Table 5.
Comparison of treatment-emergent adverse events (TEAEs) for inhaled ciprofloxacin formulations in BE patients [11–13, 57, 58]
| Adverse event | CDI (28-d) (N = 389) | CDI Placebo (N = 193) | CIP (14-d) (N = 310) | CIP (28-d) (N = 312) | CIP Placebo (N = 311) |
|---|---|---|---|---|---|
| TEAEs | 343 (88.2%) | 182 (94.3%) | 239 (77.1%) | 204 (65.4%) | 230 (74.0%) |
| Respiratory, thoracic, mediastinal disorders | 295 (75.8%) | 158 (81.9%) | 134 (43.2%) | 104 (33.3%) | 127 (40.8%) |
| Cough | 251 (64.5%) | 126 (65.3%) | 20 (6.5%) | 20 (6.4%) | 20 (6.4%) |
| Dyspnea | 211 (54.2%) | 103 (53.4%) | 26 (8.4%) | 20 (6.4%) | 12 (3.9%) |
| Sputum increased | 181 (46.5%) | 108 (56.0%) | NR | NR | NR |
| Wheezing | 153 (39.3%) | 84 (43.5%) | NR | NR | NR |
| Increased viscosity of bronchial secretion | 66 (17.0%) | 37 (19.2%) | NR | NR | NR |
| Hemoptysis | 58 (14.9%) | 27 (14.0%) | 33 (10.6%) | 27 (8.7%) | 32 (10.3%) |
| Oropharyngeal pain | 19 (4.9%) | 20 (10.4%) | NR | NR | NR |
| Rhinorrhea | 14 (3.6%) | 15 (7.8%) | NR | NR | NR |
| Discolored sputum | 13 (3.3%) | 11 (5.7%) | NR | NR | NR |
| Abnormal sputum | 46 (11.8%) | 27 (14.8%) | NR | NR | NR |
| Bronchiectasis | NR | NR | 32 (10.3%) | 33 (10.6%) | 38 (12.2%) |
| Abnormal breath sounds | 103 (26.5%) | 45 (23.3%) | NR | NR | NR |
| Bronchospasm | 5 (1.3%) | 2 (1.0%) | 14 (4.5%) | 10 (3.2%) | 19 (6.1%) |
| General disorders | 237 (60.9%) | 133 (68.9%) | 47 (15.2%) | 39 (12.5%) | 29 (9.3%) |
| Fatigue | 142 (36.5%) | 89 (46.1%) | 14 (4.5%) | 8 (2.6%) | 5 (1.6%) |
| Exercise tolerance decreased | 98 (25.2%) | 55 (28.5%) | NR | NR | NR |
| Pyrexia | 90 (23.1%) | 56 (29.0%) | NR | NR | NR |
| Malaise | 52 (13.4%) | 29 (15.0%) | 7 (2.3%) | 7 (2.2%) | 1 (0.3%) |
| Chest pain | 23 (5.9%) | 9 (4.7%) | NR | NR | NR |
| Chest discomfort | 19 (4.9%) | 10 (5.2%) | NR | NR | NR |
| Infections and infestations | 191 (49.1%) | 111 (57.5%) | 99 (31.9%) | 114 (36.5%) | 106 (34.1%) |
| Sputum purulent | 86 (22.1%) | 50 (25.9%) | NR | NR | NR |
| Nasopharyngitis | 21 (5.4%) | 11 (5.7%) | 32 (10.3%) | 25 (8.0%) | 24 (7.7%) |
| Pneumonia | 20 (5.1%) | 7 (3.6%) | NR | NR | NR |
| URT infection | NR | NR | 17 (5.5%) | 14 (4.5%) | 15 (4.8%) |
| Nervous system disorders | 153 (39.3%) | 72 (37.3%) | 59 (19.0%) | 58 (18.6%) | 30 (9.6%) |
| Lethargy | 88 (22.6%) | 38 (19.7%) | NR | NR | NR |
| Headache | 44 (11.3%) | 25 (13.0%) | 24 (7.7%) | 21 (6.7%) | 9 (2.9%) |
| Dysguesia | 32 (8.2%) | 13 (6.7%) | 14 (4.5%) | 18 (5.8%) | 4 (1.9%) |
| Dizziness | 28 (7.2%) | 9 (4.7%) | 11 (3.6%) | 3 (1.0%) | 3 (1.0%) |
| Gastrointestinal disorders | 92 (23.7%) | 58 (30.1%) | 70 (22.6%) | 56 (17.9%) | 62 (19.9%) |
| Nausea | 30 (7.7%) | 11 (5.7%) | NR | NR | NR |
| Diarrhea | 21 (5.4%) | 19 (9.8%) | 16 (5.2%) | 8 (2.6%) | 10 (3.2%) |
| Musculoskeletal/connective tissue disorders | 93 (23.9%) | 44 (22.8%) | 46 (14.8%) | 43 (13.8%) | 28 (9.0%) |
| Arthralgia | 23 (5.9%) | 9 (4.7%) | 6 (1.9%) | 7 (2.2%) | 3 (1.0%) |
| Back pain | 21 (5.4%) | 6 (3.1%) | NR | NR | NR |
Note that some values less than 5% for CIP were found in the FDA briefing books, and included in the table for comparative purposes
NR not reported (less than 5% threshold)