Variable | Budesonide Budesonide (N = 48) | Placebo (N = 43) | P Value |
---|---|---|---|
Patients with any adverse event - no. (%) | 48 (100.0) | 42 (97.7) | nsa |
Any serious adverse event - no. (%) | 13 (27.1) | 13 (30.2) | nsa |
Infectious complications - no. (%) | Â | Â | Â |
Adverse event | 23 (47.9) | 13 (30.2) | 0.085 (ns)a |
Pneumonia | 2 (4.2) | 4 (9.3) | Â |
Sepsis | 3 (6.3) | 0 (0) | Â |
Serious adverse event | 5 (10.4) | 1 (2.3) | 0.207 (ns)b |
Pneumonia | 2 (4.2) | 1 (2.3) | Â |
Sepsis | 2 (4.2) | 0 (0) | Â |