Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan

Incidence of adverse events and adverse drug reactions

The incidence of adverse events and drug reactions will be described using the same units (events per 1000 person-years). Adverse events (including seriousness and causal relations to drug or device), inclusive of reaction at local injection sites, and other safety information (e.g. overdose, lack of effectiveness, pregnancy and lactation with or without adverse event) will be described.

Time frame: 2 years

Laboratory values for LDL-C

Time frame: 2 years

Laboratory values for HDL-C

Time frame: 2 years

Laboratory values for total cholesterol

Time frame: 2 years

Laboratory values for triglycerides

Time frame: 2 years

Laboratory values for Apolipoprotein (Apo) A1

This will be measured if feasible.

Time frame: 2 years

Laboratory values for Apolipoprotein (Apo) Apo B

This will be measured if feasible.

Time frame: 2 years

Laboratory values for Apolipoprotein (Apo) Apo E

This will be measured if feasible.

Time frame: 2 years

Laboratory values for lipoprotein(a)

This will be measured if feasible.

Time frame: 2 years