TABLE 3.
Most common adverse events (≥5% in any group) occurring in Cycle 1 and in any cycle* (all treated patients)
| n (%) | Cycle 1 | Any cycle | ||
|---|---|---|---|---|
| Tobramycin inhalation powder (n = 46) | Placebo (n = 49) | Tobramycin inhalation powder group [Tobramycin inhalation powder for 3 cycles (n = 46)] | Placebo group [Tobramycin inhalation powder inhalation powder for 2 cycles# (n = 41)] | |
| Any adverse event | 23 (50.0) | 37 (75.5) | 34 (73.9) | 30 (73.2) |
| Cough | 6 (13.0) | 13 (26.5) | 12 (26.1) | 10 (24.4) |
| Lung disorder† | 5 (10.9) | 6 (12.2) | 10 (21.7) | 5 (12.2) |
| Pharyngolaryngeal pain | 5 (10.9) | 0 (0) | 8 (17.4) | 0 (0) |
| Pyrexia | 3 (6.5) | 2 (4.1) | 6 (13.0) | 5 (12.2) |
| Dysgeusia | 3 (6.5) | 1 (2.0) | 4 (8.7) | 4 (9.8) |
| Upper respiratory tract infection | 2 (4.3) | 2 (4.1) | 4 (8.7) | 4 (9.8) |
| Dysphonia | 2 (4.3) | 0 (0) | 3 (6.5) | 4 (9.8) |
| Rhinitis | 2 (4.3) | 2 (4.1) | 3 (6.5) | 1 (2.4) |
| Productive cough | 1 (2.2) | 4 (8.2) | 2 (4.3) | 5 (12.2) |
| Nasopharyngitis | 1 (2.2) | 3 (6.1) | 2 (4.3) | 2 (4.9) |
| Nasal congestion | 1 (2.2) | 1 (2.0) | 4 (8.7) | 2 (4.9) |
| Abdominal pain | 1 (2.2) | 1 (2.0) | 3 (6.5) | 3 (7.3) |
| Hemoptysis | 1 (2.2) | 1 (2.0) | 3 (6.5) | 1 (2.4) |
| Aspartate aminotransferase increased | 1 (2.2) | 0 (0) | 3 (6.5) | 0 (0) |
| Headache | 0 (0) | 3 (6.1) | 2 (4.3) | 2 (4.9) |
*
Each cycle included 28 days on and 28 days off treatment;
#
Adverse events occurring in Cycles 2 and 3 in the placebo group;
†
Lung disorders were generally reported by the investigator as a pulmonary or cystic fibrosis exacerbation