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) |