Table 2.
Summary of adverse events (safety population)
| Adverse event [n (%)] | Budesonide foam (n = 719) | Placebo (n = 278) |
|---|---|---|
| Any AE | 298 (41.4) | 101 (36.3) |
| Drug-related AE | 112 (15.6) | 16 (5.8) |
| AE leading to discontinuation | 57 (7.9) | 12 (4.3) |
| Serious AEa | 8 (1.1) | 3 (1.1) |
| Most common AEsb | ||
| Decreased blood cortisol concentration | 66 (9.2) | 6 (2.2) |
| Headache | 45 (6.3) | 7 (2.5) |
| Abdominal pain | 26 (3.6) | 4 (1.4) |
| Nausea | 18 (2.5) | 2 (0.7) |
| Ulcerative proctitis | 0 | 6 (2.2) |
| Glucocorticoid-related AEs | ||
| Acne | 4 (0.6) | 0 |
| Agitation | 1 (0.1) | 0 |
| Depression | 4 (0.6) | 1 (0.4) |
| Insomnia | 3 (0.4) | 1 (0.4) |
| Sleep disorder | 1 (0.1) | 0 |
| Weight increase | 2 (0.3) | 1 (0.4) |
AE adverse event, SAE serious adverse event, UC ulcerative colitis
aSAEs reported in budesonide foam group were: UC in two patients (severe in one patient and moderate in one patient), severe abdominal pain, severe acute exanthematous pustulosis (only drug-related SAE observed), severe arterial thrombosis limb, moderate diarrhea, moderate hypersensitivity, and mild unstable angina in one patient each; in the placebo group: severe anemia, ectopic pregnancy of moderate severity, and moderate UC in one patient each
b ≥2 % of patients in any group