Summary of TEAEs (safety population, n=511)
| 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 (%) | |
|---|---|---|---|---|---|
| All TEAEs | |||||
| Any TEAE | 57 (44.2) | 71 (55.5) | 80 (62.5) | 69 (54.8) | 277 (54.2) |
| Related TEAEs* | 31 (24.0) | 33 (25.8) | 28 (21.9) | 29 (23.0) | 121 (23.7) |
| Severity of TEAEs | |||||
| Mild | 18 (14.0) | 27 (21.1) | 36 (28.1) | 30 (23.8) | 111 (21.7) |
| Moderate | 32 (24.8) | 32 (25.0) | 38 (29.7) | 29 (23.0) | 131 (25.6) |
| Severe | 5 (3.9) | 12 (9.4) | 5 (3.9) | 10 (7.9) | 32 (6.3) |
| TEAEs leading to discontinuation | 19 (14.7) | 24 (18.8) | 30 (23.4) | 22 (17.5) | 95 (18.6) |
| Any serious TEAEs | 5 (3.9) | 4 (3.1) | 3 (2.3) | 1 (0.8) | 13 (2.5) |
| Related serious TEAEs* | 0 | 1 (0.8) | 2 (1.6) | 1 (0.8) | 4 (0.8) |
| Serious TEAEs leading to discontinuation | 2 (1.6) | 4 (3.1) | 2 (1.6) | 1 (0.8) | 9 (1.8) |
| Most frequent TEAEs (≥5% incidence in any treatment group) | |||||
| UC | 15 (11.6) | 20 (15.6) | 27 (21.1) | 16 (12.7) | 78 (15.3) |
| Headache | 8 (6.2) | 21 (16.4) | 20 (15.6) | 9 (7.1) | 58 (11.4) |
| Abdominal pain | 7 (5.4) | 3 (2.3) | 5 (3.9) | 7 (5.6) | 22 (4.3) |
| Flatulence | 3 (2.3) | 5 (3.9) | 7 (5.5) | 7 (5.6) | 22 (4.3) |
| Nausea | 3 (2.3) | 8 (6.3) | 7 (5.5) | 3 (2.4) | 21 (4.1) |
| Nasopharyngitis | 2 (1.6) | 1 (0.8) | 8 (6.3) | 6 (4.8) | 17 (3.3) |
| Blood cortisol decrease | 1 (0.8) | 7 (5.5) | 3 (2.3) | 4 (3.2) | 15 (2.9) |
*Related—possible, probably or missing.
MMX, Multi-Matrix System; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.