CER-001 Therapy as a Novel Approach to Treat Genetic Orph... | NCT02697136

NCT02697136

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CER-001	Experimental	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions	Drug: CER-001
Placebo	Placebo Comparator	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CER-001	Drug	Recombinant human apoA-I/phospholipid complexes	CER-001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery	Change from baseline to Week 24 carotid MVWA; CER-001 versus placebo; measured by 3TMRI	Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery	Change from baseline to Week 8 carotid MVWA; CER-001 versus placebo; measured by 3TMRI	Baseline to Week 8
Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery

Measure	Description	Time Frame
Change in Femoral MVWA	Assessed by 3TMRI; change from baseline; CER-001 versus placebo	Baseline, Weeks 8, 24 and 48

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Erik SG Stroes, MD PhD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site		Salt Lake City	Utah	84108	United States
Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
FG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 13, 2016	Sep 16, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Change from baseline to Week 48 carotid MVWA; CER-001 versus placebo; measured by 3TMRI

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
BG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00110 BG00230

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00054.65(34.5 to 65.7) BG00153.27(43.5 to 62.1) BG00253.79(34.5 to 65.7)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00013 BG0016 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0003 BG0013 BG002

Mutation

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
ApoA-I Mutation Only	BG0008 BG0014 BG002

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

Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery

Change from baseline to Week 24 carotid MVWA; CER-001 versus placebo; measured by 3TMRI

Modified Intent-to-Treat -- All patients randomized to treatment who have baseline and Week 24 carotid 3TMRI performed

Posted

Least Squares Mean

95% Confidence Interval

mm2

Baseline to Week 24

ID	Title	Description
OG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
OG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP

Units	Counts
Participants	OG00017 OG00110

Title

Denominators

Categories

Title	Measurements
	OG000-0.3(-1.0 to 0.4) OG0010.5(-0.4 to 1.4)

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		Mixed Models Analysis		0.185		Difference in LS Means	-0.08			2-Sided	95	-1.9	0.4					Other	Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study. Using an assumed standard deviation of 4.5% and a 2:1 randomization scheme to maximize exposure to active drug, 16 completing patients in the CER-001 group and 8 in the placebo group (24 total completers for mITT) would yield 90% power to detect a difference from baseline versus placebo of 6.7%, using two-tailed testing with α=0.05.

Secondary

Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery

Change from baseline to Week 8 carotid MVWA; CER-001 versus placebo; measured by 3TMRI

Modified Intent-to-Treat -- All patients randomized to treatment who have baseline and Week 8 carotid 3TMRI performed

Posted

Least Squares Mean

95% Confidence Interval

mm2

Baseline to Week 8

ID	Title	Description
OG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
OG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP

Units	Counts
Participants	OG000

Secondary

Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery

Change from baseline to Week 48 carotid MVWA; CER-001 versus placebo; measured by 3TMRI

Modified Intent-to-Treat

Posted

Least Squares Mean

95% Confidence Interval

mm2

Baseline to Week 48

ID	Title	Description
OG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
OG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP

Units	Counts
Participants	OG000

Secondary

Change in Target to Background Ratio (TBR) of the Carotid Artery

Change from baseline to Week 24 in carotid TBR; CER-001 versus placebo; measured by FDG-PET

Carotid MRIs were analyzed for TBR in very few patients. Carotid imaging was performed for during the study, but the images were not read, measured or analyzed for TBR by the central imaging lab following termination of the study and closure of the Sponsor company (Cerenis Therapeutics). No funds were made available by the company's Board of Directors to complete these activities. At that time, paired data (baseline and 24 week) was available for only five patients.

Posted

Mean

Standard Deviation

Ratio

Baseline to Week 24

ID	Title	Description
OG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
OG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP

Units	Counts
Participants

Other Pre-specified

Change in Femoral MVWA

Assessed by 3TMRI; change from baseline; CER-001 versus placebo

Femoral imaging was performed for some patients during the study, but the images were not read, measured or analyzed for Mean Vessel Wall Area by the central imaging lab following termination of the study and closure of the Sponsor company (Cerenis Therapeutics). No funds were made available by the company's Board of Directors to complete these activities.

Posted

Baseline, Weeks 8, 24 and 48

ID	Title	Description
OG000	CER-001	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions CER-001: Recombinant human apoA-I/phospholipid complexes
OG001	Placebo	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CER-001 DB Treatment	CER-001 infusion; 9 weekly infusions followed by 20 biweekly infusions plus 12 biweekly infusions during the optional OL extension CER-001: Recombinant human apoA-I/phospholipid complexes	20	4	20	19	20
EG001	Placebo DB Treatment	Saline infusion; 9 weekly infusions followed by 20 biweekly infusions Placebo: 0.9% Sodium Chloride Injection, USP	10	0	10	9	10
EG002	CER-001 OL Treatment	12 biweekly infusions during the optional OL extension CER-001: Recombinant human apoA-I/phospholipid complexes	26	0	26	9	26

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Angina Unstable	Cardiac disorders	MedDRA (19.1)	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected10 at risk EG00226 at risk
Vascular Stent Stenosis	General disorders	MedDRA (19.1)	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected10 at risk EG00226 at risk
Complication Associated with Device	General disorders	MedDRA (19.1)	Systematic Assessment	Coiling of arterial stent	EG0001 events1 affected20 at risk EG0010 events0 affected10 at risk EG00226 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA (19.1)	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected10 at risk EG00226 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA (19.1)	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected10 at risk EG00226 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected20 at risk EG0013 affected10 at risk EG0022 affected26 at risk
Hordeolum	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0021 affected26 at risk
Cystitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Erysipelas	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Eye Infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Onychomycosis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Sinusitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Tooth Infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Abnormal Faeces	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Faeces Hard	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Lip Dry	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Toothache	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected10 at risk EG0020 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected10 at risk EG0020 affected26 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected10 at risk EG0020 affected26 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Pain in Jaw	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Fatigue	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected20 at risk EG0012 affected10 at risk EG0020 affected26 at risk
Impaired Healing	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Influenza Like Illness	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Infusion Site Bruising	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Malaise	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Oedema Peripheral	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Peripheral Swelling	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Pseudoangina	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Pyrexia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0022 affected26 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected10 at risk EG0020 affected26 at risk
Aphonia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Balance Disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0012 affected10 at risk EG0020 affected26 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Palpitations	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Cartilage Injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Albumin Urine Present	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Heart Rate Irregular	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Red Blood Cells Urine Positive	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
White Blood Cells Urine Positive	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Rask	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Dental Care	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Endodontic Procedure	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Hair Transplant	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk EG0021 affected26 at risk
Peripheral Coldness	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Hypersensitivity	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Lagophthalmos	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk EG0020 affected26 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected10 at risk EG0021 affected26 at risk
Gout	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk
Depression	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk EG0020 affected26 at risk

ID	Term
D052456	Hypoalphalipoproteinemias

Ancestor Terms

ID	Term
D007009	Hypolipoproteinemias
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C000591544	CER-001
D000077330	Saline Solution

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations