Table 2.

Summary of adverse events, safety population.

Adverse event, n [%]	Budesonide MMX n = 255	Placebo n = 255
Any AEs	81 [31.8]	69 [27.1]
Drug-related AEs	31 [12.2]	15 [5.9]
Discontinuations due to AE	12 [4.7]	9 [3.5]
Serious AEsa	10 [3.9]	2 [0.8]
Drug-related serious AEsb	2 [0.8]	0
AE intensity
Mild	44 [17.3]	41 [16.1]
Moderate	29 [11.4]	26 [10.2]
Severe	8 [3.1]	2 [0.8]
Most common AEsc
UC	15 [5.9]	10 [3.9]
Decreased blood cortisol levels	10 [3.9]	0
Acne	3 [1.2]	5 [2.0]
Serious AEs
UC	6 [2.4]	1 [0.4]
Acute pancreatitis	1 [0.4]	0
Bronchitis	1 [0.4]	0
Anaemia	1 [0.4]	0
Hypokalaemia	1 [0.4]	0
Type 2 diabetes mellitus	0	1 [0.4]

AE, adverse event; MMX, multimatrix; UC, ulcerative colitis.

^aSerious AEs reported in the budesonide MMX group: UC [n = 6], anaemia [n = 1], acute pancreatitis [n = 1], bronchitis [n = 1], hypokalaemia [n = 1]. Serious AEs reported in the placebo group: UC [n = 1], type 2 diabetes mellitus [n = 1].

^bDrug-related serious AEs included UC and acute pancreatitis.

^cCommon AEs included those reported in ≥ 2% of patients in either group.