Table 4: Safety parameters.

ParameterEZE + StatinSTAT2
n (%)n (%)

Patients with at least one
nonserious adverse event
4 (11.8)10 (33.3)

System organ class (SOC)Preferred term (PT)

Eye disorderEye irritation0 (0.0)1 (3.3)
Gastrointestinal disordersAbdominal pain0 (0.0)1 (3.3)
Abdominal discomfort0 (0.0)3 (10.0)
General disorders and administration site conditionsDrug intolerance1 (2.9)1 (3.3)
Infections and infestationsInfluenza1 (2.9)0 (0.0)
Bronchitis1 (2.9)0 (0.0)
InvestigationsBlood pressure increased0 (0.0)1 (3.3)
Blood creatine kinase increased0 (0.0)3 (10.0)
Metabolism and nutrition disordersType 2 diabetes mellitus1 (2.9)0 (0.0)
Musculoskeletal and connective tissue disordersSensation of heaviness0 (0.0)1 (3.3) §
Myalgia1 (2.9)2 (6.7)
Pain in extremity0 (0.0)1 (3.3)
Nervous system disordersSomnolence0 (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.