Table 4.
Most frequent adverse events by preferred term (≥5% of total number of events)
| CDPI (n=186*) | TIS (n=193) | Total (n=379) | |
|---|---|---|---|
| Patients experiencing an AE | 175 (93.6) | 172 (89.1) | 347 (91.3) |
| Patients experiencing a treatment-related AE | 153 (81.8) | 90 (46.6) | 243 (63.9) |
| Withdrawals due to an AE | 22 (11.8) | 5 (2.6) | 27 (7.1) |
| Severity | |||
| Mild | 159 (85.0) | 165 (85.5) | 324 (85.3) |
| Moderate | 123 (65.8) | 97 (50.3) | 220 (57.9) |
| Severity | 48 (25.7) | 13 (6.7) | 61 (16.1) |
| Total number of adverse events | 1232 | 1194 | 2426 |
| Preferred term | |||
| Cough | 193 (15.7) | 123 (10.3) | 316 (13.0) |
| Abnormal taste | 132 (10.7) | 62 (5.2) | 194 (8.0) |
| Dyspnoea | 81 (6.6) | 98 (8.2) | 179 (7.4) |
| Lower respiratory tract infection | 79 (6.4) | 85 (7.1) | 164 (6.8) |
| Throat irritation | 94 (7.6) | 63 (5.3) | 157 (6.5) |
| Productive cough | 62 (5.0) | 76 (6.4) | 138 (5.7) |
Data presented as n (%), safety population.
*One patient was randomised but received no treatment.
AE, adverse event; CDPI, Colobreathe dry powder for inhalation; TIS, tobramycin inhaler solution.