Table 6.

Summary of potential glucocorticoid-related adverse effects in patients with low cortisol morning plasma concentrations [< 138 nmol/l] at final visit.^a

Effect, n [%]	Budesonide MMX 9mg/d [n = 63]	Budesonide MMX 6mg/d [n = 47]	Budesonide MMX 3mg/d [n = 2]	Placebo [n = 8]
Any glucocorticoid-related adverse effectb	9 [14.3]	2 [4.3]	1 [50.0]	2 [25.0]
Mood changes	4 [6.3]	2 [4.3]	0	1 [12.5]
Acne	2 [3.2]	0	0	0
Fluid retention	1 [1.6]	0	1 [50.0]	0
Hirsutism	1 [1.6]	0	0	0
Insomnia	1 [1.6]	1 [2.1]	0	0
Moon face	1 [1.6]	0	0	0
Sleep changes	1 [1.6]	1 [2.1]	0	2 [25.0]
Flushing	0	0	0	0
Striae rubrae	0	0	0	0

d, day.

^aPatients in randomised, double-blind, phase II and III studies.

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