Table 4.

Frequency and severity of adverse events

	Patients (N = 326)
Any AEs	272 (83.4%)
Any TEAEs, n (%)	268 (82.2%)
Grade 3	33 (10.1%)
Grade 4	3 (0.9%)
TEAEs reported in ≥ 10% of patients
Hypercholesterolemia	43 (13.2%)
TEAEs related to drug	124 (38.0%)
TEAEs leading to discontinuation	1 (0.3%)
TEAEs leading to death	0
Serious AEs	25 (7.7%)
Grade 3 or 4 laboratory abnormalities	14 (4.3%)
Triglyceride > 5.7 mmol/L	6 (1.8%)
Creatine kinase > 5 × ULN	3 (0.9%)
Calcium < 1.75 mmol/L	2 (0.6%)
Potassium < 3.0 mmol/L	2 (0.6%)
Platelet count < 50 × 109/L	1 (0.3%)

Data are n (%). AEs adverse events, TEAEs treatment-emergent adverse events