A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study

Table 4

Safety parameters.

Parameter		EZE + Statin	STAT^2
		𝑛=34	𝑛=30
		n (%)^†	n (%)^†
Patients with at least one; nonserious adverse event		4 (11.8)	10 (33.3)
System organ class (SOC)	Preferred term (PT)
Eye disorder	Eye irritation	0 (0.0)	1 (3.3)
Gastrointestinal disorders	Abdominal pain	0 (0.0)	1 (3.3)
	Abdominal discomfort	0 (0.0)	3 (10.0)
General disorders and administration site conditions	Drug intolerance	1 (2.9)	1 (3.3)
Infections and infestations	Influenza	1 (2.9)	0 (0.0)
	Bronchitis	1 (2.9)	0 (0.0)
Investigations	Blood pressure increased	0 (0.0)	1 (3.3)
	Blood creatine kinase increased	0 (0.0)	3 (10.0)
Metabolism and nutrition disorders	Type 2 diabetes mellitus	1 (2.9)	0 (0.0)
Musculoskeletal and connective tissue disorders	Sensation of heaviness	0 (0.0)	1 (3.3)^§
	Myalgia	1 (2.9)	2 (6.7)
	Pain in extremity	0 (0.0)	1 (3.3)
Nervous system disorders	Somnolence	0 (0.0)	1 (3.3)^§

Patients were counted once for the corresponding preferred term and body system.
Adverse events were coded with the Medical Dictionary for Regulatory Activities version 12.0.
^†Percentages are based on the total number of patients in each group.
^§Adverse events occurring in (same) crossover patients.