CRESTOR Athero Imaging Head to Head IVUS Study | NCT00620542

ID	Type	Description	Link
2007-004000-13

Name	Class
The Cleveland Clinic	OTHER

Label	Type	Description	Intervention Names
Rosuvastatin 20 mg	Experimental	Rosuvastatin 20 mg distributed in 2-week run-in period	Drug: Rosuvastatin
Atorvastatin 40 mg	Active Comparator	Atorvastatin 40 mg distributed in 2-week run-in period	Drug: Atorvastatin
Rosuvastatin 40 mg	Experimental	Rosuvastatin 40 mg distributed in core 2-year study	Drug: Rosuvastatin
Atorvastatin 80 mg	Active Comparator	Atorvastatin 80 mg distributed in core 2-year study	Drug: Atorvastatin

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	capsule, oral, once daily	Rosuvastatin 20 mg Rosuvastatin 40 mg

Measure	Description	Time Frame
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)	Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: [sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.	End of study (Week 104)

Measure	Description	Time Frame
Numbers of Patients Showing Regression in PAV	Regression defined as a change from baseline in PAV < 0	End of study (Week 104)
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)

Name	Affiliation	Role
Stephen J Nicholls, MBBS, PhD	Cleveland Clinic Foundation, Cardiovascular Medicine	Principal Investigator

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

PubMed Identifier	Type	Citation	Retractions
25240453	Derived	Puri R, Nissen SE, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Libby P, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. Sex-related differences of coronary atherosclerosis regression following maximally intensive statin therapy: insights from SATURN. JACC Cardiovasc Imaging. 2014 Oct;7(10):1013-22. doi: 10.1016/j.jcmg.2014.04.019. Epub 2014 Sep 17.
24448227

ID	Title	Description
FG000	Rosuvastatin 20 mg	2 week run-in period
FG001	Atorvastatin 40 mg	2 week run-in period

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)

Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:

[sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Median

95% Confidence Interval

Percent change

End of study (Week 104)

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000520 OG001519

Title

Denominators

Categories

Title	Measurements
	OG000-1.22(-1.52 to -0.90) OG001-0.99(-1.19 to -0.63)

Secondary

Numbers of Patients Showing Regression in PAV

Regression defined as a change from baseline in PAV < 0

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Number

Participants

End of study (Week 104)

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)

Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Median

95% Confidence Interval

mm^3

End of study (Week 104)

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Numbers of Patients Showing Regression in TAV

Regression defined as a change from baseline in TAV < 0

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Number

Participants

End of study (Week 104)

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Total Cholesterol Blood Level

Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

LDL-C Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

HDL-C Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Triglycerides Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Non-HDL-C Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

LDL-C/HDL-C Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

Ratio

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Total Cholesterol/HDL-C Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

Ratio

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Non-HDL-C/HDL-C Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

Ratio

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Apolipoprotein B Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Apolipoprotein A-1 Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

Apoliprotein B/Apolipoprotein A-1 Blood Level

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

Ratio

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Secondary

VLDL-C During the 104 Week Treatment Period

Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

Posted

Least Squares Mean

Standard Error

mg/dL

104 weeks

ID	Title	Description
OG000	Rosuvastatin 40 mg	Part B: Rosuvastatin 40 mg for core study - 2 years
OG001	Atorvastatin 80 mg	Part B: Atorvastatin 80 mg for core study - 2 years

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG0032 affected689 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected783 at risk EG0015 affected795 at risk EG00225 affected691 at risk EG003
Angina Unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0012 affected795 at risk EG00217 affected691 at risk EG003
Coronary Artery Stenosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG00212 affected691 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG00210 affected691 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0025 affected691 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0023 affected691 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0025 affected691 at risk EG003
Mitral Valve Incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Palpitations	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Acute Coronary Syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0012 affected795 at risk EG0021 affected691 at risk EG003
Myocardial Ischaemia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Sick Sinus Syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Atrial Flutter	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Cardiac Failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Coronary Artery Insufficiency	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Coronary Artery Occlusion	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Coronary Artery Thrombosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Pericardial Rub	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Sinus Arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Wolff-Parkinson-White Syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Congenital Coronary Artery Malformation	Congenital, familial and genetic disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Hip Dysplasia	Congenital, familial and genetic disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Vertigo Positional	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Basedow's Disease	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Cataract	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Retinal Detachment	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0024 affected691 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Colitis Ulcerative	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Colonic Polyp	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Erosive Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Gastric Polyps	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Gastric Ulcer	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Retroperitoneal Haematoma	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0021 affected691 at risk EG003
Retroperitoneal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Umbilical Hernia, Obstructive	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0013 affected795 at risk EG00214 affected691 at risk EG003
Chest Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0027 affected691 at risk EG003
Chest Discomfort	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Device Malfunction	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Device Occlusion	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Device Stimulation Issue	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Hernia Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Sudden Death	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Thrombosis In Device	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0024 affected691 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0024 affected691 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Urosepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Appendicitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Appendicitis Perforated	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Arthritis Bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Dengue Fever	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Groin Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Herpes Zoster Infection Neurological	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Pilonidal Cyst	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Puncture Site Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Staphylococcal Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
In-Stent Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0026 affected691 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Fractured Coccyx	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Head Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Heat Exhaustion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
In-Stent Arterial Restenosis	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Intentional Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Post Procedural Myocardial Infarction	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Traumatic Lung Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Blood Pressure Increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Cardiac Stress Test Abnormal	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Heart Rate Irregular	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Occult Blood Positive	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Transaminases Increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0026 affected691 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0024 affected691 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Bone Loss	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Floating Patella	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Eyelid Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Gallbladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Neoplasm Prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Throat Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Presyncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Carotid Artery Stenosis	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Ischaemic Stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0022 affected691 at risk EG003
Cerebral Haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Complicated Migraine	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Grand Mal Convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Haemorrhage Intracranial	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Haemorrhagic Stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Intracranial Hypotension	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Tremor	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Confusional State	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Dependence	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Panic Attack	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Suicidal Ideation	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Bladder Neck Obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Calculus Bladder	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Ureteric Stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0023 affected691 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Nasal Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Nasal Polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0020 affected691 at risk EG003
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Coronary Arterial Stent Insertion	Surgical and medical procedures	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Intermittent Claudication	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Subclavian Artery Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0022 affected691 at risk EG003
Aortic Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Arterial Occlusive Disease	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Arterial Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0011 affected795 at risk EG0021 affected691 at risk EG003
Femoral Arterial Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Haematoma	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0021 affected691 at risk EG003
Iliac Artery Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Peripheral Ischaemia	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003
Thrombophlebitis Superficial	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected783 at risk EG0010 affected795 at risk EG0020 affected691 at risk EG003

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011758	Pyrroles
D001393	Azoles
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids

ID	Title	Description
BG000	Rosuvastatin 40 mg	2 years
BG001	Atorvastatin 80 mg	2 years
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rosuvastatin 20 mg	2 week run-in period	21	783	0	783
EG001	Atorvastatin 40 mg	2 week run-in period	25	795	0	795
EG002	Rosuvastatin 40 mg	2 year core study	194	691	210	691
EG003	Atorvastatin 80 mg	2 year core study	168	689	213	689