TABLE 2.
Adverse events during the double‐blind phase (safety population), number of patients (n) (%)
| Budesonide (n = 21) | Placebo (n = 23) | |
|---|---|---|
| Any adverse event | 9 (42.9) | 8 (34.8) |
| Serious adverse event | – | – |
| Adverse events with suspected relation to study drug | 1 (4.8) | 2 (8.7) |
| Adverse events leading to discontinuation of study drug | 1 (4.8) | 2 (8.7) |
| Adverse events occurring in ≥2 patients overall | ||
| Gastrointestinal disorders | 5 (23.8) | 4 (17.4) |
| Abdominal distension | 2 (9.5) | – |
| Gastroesophageal reflux disease | 1 (4.8) | 1 (4.3) |
| Nausea | 1 (4.8) | 1 (4.3) |
| Nervous system disorders | 3 (14.3) | 1 (4.3) |
| Headache | 3 (14.3) | – |
| Infections and infestations | 2 (9.5) | 1 (4.3) |
| Musculoskeletal and connective tissue disorders | 2 (9.5) | 1 (4.3) |
| Investigations | – | 2 (8.7) |
| Skin and subcutaneous tissue disorders | 1 (4.8) | 1 (4.3) |
| Rash | 1 (4.8) | 1 (4.3) |