Table 3.

Adverse events.

	Placebo [N = 54]	Budesonide foam QD [N = 55]	Budesonide foam BID [N = 56]
Summary of adverse events, n [%]
Adverse events	16 [29.6]	26 [47.3]	38 [67.9]
Study drug-related adverse events	6 [11.1]	17 [30.9]	30 [53.6]
Death	0 [0.0]	0 [0.0]	0 [0.0]
Serious adverse events	0 [0.0]	0 [0.0]	0 [0.0]
Adverse events leading to treatment discontinuation	2 [3.7]	0 [0.0]	2 [3.6]
Common adverse eventsa, n [%]
Infections and infestations	-	-	-
Nasopharyngitis	3 [5.6]	6 [10.9]	4 [7.1]
Nervous system disorders	-	-	-
Headache	1 [1.9]	-	6 [10.7]
Gastrointestinal disorders	-	-	-
Vomiting	-	-	2 [3.6]
Colitis ulcerative	2 [3.7]	-	1 [1.8]
General disorders and administration site conditions	-	-	-
Pyrexia	2 [3.7]	2 [3.6]	-
Investigations	-	-	-
Plasma cortisol decrease	-	12 [21.8]	26 [46.4]
Plasma corticotrophin decrease	-	8 [14.5]	16 [28.6]
Blood creatine phosphokinase increase	-	2 [3.6]	-

^a Defined as an adverse event that occurred in at least two patients in any group.

BID, twice a day administration; QD, once daily administration.