Table 5.

Summary of potential glucocorticoid-related adverse effects.

Effect, n [%]	Randomised, double-blind studies				Open-label studies
	Budesonide MMX 9mg/d [n = 270]a	Budesonide MMX 6mg/d [n = 254]	Budesonide MMX 3mg/d [n = 17]	Placebo [n = 293]	Budesonide MMX 9mg/d [n = 60]a
Any potential glucocorticoid-related adverse effectb,c	26 [9.6]	19 [7.5]	1 [5.9]	27 [9.8]	5 [8.3]
Mood changes	9 [3.3]	10 [3.9]	0	11 [4.0]	0
Sleep changes	7 [2.6]	10 [3.9]	0	12 [4.4]	0
Acne	6 [2.2]	2 [0.8]	0	5 [1.8]	1 [1.7]
Insomnia	6 [2.2]	6 [2.4]	0	8 [2.9]	1 [1.7]
Moon face	3 [1.1]	3 [1.2]	0	4 [1.5]	3 [5.0]
Fluid retention	2 [0.7]	3 [1.2]	1 [5.9]	3 [1.1]	1 [1.7]
Hirsutism	1 [0.4]	0	0	0	0
Flushing	0	1 [0.4]	0	3 [1.1]	0
Striae rubrae	0	0	0	2 [0.7]	0

d, day.

^aAdverse events potentially related to the use of glucocorticoids were not prespecified in study CRO-03-53 and thus this population was not included in the analysis.

^bPotential glucocorticoid-related adverse effects presented in descending order of frequency for budesonide MMX 9mg group, then alphabetically for AEs with equal frequency.

^c p > 1.0 for budesonide MMX 9mg vs budesonide MMX 3mg [randomised, double-blind studies].