Summary of treatment-emergent AEs (safety population)
| Dose 32.5 mg | Dose 48.75 mg | |||
|---|---|---|---|---|
| MedDRA-preferred term | Ciprofloxacin DPI N=93 n (%) | Placebo N=65 n (%) | Ciprofloxacin DPI N=93 n (%) | Placebo N=35 n (%) |
| Any AE | 68 (73.1) | 53 (81.5) | 81 (87.1) | 29 (82.9) |
| Any drug-related AE | 35 (37.6) | 22 (33.8) | 46 (49.5) | 10 (28.6) |
| Drug-related AEs in >5% participants in any treatment group | ||||
| Product taste abnormal | 7 (7.5) | 4 (6.2) | 16 (17.2) | 2 (5.7) |
| Dysgeusia | 13 (14.0) | 4 (6.2) | 9 (9.7) | 1 (2.9) |
| Cough | 3 (3.2) | 7 (10.8) | 2 (2.2) | 3 (8.6) |
| Gastrointestinal disorders* | 3 (3.2) | 2 (3.1) | 5 (5.4) | 1 (2.9) |
| Sputum increased | 0 | 1 (1.5) | 2 (2.2) | 2 (5.7) |
| Chest discomfort | 1 (1.1) | 4 (6.2) | 1 (1.1) | 0 |
| Any serious AE† | 4 (4.3) | 4 (6.2) | 11 (11.8) | 2 (5.7) |
| Any drug-related serious AE† | 0 | 1 (1.5) | 3 (3.2) | 0 |
| Pancreatitis | 0 | 0 | 1 (1.1) | 0 |
| Infective pulmonary exacerbation of CF | 0 | 0 | 1 (1.1) | 0 |
| Bronchospasm | 0 | 0 | 1 (1.1) | 0 |
| Haemoptysis | 0 | 1 (1.5) | 2 (2.2) | 0 |
| AEs of particular interest | ||||
| Drug-induced bronchospasm (≥15% drop in FEV1 following drug administration) | 3 (3.2) | 3 (4.6) | 3 (3.2) | 0 |
| Premature discontinuation due to AE | 10 (10.8) | 9 (13.8) | 15 (16.1) | 10 (28.6) |
| Deaths | 0 | 0 | 0 | 0 |
Multiple occurrences of the same event in the same subject are only counted once.
*Refers to MedDRA SOC. All drug-related AEs within this SOC occurred at a frequency of <5% in the individual treatment groups.
†Serious AEs were defined as AEs that were life-threatening, that required inpatient hospitalisation or prolongation of existing hospitalisation, that resulted in persistent or significant disability or death, or that was a congenital anomaly, birth defect, or an important medical event.
AE, adverse event; CF, cystic fibrosis; DPI, dry powder for inhalation; FEV1, forced expiratory volume in 1 s; MedDRA, medical dictionary for regulatory activities; SOC, system organ class.