A Study to Evaluate the Efficacy and Safety of Rosuvastat... | NCT02226198

Status Module

Description Module

Label	Type	Description	Intervention Names
Rosuvastatin	Active Comparator	6-week treatment period, and after crossover finished a 12-week efficacy maintenance phase for all patients	Drug: Rosuvastatin 20mg
Placebo	Placebo Comparator	6 weeks treatment during crossover	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin 20mg	Drug	Active drug will be taken taken orally, QD, either in the morning or in the evening	Rosuvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL-Cholesterol (mg/dL)	Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment	Samples taken on Day 42 (week 6) and on day 84 (week 12)
LDL-Cholesterol (mmol/L)	Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment	Samples taken on Day 42 (week 6) and on day 84 (week 12)

Secondary Outcomes

Measure	Description	Time Frame
TC (mg/dL)	Efficacy in terms of total cholesterol (TC)	Samples taken at Day 42 (week 6) and Day 84 (week 12)
TC (mmol/L)	Efficacy in terms of total cholesterol (TC)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prior to any study related procedures being performed, provision of written informed consent from a parent/both parents or guardian and statement of assent from the child or adolescent (if required by Institutional Review Board [IRB] or Independent Ethics Committee [EC] according to local regulations and guidelines). Communication between the Investigator, patient/guardian and child/adolescent to confirm understanding and required compliance with the requirements of the study.
Male and female children and adolescents (aged 6 to <18 years) with at least 1 of the following criteria:

Documentation of genetic testing confirming 2 mutated alleles of the LDL receptor gene locus; and/or

Documented untreated LDL C >500 mg/dL (12.9 mmol/L) and triglyceride (TG) <300 mg/dL (3.4 mmol/L) and at least 1 of the following criteria:
1. Tendinous and/or cutaneous xanthoma prior to 10 years of age; or
2. Documentation of HoFH in both parents by:
  - genetic and/or
  - clinical criteria
Negative pregnancy test (b human chorionic gonadotropin analysis) prior to baseline in females of child bearing potential:
- Female patients of child bearing potential must adhere to a pregnancy prevention method (abstinence, chemical, or mechanical) during the study and 3 months following the last dose.
- Male patients should refrain from fathering a child (including sperm donation) during the study and up to 3 months following the last dose; and
Willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws, and compliance with study treatment regimens.

Exclusion Criteria

History of statin inducted myopathy or serious hypersensitivity reaction to other HMG CoA reductase inhibitors (statins), including rosuvastatin, at Visit 1.
Fasting serum glucose of >9.99 mmol/L (180 mg/dL) or glycosylated hemoglobin >9% at Visit 1 or patients with a history of diabetic ketoacidosis within the past year.
Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) >1.5 times the upper limit of normal (ULN) at Visit 1 or patients whose thyroid replacement therapy was initiated or modified within the last 3 months prior to Visit 2.
Current active liver disease or hepatic dysfunction (except a confirmed diagnosis of Gilbert's disease) as defined as elevations of 1.5 times the upper limit of normal (ULN) for any age in any of the following liver function tests at Visit 1: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or bilirubin.
Definite or suspected personal history or family history of clinically significant adverse drug reactions (ADRs), or hypersensitivity to drugs with a similar chemical structure to rosuvastatin as well as other statins.

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Brussels (Woluwé-St-Lambert)			Belgium
Research Site

PubMed Identifier	Type	Citation	Retractions
28838366	Derived	Stein EA, Dann EJ, Wiegman A, Skovby F, Gaudet D, Sokal E, Charng MJ, Mohamed M, Luirink I, Raichlen JS, Sunden M, Carlsson SC, Raal FJ, Kastelein JJP. Efficacy of Rosuvastatin in Children With Homozygous Familial Hypercholesterolemia and Association With Underlying Genetic Mutations. J Am Coll Cardiol. 2017 Aug 29;70(9):1162-1170. doi: 10.1016/j.jacc.2017.06.058.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Overall	Relevant for the lead-in and maintenance phases
FG001	Rosuva First Then Placebo	Relevant for the cross-over phase

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

LDL-Cholesterol (mg/dL)

Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment

6-17 years HoFH

Posted

Mean

Standard Deviation

mg/dL

Samples taken on Day 42 (week 6) and on day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG00013 OG00113

Title

Denominators

Categories

Title	Measurements
	OG000396.0± 195.99 OG001481.4± 184.90

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	cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta	Mixed Models Analysis		0.005	statistical significance set at 0.05	Relative difference in geometric LSM	-22.3			2-Sided	95	-33.5	-9.1			Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.	No	Superiority or Other

Primary

LDL-Cholesterol (mmol/L)

Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment

6-17 years HoFH

Posted

Mean

Standard Deviation

mmol/L

Samples taken on Day 42 (week 6) and on day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

TC (mg/dL)

Efficacy in terms of total cholesterol (TC)

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

TC (mmol/L)

Efficacy in terms of total cholesterol (TC)

Posted

Mean

Standard Deviation

mmol/L

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

Non-HDL C (mg/dL)

Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

Non-HDL C (mmol/L)

Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)

Posted

Mean

Standard Deviation

mmol/L

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

ApoB (mg/dL)

Efficacy in terms of apolipoprotein B (ApoB)

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

ApoB (g/L)

Efficacy in terms of apolipoprotein B (ApoB)

Posted

Mean

Standard Deviation

g/L

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

HDL-C (mg/dL)

Efficacy in terms of high density lipoprotein cholesterol (HDL C)

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

HDL-C (mmol/L)

Efficacy in terms of high density lipoprotein cholesterol (HDL C)

Posted

Mean

Standard Deviation

mmol/L

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

LDL-C, Not on Apheresis (mg/dL)

Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis

Patients not treated with apheresis

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

LDL-C, Not on Apheresis (mmol/L)

Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis

Patients not treated with apheresis

Posted

Mean

Standard Deviation

mmol/L

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo Not on Apheresis	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

LDL-C From End of Placebo (mg/dL)

Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)

ID	Title	Description
OG000	M-FAS Rosuvastatin	Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
OG001	M-FAS Placebo	Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

LDL-C From End of Placebo (mmol/L)

Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg

Posted

Mean

Standard Deviation

mmol/L

Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)

ID	Title	Description
OG000	M-FAS Rosuvastatin	Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
OG001	M-FAS Placebo	Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

Trough Concentrations

Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.

Posted

Mean

Standard Deviation

ng/mL

Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)

ID	Title	Description
OG000	Cross-over Phase	Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase
OG001	Maintenance Phase	Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.

Units	Counts
Participants	OG000

Secondary

Adverse Events

Safety and tolerability will be described in terms of frequency and severity of adverse events

Posted

Number

adverse events

From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ID	Title	Description
OG000	Lead-in	Optional 10mg lead-in phase, Safety analysis set
OG001	Cross-over Phase	Cross-over phase, Safety analysis set
OG002	Maintenance	Maintenance Phase, Safety analysis set

Units	Counts
Participants	OG000

Secondary

AE's Leading to Discontinuation

Safety and tolerability will be described in terms of rate of discontinuations due to adverse events

Posted

Number

adverse events

From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ID	Title	Description
OG000	Lead-in	Optional 10mg lead-in phase, Safety analysis set
OG001	Cross-over Phase	Cross-over phase, Safety analysis set
OG002	Maintenance Phase	Maintenance phase, Safety analysis set

Units	Counts
Participants	OG000

Secondary

Abnormal Serum Levels

Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found

Posted

Number

participants

From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ID	Title	Description
OG000	Ros/Pla <LLN	Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
OG001	Ros/Pla >ULN	Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
OG002	Pla/Ros <LLN	Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
OG003	Pla/Ros >ULN	Safety Analysis Set, starting cross-over phase with 6 weeks of placebo

Secondary

Height

Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.

Posted

Mean

Standard Deviation

Week 0 (start of cross-over), weeks 6, week 12 and week 18

ID	Title	Description
OG000	Ros/Pla	Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
OG001	Pla/Ros	Safety Analysis Set, starting crossover-phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

Height Z-score

Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.

Posted

Mean

Standard Deviation

ratio

Week 0 (start of cross-over), weeks 6, week 12 and week 18

ID	Title	Description
OG000	Ros/Pla	Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
OG001	Pla/Ros	Safety Analysis Set, starting crossover-phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

Weight

Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.

Posted

Mean

Standard Deviation

Week 0 (start of cross-over), weeks 6, week 12 and week 18

ID	Title	Description
OG000	Ros/Pla	Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
OG001	Pla/Ros	Safety Analysis Set, starting crossover-phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

Tanner Stage

Stages for fem (Pubic hair, Breasts):

(Preadol,Preadol)
(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)
(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)
(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)
(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)

1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.

Posted

Mean

Standard Deviation

stage

Week 0 (start of cross-over)

ID	Title	Description
OG000	Ros/Pla	Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
OG001	Pla/Ros	Safety Analysis Set, starting crossover-phase with 6 weeks of placebo

Units	Counts

Secondary

TG (mg/dL)

Efficacy in terms of triglycerides (TG)

Posted

Mean

Standard Deviation

mg/dL

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

TG (mmol/L)

Efficacy in terms of triglycerides (TG)

Posted

Mean

Standard Deviation

mmol/L

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

LDL C/HDL C

Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)

Posted

Mean

Standard Deviation

ratio

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

TC/HDL C

Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)

Posted

Mean

Standard Deviation

ratio

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

Non-HDL C/HDL C

Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C

Posted

Mean

Standard Deviation

ratio

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

ApoB/ApoA

Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)

Posted

Mean

Standard Deviation

ratio

Samples taken at Day 42 (week 6) and Day 84 (week 12)

ID	Title	Description
OG000	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG001	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

Urinalysis Abnormalitites

Safety and tolerability will be described in terms of abnormal urine laboratory values

Posted

Number

participants

Week 0, week 6, week 12 and week 18

ID	Title	Description
OG000	Ros/Pla	Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
OG001	Pla/Ros	Safety Analysis Set, starting crossover-phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

ECG Abnormalities

Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)

Posted

Number

participants

Week 0

ID	Title	Description
OG000	Safety Analysis Set	Safety Analysis Set
OG001	C-FAS Rosuvastatin	Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
OG002	C-FAS Placebo	Cross-over Full Analysis Set, 6 weeks of Placebo

Units	Counts
Participants	OG000

Secondary

Physical Exam Abnormalitites

Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.

Posted

Number

participants

Screening, Week 0, week 6, week 12 and week 18, week 24

ID	Title	Description
OG000	Ros/Pla	Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
OG001	Pla/Ros	Safety Analysis Set, starting crossover-phase with 6 weeks of placebo

Units	Counts
Participants	OG000

Secondary

Abnormal Vital Signs

Safety and tolerability will be described in terms of abnormal vital signs

Posted

Number

participants

From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ID	Title	Description
OG000	Safety Analysis Set	Safety Analysis Set

Units	Counts
Participants	OG00014

Title	Denominators	Categories

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Influenza like illness	General disorders	Non-systematic Assessment	EG0002 events2 affected11 at risk EG0012 events2 affected14 at risk EG0020 events0 affected13 at risk
Peripheral swelling	General disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected14 at risk EG0020 events0 affected13 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected14 at risk EG0020 events0 affected13 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected14 at risk EG0020 events0 affected13 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected14 at risk EG0020 events0 affected13 at risk
Blood bicarbonate decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected14 at risk EG0021 events1 affected13 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected14 at risk EG0020 events0 affected13 at risk

ID	Term
D006938	Hyperlipoproteinemia Type II
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006951	Hyperlipoproteinemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lead-in	Lead-in	11	4	11
EG001	Cross-over	Cross-over phase	14	4	14
EG002	Maintenance	Maintenance phase	13	1	13

ID	Term
D000090542	Homozygous Familial Hypercholesterolemia
D006949	Hyperlipidemias