37 (8.9)
  Bronchospasm7 (5.1)7 (5.0)10 (7.3)24 (5.8)
  Sputum increased6 (4.4)8 (5.7)3 (2.2)17 (4.1)
  Oropharyngeal pain7 (5.1)3 (2.1)5 (3.6)15 (3.6)
 Infections and infestations50 (36.8)69 (48.9)63 (46.0)182 (44.0)
  Nasopharyngitis16 (11.8)15 (10.6)10 (7.3)41 (9.9)
  Upper respiratory tract infection9 (6.6)4 (2.8)10 (7.3)23 (5.6)
  Sinusitis10 (7.4)4 (2.8)8 (5.8)22 (5.3)
  Pneumonia5 (3.7)7 (5.0)7 (5.1)19 (4.6)
 Gastrointestinal disorders41 (30.1)34 (24.1)36 (26.3)111 (26.8)
  Nausea10 (7.4)5 (3.5)7 (5.1)22 (5.3)
  Diarrhoea9 (6.6)7 (5.0)5 (3.6)21 (5.1)
 Nervous system disorders33 (24.3)31 (22.0)18 (13.1)82 (19.8)
  Headache14 (10.3)11 (7.8)4 (2.9)29 (7.0)
  Dizziness7 (5.1)2 (1.4)1 (0.7)10 (2.4)
 General disorders and administration site conditions33 (24.3)26 (18.4)16 (11.7)75 (18.1)
  Fatigue12 (8.8)6 (4.3)3 (2.2)21 (5.1)
  Chest pain7 (5.1)5 (3.5)7 (5.1)19 (4.6)
 Musculoskeletal and connective tissue disorders28 (20.6)31 (22.0)16 (11.7)75 (18.1)
  Back pain9 (6.6)10 (7.1)6 (4.4)25 (6.0)
  Arthralgia4 (2.9)7 (5.0)1 (0.7)12 (2.9)
 Investigations26 (19.1)16 (11.3)11 (8.0)53 (12.8)
  Aspergillus test positive7 (5.1)6 (4.3)0 (0)13 (3.1)

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 (one in ciprofloxacin DPI 14 days on/off and one in placebo 28 days on/off).