Table 4. Most common adverse events (≥5% in any group) across the three studies.
| EAGER | COLO/DPI/02/06 | COLO/DPI/02/05 | ||||
| Tobramycin DPI | Nebulised tobramycin | Colistimethate sodium DPI | Nebulised tobramycin | Colistimethate sodium DPI | Nebulised colistin | |
| Patients# | 308 | 209 | 187 | 193 | 16 | 15 |
| Cough | 149 (48.4) | 65 (31.1) | 168 (89.8) | 151 (78.2) | 13 (81.3) | 7 (46.7) |
| Throat irritation | AiC | AiC | 141 (75.4) | 84 (43.5) | 13 (81.3) | 3 (20.0) |
| Productive cough | 56 (18.2) | 41 (19.6) | 38 (20.3) | 44 (22.8) | 2 (12.5) | 1 (6.7) |
| Dyspnoea | 48 (15.6) | 26 (12.4) | 49 (26.2) | 52 (26.9) | 3 (18.8) | 4 (26.7) |
| Oropharyngeal pain | 43 (14.0) | 21 (10.5) | 4 (2.1) | 1 (0.5) | 2 (12.5) | 2 (13.3) |
| Rales | 22 (7.1) | 13 (6.2) | 2 (1.1) | 5 (2.6) | NR | NR |
| Rhinorrhoea | 22 (7.1) | 15 (7.2) | 1 (0.5) | 2 (1.0) | NR | NR |
| Pulmonary function test decreased | 21 (6.8) | 17 (8.1) | 0 (0) | 3 (1.6) | NR | NR |
| Pyrexia | 48 (15.6) | 26 (12.4) | 23 (12.3) | 19 (9.8) | 2 (12.5) | 1 (6.7) |
| Dysgeusia | AiC | AiC | 117 (62.6) | 53 (27.5) | 14 (87.5) | 3 (20.0) |
| Respiratory disorders | 21 (6.8) | 18 (8.6) | 53 (28.3) | 57 (29.5) | 16 (100) | 7 (46.7) |
| Wheezing | 21 (6.8) | 13 (6.2) | 31 (16.6) | 38 (19.7) | 7 (43.8) | 5 (33.3) |
| Chest discomfort | 20 (6.5) | 6 (2.9) | 26 (13.9) | 34 (17.6) | 4 (25) | 2 (13.3) |
| Sinusitis | 18 (5.8) | 15 (7.2) | 3 (1.6) | 2 (1.0) | NR | NR |
| Pulmonary congestion | 17 (5.5) | 9 (4.3) | NR | NR | NR | NR |
| Dysphonia | 42 (13.6) | 8 (3.8) | 22 (11.8) | 30 (15.5) | NR | NR |
| Nasal congestion | 25 (8.1) | 15 (7.2) | 2 (1.1) | 4 (2.1) | NR | NR |
| Vomiting | 19 (6.2) | 12 (5.7) | 6 (3.2) | 8 (4.1) | 2 (12.0) | 0 (0) |
| Haemoptysis | 40 (13.0) | 26 (12.4) | 20 (10.7) | 13 (6.7) | NR | NR |
| Nausea | 23 (7.5) | 20 (9.6) | 7 (3.7) | 9 (4.7) | NR | NR |
| Headache | 35 (11.4) | 25 (12.0) | 9 (4.8) | 16 (8.3) | 1 (6.3) | 2 (13.3) |
| Fatigue | 20 (6.5) | 10 (4.8) | 9 (4.8) | 8 (4.1) | NR | NR |
| Serious lung disorder | AiC | AiC | NR | NR | NR | NR |
| Chest pain | AiC | AiC | 13 (7.0) | 16 (8.3) | NR | NR |
| Crackles lung | NR | NR | 13 (7.0) | 14 (7.3) | NR | NR |
| Increased upper airway secretion | NR | NR | 12 (6.4) | 13 (6.7) | NR | NR |
| Pharyngitis | NR | NR | 10 (5.3) | 14 (7.3) | NR | NR |
| Rhonchi | NR | NR | 8 (4.3) | 10 (5.2) | NR | NR |
Data are presented as n or n (%). DPI: dry powder inhaler; AiC: academic in confidence; NR: not reported. #: number of patients experiencing the event at least once.