Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on... | NCT00770146

Name	Class
Ionis Pharmaceuticals, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo subcutaneous injection once a week for 26 weeks.	Drug: Placebo
Mipomersen	Experimental	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.	Drug: Mipomersen sodium

Name	Type	Description	Arm Group Labels	Other Names
Mipomersen sodium	Drug	200 mg/mL	Mipomersen	ISIS 301012

Measure	Description	Time Frame
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point	LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald's calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.	Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).
Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point	The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.	Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

Measure	Description	Time Frame
Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point	Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.	Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

Measure	Description	Time Frame
Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point	Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.	Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35209	United States

PubMed Identifier	Type	Citation	Retractions
25614280	Derived	Santos RD, Raal FJ, Catapano AL, Witztum JL, Steinhagen-Thiessen E, Tsimikas S. Mipomersen, an antisense oligonucleotide to apolipoprotein B-100, reduces lipoprotein(a) in various populations with hypercholesterolemia: results of 4 phase III trials. Arterioscler Thromb Vasc Biol. 2015 Mar;35(3):689-99. doi: 10.1161/ATVBAHA.114.304549. Epub 2015 Jan 22.
24013058

ID	Title	Description
FG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
FG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

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 Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point

LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald's calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.

Posted

Median

Inter-Quartile Range

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG00050 OG001101

Title

Denominators

Categories

Title	Measurements
	OG000-3.4± 24.22(-14.8 to 11.8) OG001-40.2± 26.85(-56.4 to -19.1)

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	Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.	Wilcoxon (Mann-Whitney)		<0.001	Statistical significance was concluded if p ≤ 0.05.												No	Superiority or Other

Primary

Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point

Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Secondary

Apolipoprotein B at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point

Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Secondary

Total Cholesterol at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point

Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Secondary

Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point

Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Triglycerides at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at the Primary Efficacy Time Point

High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point

Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point

Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Median

Inter-Quartile Range

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point

The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

ratio

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point

Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

percentage of baseline

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Full analysis set

Posted

Mean

Standard Deviation

mg/dL

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
OG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0015 affected105 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0014 affected105 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Atrial flutter	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Atrioventricular block	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Cardiac discomfort	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Palpitations	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0014 affected105 at risk
Tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Adrenal mass	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Goitre	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hypothyroidism	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Blepharitis	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Cataract nuclear	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Ectropion	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Eyelid oedema	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Keratopathy	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Visual impairment	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0012 affected105 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0011 affected105 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Colitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0012 affected105 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG0017 affected105 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG0014 affected105 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Flatulence	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0011 affected105 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0013 affected105 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG00111 affected105 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Pancreatic atrophy	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Regurgitation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Toothache	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0014 affected105 at risk
Asthenia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Chest discomfort	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Chills	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0018 affected105 at risk
Fatigue	General disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected52 at risk EG00113 affected105 at risk
Feeling jittery	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Influenza like illness	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0017 affected105 at risk
Injection site discolouration	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG00119 affected105 at risk
Injection site discomfort	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Injection site dryness	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Injection site erythema	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG00156 affected105 at risk
Injection site exfoliation	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Injection site haematoma	General disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG00117 affected105 at risk
Injection site haemorrhage	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0016 affected105 at risk
Injection site induration	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0015 affected105 at risk
Injection site inflammation	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Injection site nodule	General disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected52 at risk EG00113 affected105 at risk
Injection site oedema	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0016 affected105 at risk
Injection site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG00011 affected52 at risk EG00157 affected105 at risk
Injection site pallor	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Injection site papule	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Injection site pruritus	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG00131 affected105 at risk
Injection site rash	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0016 affected105 at risk
Injection site reaction	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0015 affected105 at risk
Injection site recall reaction	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Injection site swelling	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG00117 affected105 at risk
Injection site urticaria	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0013 affected105 at risk
Injection site vesicles	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0015 affected105 at risk
Injection site warmth	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0019 affected105 at risk
Malaise	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Oedema	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Oedema peripheral	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0013 affected105 at risk
Pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0016 affected105 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG0015 affected105 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG0010 affected105 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG00111 affected105 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Seasonal allergy	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0014 affected105 at risk
Acarodermatitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0012 affected105 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Conjunctivitis viral	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Fungal infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Influenza	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0016 affected105 at risk
Labyrinthitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Laryngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0016 affected105 at risk
Oral herpes	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Otitis externa	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Otitis media	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Rhinitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG0014 affected105 at risk
Tinea pedis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Tooth abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Tooth infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0006 affected52 at risk EG00110 affected105 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 affected52 at risk EG00112 affected105 at risk
Viral infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0011 affected105 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Alanine aminotransferase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0019 affected105 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0015 affected105 at risk
Beta 2 microglobulin urine increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Blood creatinine increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Blood glucose increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Blood testosterone decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Blood urea increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Body temperature increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
C-reactive protein increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Eosinophil percentage increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Haematocrit decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Haemoglobin decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Heart rate irregular	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Helicobacter test positive	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hepatic enzyme increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0014 affected105 at risk
International normalised ratio increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Liver function test abnormal	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0018 affected105 at risk
Platelet count decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Protein urine present	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Prothrombin time prolonged	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
QRS axis abnormal	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Red blood cell count decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Red blood cells urine positive	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
White blood cell count decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Gout	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0012 affected105 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0012 affected105 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0013 affected105 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0011 affected105 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0015 affected105 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected52 at risk EG0017 affected105 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0019 affected105 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Angiomyolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0015 affected105 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG00110 affected105 at risk
Hyporeflexia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Lethargy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Mental impairment	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Presyncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Sinus headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Somnolence	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Syncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Tremor	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Anxiety	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0013 affected105 at risk
Claustrophobia	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0013 affected105 at risk
Disorientation	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Dysphoria	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Insomnia	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0015 affected105 at risk
Libido decreased	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Listless	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Azotaemia	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Dysuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Nocturia	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Renal cyst	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0013 affected105 at risk
Endometrial atrophy	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Genital lesion	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Premenstrual syndrome	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0013 affected105 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0012 affected105 at risk
Nasal turbinate abnormality	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0013 affected105 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected52 at risk EG0010 affected105 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected52 at risk EG0016 affected105 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0012 affected105 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Aortic aneurysm	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Aortic stenosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Hot flush	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected52 at risk EG00111 affected105 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0012 affected105 at risk
Intermittent claudication	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk

ID	Term
D006937	Hypercholesterolemia
D003327	Coronary Disease

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Title	Description
BG000	Placebo	Participants received placebo subcutaneous injection once a week for 26 weeks.
BG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
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	Participants received placebo subcutaneous injection once a week for 26 weeks.			4	52	42	52
EG001	Mipomersen	Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.			7	105	97	105

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Angina unstable	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0011 affected105 at risk
Electrocardiogram abnormal	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected52 at risk EG0010 affected105 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected52 at risk EG0011 affected105 at risk