Table 3

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 TEAE57 (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
  Mild18 (14.0)27 (21.1)36 (28.1)30 (23.8)111 (21.7)
  Moderate32 (24.8)32 (25.0)38 (29.7)29 (23.0)131 (25.6)
  Severe5 (3.9)12 (9.4)5 (3.9)10 (7.9)32 (6.3)
 TEAEs leading to discontinuation19 (14.7)24 (18.8)30 (23.4)22 (17.5)95 (18.6)
 Any serious TEAEs5 (3.9)4 (3.1)3 (2.3)1 (0.8)13 (2.5)
 Related serious TEAEs*01 (0.8)2 (1.6)1 (0.8)4 (0.8)
 Serious TEAEs leading to discontinuation2 (1.6)4 (3.1)2 (1.6)1 (0.8)9 (1.8)
Most frequent TEAEs (≥5% incidence in any treatment group)
 UC15 (11.6)20 (15.6)27 (21.1)16 (12.7)78 (15.3)
 Headache8 (6.2)21 (16.4)20 (15.6)9 (7.1)58 (11.4)
 Abdominal pain7 (5.4)3 (2.3)5 (3.9)7 (5.6)22 (4.3)
 Flatulence3 (2.3)5 (3.9)7 (5.5)7 (5.6)22 (4.3)
 Nausea3 (2.3)8 (6.3)7 (5.5)3 (2.4)21 (4.1)
 Nasopharyngitis2 (1.6)1 (0.8)8 (6.3)6 (4.8)17 (3.3)
 Blood cortisol decrease1 (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.