Open Label Study of Long Term Safety Evaluation of Aliroc... | NCT01954394

ID	Type	Description	Link
2013-002572-40	EudraCT Number
U1111-1143-3810	Other Identifier	UTN

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Label	Type	Description	Intervention Names
Alirocumab 75 or 150 mg Q2W	Experimental	Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.	Drug: Alirocumab Drug: Lipid-Modifying Therapy (LMT)

Name	Type	Description	Arm Group Labels	Other Names
Alirocumab	Drug	Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.	Alirocumab 75 or 150 mg Q2W

Measure	Description	Time Frame
Percentage of Participants Who Experienced Adverse Events (AEs)	Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.	Up to 10 weeks after last study drug administration (maximum of 176 weeks)

Measure	Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840321		Huntsville	Alabama	35801	United States
Investigational Site Number 840341

PubMed Identifier	Type	Citation	Retractions
30591415	Derived	Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan-Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.
30293878

ID	Title	Description
FG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 10, 2015	Jun 29, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Experienced Adverse Events (AEs)

Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.

Posted

Number

percentage of participants

Up to 10 weeks after last study drug administration (maximum of 176 weeks)

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG002	Alirocumab: All Participants	All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.

Units	Counts
Participants	OG000330 OG001655 OG002985

Title

Denominators

Categories

Any AE

Title	Measurements
	OG00083.9 OG00187.3 OG00286.2

Any Serious AE

Secondary

Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. "Number analyzed" = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Posted

Mean

Standard Deviation

mg/dL

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

Posted

Mean

Standard Deviation

mmol/L

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time

Posted

Number

percentage of participants

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time

Posted

Number

percentage of participants

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time

Posted

Number

percentage of participants

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 48, 96, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 48, 96, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168

Posted

Mean

Standard Deviation

percent change

Parent Baseline, Weeks 48, 96, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Secondary

Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168

Posted

Mean

Standard Deviation

ratio

Parent Baseline, Weeks 48, 96, 144, and 168

ID	Title	Description
OG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
OG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected330 at risk EG0018 affected655 at risk EG00214 affected985 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected330 at risk EG0015 affected655 at risk EG0029 affected985 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0014 affected655 at risk EG0026 affected985 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0014 affected655 at risk EG0026 affected985 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected330 at risk EG0013 affected655 at risk EG0026 affected985 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0013 affected655 at risk EG0025 affected985 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0013 affected655 at risk EG0024 affected985 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0012 affected655 at risk EG0024 affected985 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected330 at risk EG0011 affected655 at risk EG0024 affected985 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0013 affected655 at risk EG0024 affected985 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0011 affected655 at risk EG0023 affected985 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Aortic valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Pericarditis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hereditary non-polyposis colorectal cancer syndrome	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Corneal decompensation	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Open angle glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Retinal tear	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Retinal vein occlusion	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Internal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Rectal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Volvulus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0014 affected655 at risk EG0026 affected985 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0012 affected655 at risk EG0023 affected985 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Sudden cardiac death	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Vascular stent occlusion	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0013 affected655 at risk EG0025 affected985 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0013 affected655 at risk EG0023 affected985 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Hepatitis E	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Catheter site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Corneal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Cystitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Device related sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Haematoma infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Peritoneal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Postoperative abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Postoperative wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Stitch abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Viral myocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Vascular bypass dysfunction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Heart rate irregular	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Transaminases increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0015 affected655 at risk EG0027 affected985 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0015 affected655 at risk EG0026 affected985 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Acquired claw toe	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Chronic lymphocytic leukaemia stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Laryngeal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Lobular breast carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Metastatic glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ovarian cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Phyllodes tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0016 affected655 at risk EG0027 affected985 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0016 affected655 at risk EG0026 affected985 at risk
Amnesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0010 affected655 at risk EG0022 affected985 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Dementia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Focal dyscognitive seizures	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hemiplegia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Sensory loss	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Vascular dementia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Device defective	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Device loosening	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Alcoholism	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Delirium tremens	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Depressed mood	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Major depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected330 at risk EG0012 affected655 at risk EG0024 affected985 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0013 affected655 at risk EG0024 affected985 at risk
Renal colic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Renal impairment	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Renal pain	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Bartholin's cyst	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Vaginal dysplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0012 affected655 at risk EG0022 affected985 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Neurogenic shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected655 at risk EG0022 affected985 at risk
Air embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Aortic dissection	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected655 at risk EG0021 affected985 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Intermittent claudication	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Malignant hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected655 at risk EG0021 affected985 at risk

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
BG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	4	330	68	330	183	330
EG001	Alirocumab to Alirocumab 75 or 150 mg Q2W	Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	7	655	144	655	366	655
EG002	Alirocumab: All Participants	All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in this study.	11	985	212	985	549	985

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00019 affected330 at risk EG00143 affected655 at risk EG00262 affected985 at risk
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG00012 affected330 at risk EG00140 affected655 at risk EG00252 affected985 at risk
Injection site reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG00026 affected330 at risk EG00128 affected655 at risk EG00254 affected985 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00019 affected330 at risk EG00141 affected655 at risk EG00260 affected985 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00034 affected330 at risk EG00161 affected655 at risk EG00295 affected985 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00031 affected330 at risk EG00171 affected655 at risk EG002102 affected985 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00021 affected330 at risk EG00128 affected655 at risk EG00249 affected985 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00051 affected330 at risk EG00193 affected655 at risk EG002144 affected985 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00034 affected330 at risk EG00153 affected655 at risk EG00287 affected985 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00026 affected330 at risk EG00156 affected655 at risk EG00282 affected985 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00015 affected330 at risk EG00144 affected655 at risk EG00259 affected985 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00018 affected330 at risk EG00131 affected655 at risk EG00249 affected985 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00013 affected330 at risk EG00137 affected655 at risk EG00250 affected985 at risk