Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study | NCT01516879

Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study | NCT01516879 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evolocumab	Experimental	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.	Biological: Evolocumab Drug: Atorvastatin Drug: Ezetimibe Other: Diet Only
Placebo	Placebo Comparator	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.	Biological: Placebo Drug: Atorvastatin Drug: Ezetimibe Other: Diet Only

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Biological	Administered by subcutaneous injection once a month	Evolocumab

Outcomes Module

Measure	Description	Time Frame
Percent Change From Baseline in LDL-C at Week 52	Cholesterol was measured by means of ultracentrifugation.	Baseline and Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in LDL-C at Week 52	Cholesterol was measured by means of ultracentrifugation.	Baseline and Week 52
Percentage of Participants With an LDL-C Response at Week 52	An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35216	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29221604	Background	Toth PP, Sattar N, Blom DJ, Martin SS, Jones SR, Monsalvo ML, Elliott M, Davis M, Somaratne R, Preiss D. Effect of Evolocumab on Lipoprotein Particles. Am J Cardiol. 2018 Feb 1;121(3):308-314. doi: 10.1016/j.amjcard.2017.10.028. Epub 2017 Nov 8.
27619750	Background	Blom DJ, Koren MJ, Roth E, Monsalvo ML, Djedjos CS, Nelson P, Elliott M, Wasserman SM, Ballantyne CM, Holman RR. Evaluation of the efficacy, safety and glycaemic effects of evolocumab (AMG 145) in hypercholesterolaemic patients stratified by glycaemic status and metabolic syndrome. Diabetes Obes Metab. 2017 Jan;19(1):98-107. doi: 10.1111/dom.12788. Epub 2016 Oct 14.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
FG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
BG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.6± 10.3 BG00155.9± 10.9 BG00256.1± 10.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000162 BG001312 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0013 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic/Latino

Title	Measurements
	BG00017 BG00133 BG002

Background Therapy

Number

participants

Title

Denominators

Categories

Diet Only

Title	Measurements
	BG00038 BG00174 BG002

Low-density Lipoprotein Cholesterol (LDL-C) Concentration

Cholesterol was measured by means of ultracentrifugation. Data are provided for the Full Analysis Set (all participants who were randomized and received at least 1 dose of study treatment).

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000104.0± 21.6 BG001

Total Cholesterol

Data are provided for the Full Analysis Set

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000179.1± 27.2 BG001176.8± 27.5 BG002

Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration

Data are provided for the Full Analysis Set

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000125.6± 26.9 BG001124.2± 25.6

Apolipoprotein B Concentration

Data are provided for the Full Analysis Set

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG00087.5± 16.3 BG00187.0± 16.3

Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio

Data are provided for the Full Analysis Set

Mean

Standard Deviation

ratio

Title

Denominators

Categories

Title	Measurements
	BG0003.603± 1.11 BG0013.597± 1.04

Apolipoprotein B/Apolipoprotein A-1 Ratio

Data are provided for the Full Analysis Set

Mean

Standard Deviation

ratio

Title

Denominators

Categories

Title	Measurements
	BG0000.586± 0.170 BG0010.593± 0.170

Lipoprotein(a) Concentration

Data are provided for the Full Analysis Set

Mean

Standard Deviation

nmol/L

Title

Denominators

Categories

Title	Measurements
	BG00089.3± 108.6 BG00184.0± 98.5

Triglycerides Concentration

Data are provided for the Full Analysis Set

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000127.8± 65.8 BG001119.8± 63.2

High-density Lipoprotein Cholesterol (HDL-C) Concentration

Data are providedfor the Full Analysis Set

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG00053.5± 16.1 BG00152.6± 15.5

Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration

Data are provided for the Full Analysis Set

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG00021.5± 13.4 BG00120.0± 11.4

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

Percent Change From Baseline in LDL-C at Week 52

Cholesterol was measured by means of ultracentrifugation.

Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000302 OG001599

Title

Denominators

Categories

Title	Measurements
	OG0006.83± 1.75 OG001-50.14± 1.24

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.	Repeated measures linear effects model	The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-56.97	Standard Error of the Mean	2.10	2-Sided	95	-61.08	-52.85			Treatment difference using placebo as the reference.

Secondary

Change From Baseline in LDL-C at Week 52

Cholesterol was measured by means of ultracentrifugation.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With an LDL-C Response at Week 52

An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.

Full Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in LDL-C at Week 12

Cholesterol was measured by means of ultracentrifugation.

Full Analysis set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol at Week 12

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B at Week 52

Full analysis set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lipoprotein(a) at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Triglycerides at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52

Cholesterol was measured by means of ultracentrifugation.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Secondary

Percent Change From Week 12 to Week 52 in LDL-C

Cholesterol was measured by means of ultracentrifugation.

The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.

Posted

Least Squares Mean

Standard Error

percent change

Week 12 and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
OG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Units	Counts
Participants	OG000

Arm/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	Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.			13	302	76	302
EG001	Evolocumab	Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.			33	599	177	599

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected302 at risk EG0012 affected599 at risk
Angina unstable	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Cardiac failure	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0012 affected599 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0012 affected599 at risk
Exostosis of external ear canal	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0012 affected599 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Device breakage	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Non-cardiac chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Appendicitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Skin infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Alanine aminotransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Hepatic enzyme increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0012 affected599 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Migraine with aura	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0010 affected599 at risk
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0011 affected599 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected302 at risk EG0012 affected599 at risk
Breast prosthesis implantation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected302 at risk EG0011 affected599 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00019 affected302 at risk EG00145 affected599 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00029 affected302 at risk EG00163 affected599 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00019 affected302 at risk EG00156 affected599 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00017 affected302 at risk EG00136 affected599 at risk

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-57.8	Standard Error of the Mean	2.3	2-Sided	95	-62.3	-53.3			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.	<0.001		Treatment Difference	75.8			2-Sided	95	70.8	79.7			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-57.51	Standard Error of the Mean	1.56	2-Sided	95	-60.57	-54.45			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-35.15	Standard Error of the Mean	1.04	2-Sided	95	-37.19	-33.11			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-33.45	Standard Error of the Mean	1.41	2-Sided	95	-36.21	-30.68			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-50.27	Standard Error of the Mean	2.03	2-Sided	95	-54.25	-46.28			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-44.21	Standard Error of the Mean	1.71	2-Sided	95	-47.56	-40.85			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-37.14	Standard Error of the Mean	1.67	2-Sided	95	-40.41	-33.87			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-46.21	Standard Error of the Mean	1.82	2-Sided	95	-49.79	-42.63			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-22.35	Standard Error of the Mean	1.94	2-Sided	95	-26.15	-18.55			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-11.54	Standard Error of the Mean	2.89	2-Sided	95	-17.21	-5.86			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	5.42	Standard Error of the Mean	1.09	2-Sided	95	3.28	7.56			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.	<0.001		LS Mean Treatment Difference	-29.15	Standard Error of the Mean	5.64	2-Sided	95	-40.23	-18.08			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	The ANCOVA model includes treatment group and stratification factor as covariates.	0.94		LS Mean Treatment Difference	-0.14	Standard Error of the Mean	1.84	2-Sided	95	-3.76	3.48			Treatment difference using placebo as the reference.		Superiority or Other (legacy)

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

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D001384	Azetidines
D001385	Azetines