Table 2.
Most common (≥5% in any group) adverse events occurring in Cycles 1–3 (Safety population).
| n (%) | TIP (n=308) | TIS (n=209) |
|---|---|---|
| Any adverse event | 278 (90.3) | 176 (84.2) |
| Cough | 149 (48.4) | 65 (31.1) |
| Lung disorder† | 104 (33.8) | 63 (30.1) |
| Productive cough | 56 (18.2) | 41 (19.6) |
| Dyspnea | 48 (15.6) | 26 (12.4) |
| Pyrexia | 48 (15.6) | 26 (12.4) |
| Oropharyngeal pain | 43 (14.0) | 21 (10.5) |
| Dysphonia | 42 (13.6) | 8 (3.8) |
| Hemoptysis | 40 (13.0) | 26 (12.4) |
| Headache | 35 (11.4) | 25 (12.0) |
| Nasal congestion | 25 (8.1) | 15 (7.2) |
| Nausea | 23 (7.5) | 20 (9.6) |
| Rales | 22 (7.1) | 13 (6.2) |
| Rhinorrhea | 22 (7.1) | 15 (7.2) |
| Pulmonary function test decreased | 21 (6.8) | 17 (8.1) |
| Upper respiratory tract infection | 21 (6.8) | 18 (8.6) |
| Wheezing | 21 (6.8) | 13 (6.2) |
| Chest discomfort | 20 (6.5) | 6 (2.9) |
| Fatigue | 20 (6.5) | 10 (4.8) |
| Vomiting | 19 (6.2) | 12 (5.7) |
| Sinusitis | 18 (5.8) | 15 (7.2) |
| Pulmonary congestion | 17 (5.5) | 9 (4.3) |
TIP = tobramycin inhalation powder; TIS = tobramycin inhalation solution.
†
Lung disorders were generally reported by the investigator as a pulmonary or cystic fibrosis exacerbation