Table 2.
Adverse Events
| Event | Patients [n (%)] (N = 58) |
|---|---|
| Any adverse event reported | 55 (94.8) |
| Any serious adverse event reported | 4 (6.9) |
| Interruption of treatment due to an adverse event | 6 (10.3) |
| Discontinuation of treatment due to an adverse event | 2 (3.4) |
| Adverse events by severity | |
| Mild | 22 (37.9) |
| Moderate | 29 (50.0) |
| Severe | 4 (6.9) |
| Common adverse events (incidence ≥10%) | |
| Cough | 29 (50.0) |
| Nasal congestion | 12 (20.7) |
| Infective pulmonary exacerbation | 12 (20.7) |
| Headache | 12 (20.7) |
| Increased sputum | 8 (13.8) |
| Upper abdominal pain | 8 (13.8) |
| Elevated alanine aminotransferase levels | 7 (12.1) |
| Abdominal pain | 6 (10.3) |
| Nausea | 6 (10.3) |
| Vomiting | 6 (10.3) |
| Fatigue | 6 (10.3) |
| Pyrexia | 6 (10.3) |
| Serious adverse events | |
| Infective pulmonary exacerbation | 2 (3.4) |
| Ileus | 1 (1.7) |
| Elevated liver transaminase levels | 1 (1.7) |
| Respiratory events | 4 (6.9) |
| Dyspnea | 1 (1.7) |
| Respiration abnormal | 1 (1.7) |
| Wheezing | 2 (3.4) |