Table 2.

All corticosteroid-associated adverse events in COU-AA-301 and COU-AA-302 (N = 2267)

	Patients, n (%)
	Any grade	Grade ≥3
Any corticosteroid adverse event	558 (24.6)	103 (4.54)
Hyperglycemia	168 (7.4)	48 (2.0)
Weight increase	97 (4.3)	0
Ecchymosis	66 (2.9)	0
Rib fracture	53 (2.3)	2 (0.1)
Cushingoid state	33 (1.5)	0
Cataract	30 (1.3)	10 (0.4)
Diabetes mellitus	26 (1.1)	8 (0.4)
Skin atrophy	23 (1.0)	0
Hematochezia	20 (0.9)	2 (0.1)
Purpura	19 (0.8)	1 (<0.1)
Osteoporosis	20 (0.9)	2 (0.1)
Myopathy	18 (0.8)	2 (0.1)
Spinal compression fracture	14 (0.6)	3 (0.1)
Gastrointestinal hemorrhage	10 (0.4)	7 (0.3)
Osteopenia	10 (0.4)	0
Melena	9 (0.4)	3 (0.1)
Adrenal insufficiency	8 (0.4)	3 (0.1)
Wrist fracture	8 (0.4)	1 (< 0.1)
Hip fracture	5 (0.2)	3 (0.1)
Cataract operation	4 (0.2)	2 (0.1)
Hematemesis	4 (0.2)	1 (<0.1)
Lumbar vertebral fracture	4 (0.2)	1 (<0.1)
Spinal fracture	4 (0.2)	2 (0.1)
Diabetes mellitus (inadequate control)	4 (0.2)	0
Skin fragility	4 (0.2)	0
Feces discolored	4 (0.2)	0
Cervical vertebral fracture	3 (0.1)	2 (0.1)
Gastric ulcer	3 (0.1)	1 (<0.1)
Osteoporotic fracture	3 (0.1)	1 (<0.1)
Thoracic vertebral fracture	3 (0.1)	0
Impaired healing	3 (0.1)	0
Upper gastrointestinal hemorrhage	2 (0.1)	2 (0.1)
Glucose tolerance impaired	2 (0.1)	1 (<0.1)
Skin hemorrhage	2 (0.1)	0
Cushing’s syndrome	2 (0.1)	0
Femoral neck fracture	1 (<0.1)	1 (<0.1)
Central obesity	1 (<0.1)	0
Hemorrhage subcutaneous	1 (<0.1)	0
Skin striae	1 (<0.1)	0
Blood glucose fluctuation	1 (<0.1)	0
Occult blood positive	1 (<0.1)	0
Duodenal ulcer	1 (<0.1)	0
Gastric hemorrhage	1 (<0.1)	0
Gastritis erosive	1 (<0.1)	0
Gastritis hemorrhagic	1 (<0.1)	0
Peptic ulcer	1 (<0.1)	0
Bone loss	1 (<0.1)	0
Pituitary-dependent Cushing’s syndrome	1 (<0.1)	0
Glycosuria	1 (<0.1)	0