Worsened potential glucocorticoid-related signs or symptoms occurring during treatment (safety population; n=511)
| Worsened glucocorticoid signs/symptoms* | Placebo (n=129) n (%) | Budesonide MMX 9 mg, (n=128) n (%) | Budesonide MMX 6 mg, (n=128) n (%) | Entocort EC (n=126) n (%) | Total (n=511) n (%) |
|---|---|---|---|---|---|
| Any effect | 13 (10.1) | 8 (6.3) | 6 (4.7) | 14 (11.1) | 41 (8.0) |
| Moon face | 4 (3.1) | 2 (1.6) | 0 | 1 (0.8) | 7 (1.4) |
| Flushing | 1 (0.8) | 0 | 1 (0.8) | 1(0.8) | 3 (0.6) |
| Fluid retention | 2 (1.6) | 0 | 0 | 0 | 2 (0.4) |
| Mood changes | 7 (5.4) | 2 (1.6) | 3 (2.4) | 6 (4.8) | 18 (3.5) |
| Sleep changes | 4 (3.1) | 3 (2.3) | 3 (2.4) | 7 (5.6) | 17 (3.3) |
| Insomnia | 2 (1.6) | 1 (0.8) | 2 (1.6) | 3 (2.4) | 8 (1.6) |
| Acne | 2 (1.6) | 1 (0.8) | 1 (0.8) | 3 (2.4) | 7 (1.4) |
| Hirsutism | 0 | 0 | 0 | 1 (0.8) | 1 (0.2) |
*Worsening of glucocorticoid-related signs or symptoms from baseline to any post-baseline visit.
MMX, Multi-Matrix System.