An Open-label Extension Study to Assess the Long-term Saf... | NCT00694109

ID	Type	Description	Link
2005-003450-10	EudraCT Number

Name	Class
Ionis Pharmaceuticals, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Mipomersen	Experimental	Mipomersen Sodium once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.	Drug: Mipomersen Sodium

Name	Type	Description	Arm Group Labels	Other Names
Mipomersen Sodium	Drug	Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.	Mipomersen

Measure	Description	Time Frame
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)	Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).	Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Percent Change From Baseline in Apolipoprotein B (Apo B)	Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).	Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Percent Change From Baseline in Total Cholesterol	Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).

Measure	Description	Time Frame
Percent Change From Baseline in Triglycerides	Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).

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

Facility	Status	City	State	ZIP	Country	Contacts
		Mission Viejo	California	92691	United States

PubMed Identifier	Type	Citation	Retractions
27578134	Derived	Duell PB, Santos RD, Kirwan BA, Witztum JL, Tsimikas S, Kastelein JJP. Long-term mipomersen treatment is associated with a reduction in cardiovascular events in patients with familial hypercholesterolemia. J Clin Lipidol. 2016 Jul-Aug;10(4):1011-1021. doi: 10.1016/j.jacl.2016.04.013. Epub 2016 May 9.
24366918	Derived

ID	Title	Description
FG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

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)

Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants	OG000141

Title

Denominators

Categories

week 26 (n = 130)

Title	Measurements
	OG000-28.5(-31.9 to -25.1)

week 52 (n = 111)

Title	Measurements
	OG000-27(-31.2 to -22.8)

week 76 (n = 66)

Primary

Percent Change From Baseline in Apolipoprotein B (Apo B)

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Primary

Percent Change From Baseline in Total Cholesterol

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Primary

Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Triglycerides

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Lipoprotein (a)

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in LDL Particles' Size (Total)

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in LDL Particles' Size (Large)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in LDL Particles' Size (Medium)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in LDL Particles' Size (Small)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in LDL Particles' Size (Very Small)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts

Secondary

Percent Change From Baseline in HDL Particles' Size (Large)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in HDL Particles' Size (Medium)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in HDL Particles' Size (Small)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts

Secondary

Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Secondary

Percent Change From Baseline in VLDL Particles' Size (Medium)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in VLDL Particles' Size (Small)

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts

Secondary

Change From Baseline in C-Reactive Protein

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Apolipoprotein A-1

Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.

Posted

Mean

95% Confidence Interval

percent change

Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

ID	Title	Description
OG000	Mipomersen	Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected141 at risk
Aortic valve disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bradycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Extrasystoles	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Palpitations	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Hypothyroidism	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Arcus lipoides	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Cataract	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Diplopia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dry eye	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Eye irritation	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Eye pain	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Eye swelling	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Eyelid cyst	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Halo vision	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ocular hyperaemia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Presbyopia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vision blurred	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Vitreous floaters	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected141 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected141 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bezoar	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Dental caries	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00021 affected141 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Flatulence	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Gingival recession	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lip blister	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00037 affected141 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Oesophageal dilatation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Retching	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Toothache	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00013 affected141 at risk
Vomiting projectile	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Asthenia	General disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Chest discomfort	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Chills	General disorders	MedDRA 17.0	Systematic Assessment	EG00027 affected141 at risk
Cyst	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Device breakage	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Device failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Discomfort	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Exercise tolerance decreased	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Facial pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG00038 affected141 at risk
Feeling cold	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Gait disturbance	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Influenza like illness	General disorders	MedDRA 17.0	Systematic Assessment	EG00070 affected141 at risk
Injection site atrophy	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Injection site bruising	General disorders	MedDRA 17.0	Systematic Assessment	EG00072 affected141 at risk
Injection site discolouration	General disorders	MedDRA 17.0	Systematic Assessment	EG00055 affected141 at risk
Injection site discomfort	General disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected141 at risk
Injection site eczema	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Injection site erythema	General disorders	MedDRA 17.0	Systematic Assessment	EG000117 affected141 at risk
Injection site exfoliation	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Injection site extravasation	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Injection site haematoma	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Injection site haemorrhage	General disorders	MedDRA 17.0	Systematic Assessment	EG00017 affected141 at risk
Injection site hypersensitivity	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Injection site hypertrophy	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Injection site hypoaesthesia	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Injection site induration	General disorders	MedDRA 17.0	Systematic Assessment	EG00031 affected141 at risk
Injection site inflammation	General disorders	MedDRA 17.0	Systematic Assessment	EG00012 affected141 at risk
Injection site lymphadenopathy	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Injection site macule	General disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Injection site mass	General disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected141 at risk
Injection site nodule	General disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Injection site oedema	General disorders	MedDRA 17.0	Systematic Assessment	EG00019 affected141 at risk
Injection site pain	General disorders	MedDRA 17.0	Systematic Assessment	EG000102 affected141 at risk
Injection site pallor	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Injection site papule	General disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected141 at risk
Injection site paraesthesia	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Injection site pruritus	General disorders	MedDRA 17.0	Systematic Assessment	EG00046 affected141 at risk
Injection site rash	General disorders	MedDRA 17.0	Systematic Assessment	EG00016 affected141 at risk
Injection site reaction	General disorders	MedDRA 17.0	Systematic Assessment	EG00012 affected141 at risk
Injection site recall reaction	General disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected141 at risk
Injection site swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG00031 affected141 at risk
Injection site urticaria	General disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected141 at risk
Injection site vesicles	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Injection site warmth	General disorders	MedDRA 17.0	Systematic Assessment	EG00019 affected141 at risk
Local swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Localised oedema	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Malaise	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Oedema peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected141 at risk
Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG00013 affected141 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG00025 affected141 at risk
Swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Temperature intolerance	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tenderness	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vaccination site pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vessel puncture site bruise	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Xerosis	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Biliary cyst	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hepatic fibrosis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG00017 affected141 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Hypersensitivity	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Seasonal allergy	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Serum sickness	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Abscess limb	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Acarodermatitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Acute sinusitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Anal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00010 affected141 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Conjunctivitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cystitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Diverticulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ear infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Eye infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Folliculitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Furuncle	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Genital herpes simplex	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Giardiasis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
H1N1 influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Herpes zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00017 affected141 at risk
Kidney infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Laryngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Localised infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00028 affected141 at risk
Onychomycosis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Oral herpes	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Otitis externa	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Otitis media acute	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Paronychia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Post procedural infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Rhinitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Sinobronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Sinusitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00020 affected141 at risk
Skin bacterial infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tinea cruris	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tinea versicolour	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tooth abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Tooth infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00027 affected141 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00023 affected141 at risk
Vaginal infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Viral infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Wound infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Wound sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Animal scratch	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Kidney contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0007 affected141 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0008 affected141 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Post procedural contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Repetitive strain injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Splenic haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG00026 affected141 at risk
Albumin urine present	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG00021 affected141 at risk
Beta 2 microglobulin urine increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Blood bicarbonate decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Blood creatinine increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Blood phosphorus decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Blood potassium increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Blood pressure increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Blood testosterone decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Blood uric acid increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Body temperature increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
C-reactive protein increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cardiac murmur	Investigations	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Carotid bruit	Investigations	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Electrocardiogram abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Haematocrit decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Haemoglobin decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Heart rate increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hepatic enzyme increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
International normalised ratio increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Liver function test abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Liver scan abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lymph node palpable	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lymphocyte count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Multiple gated acquisition scan abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Mycobacterium tuberculosis complex test positive	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Nuclear magnetic resonance imaging abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Peripheral pulse decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Platelet count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Protein urine present	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Prothrombin time prolonged	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Red blood cell acanthocytes present	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Red blood cell count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Red blood cell schistocytes present	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Red blood cells urine positive	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Scan myocardial perfusion abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Transaminases increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Urine analysis abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Weight decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Weight increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
White blood cell count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00019 affected141 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00024 affected141 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected141 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected141 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00033 affected141 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected141 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Soft tissue atrophy	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected141 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Burning sensation	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Cluster headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cognitive disorder	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected141 at risk
Dizziness postural	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Dysgeusia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00035 affected141 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected141 at risk
Lethargy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Loss of consciousness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Migraine	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Migraine with aura	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Morton's neuralgia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Nerve compression	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Neuralgia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Orthostatic intolerance	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Presyncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Sciatica	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Sinus headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Somnolence	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Tremor	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected141 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Abnormal sleep-related event	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Anxiety	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Confusional state	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected141 at risk
Insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected141 at risk
Libido decreased	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Panic attack	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Stress	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Albuminuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bladder discomfort	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dysuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Nephropathy	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Proteinuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pyuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Renal cyst	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Urge incontinence	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Menstruation delayed	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Vulvovaginal burning sensation	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected141 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00012 affected141 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00013 affected141 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected141 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Lipodystrophy acquired	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected141 at risk
Xanthelasma	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Xanthoma	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic aneurysm	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic calcification	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic dilatation	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Aortic stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Flushing	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Haematoma	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Hot flush	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected141 at risk
Hypertensive crisis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Infarction	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Intermittent claudication	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pallor	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Peripheral coldness	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Phlebitis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D006938	Hyperlipoproteinemia Type II
D006949	Hyperlipidemias
D008659	Metabolic Diseases
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D007232	Infant, Newborn, Diseases
D000013	Congenital Abnormalities
D006937	Hypercholesterolemia
D006951	Hyperlipoproteinemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D000090542	Homozygous Familial Hypercholesterolemia

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D009750	Nutritional and Metabolic Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Angina unstable	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected141 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Device malfunction	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected141 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Contrast media allergy	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Appendicitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Amnesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Arachnoid cyst	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Partial seizures	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected141 at risk
Alcoholism	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Ileostomy	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic aneurysm	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Aortic stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk
Peripheral artery dissection	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected141 at risk