Table 2.

Adverse events

	From week 0 to week 6		From week 6 to week 12c
	Placebo (n = 62)	Budesonide foam (n = 64)	Placebo (n = 19)	Budesonide foam (n = 20)
Summary of adverse events, n (%)
Adverse events	25 (40.3)	29 (45.3)	4 (21.0)	6 (30.0)
Study drug-related adverse events	6 (9.7)	11 (17.2)	2 (10.5)	1 (5.0)
Death	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Serious adverse events	1 (1.6)	1 (1.6)	0 (0.0)	0 (0.0)
Adverse events leading to treatment discontinuation	2 (3.2)	4 (6.3)	0 (0.0)	0 (0.0)
Common adverse events, n (%)a
Infections and infestations
Nasopharyngitis	3 (4.8)	7 (10.9)	0 (0.0)	1 (5.3)
Upper respiratory tract infection	0 (0.0)	0 (0.0)	1 (5.3)	0 (0.0)
Tinea pedis	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)
Nervous system disorders
Headache	3 (4.8)	2 (3.1)	0 (0.0)	0 (0.0)
Vascular disorders
Hypertension	1 (1.6)	3 (4.7)	0 (0.0)	0 (0.0)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	7 (11.3)	1 (1.6)	1 (5.3)	0 (0.0)
Asthma	2 (3.2)	0 (0.0)	0 (0.0)	0 (0.0)
Gastrointestinal disorders
Vomiting	0 (0.0)	2 (3.1)	0 (0.0)	0 (0.0)
Gastric ulcer	0 (0.0)	0 (0.0)	1 (5.3)	0 (0.0)
Stomatitis	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)
Frequent bowel movements	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)
Skin and subcutaneous tissue disorders
Eczema	0 (0.0)	1 (1.6)	1 (5.3)	0 (0.0)
Rash	0 (0.0)	1 (1.6)	0 (0.0)	1 (5.3)
General disorders and administration site conditions
Pyrexia	0 (0.0)	2 (3.1)	1 (5.3)	1 (5.3)
Investigationsb
Blood creatine phosphokinase increased	0 (0.0)	2 (3.1)	0 (0.0)	0 (0.0)
Blood uric acid increased	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)

^aDefined as an adverse event that occurred in at least 2% of patients in any group

^bExcept plasma cortisol or plasma ACTH decrease

^cAdverse events newly developing during the period from week 6 to week 12