TABLE 5.

Treatment-emergent adverse events (n=953)

Adverse events	Events, n	Patients, n (%)
Total
Serious adverse events	0	0
Nonserious adverse events	111	78 (8.2)
Causality in relation to ezetimibe
Definitely not or probably not due to ezetimibe	61	53 (5.6)
Probably or definitely due to ezetimibe	50	32 (3.4)
Severity of events associated with ezetimibe
Mild	43	27 (2.8)
Moderate	7	5 (0.5)
Severe	0	0
Most frequently reported (≥0.2%)*
Constipation	7	7 (0.7)
Diarrhea	4	4 (0.4)
Dizziness	6	4 (0.4)
Flatulence	3	3 (0.3)
Myalgia	3	3 (0.3)
Headache	3	3 (0.3)
Dyspepsia	2	2 (0.2)
Nausea	2	2 (0.2)
Fatigue	2	2 (0.2)
Arthralgia	2	2 (0.2)

^*Only events associated with ezetimibe, as per the investigator’s assessment, are presented