Effect of RVX000222 on Time to Major Adverse Cardiovascul... | NCT02586155

Name	Class
PPD Development, LP	INDUSTRY
ICON plc	INDUSTRY
Medidata Solutions	INDUSTRY

Label	Type	Description	Intervention Names
High-Intensity statin therapy+RVX000222	Experimental	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)	Drug: Apabetalone Drug: Atorvastatin Drug: Rosuvastatin
High-Intensity statin therapy+Placebo	Active Comparator	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)	Drug: Placebo Drug: Atorvastatin Drug: Rosuvastatin

Name	Type	Description	Arm Group Labels	Other Names
Apabetalone	Drug	100 mg capsule	High-Intensity statin therapy+RVX000222

Measure	Description	Time Frame
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.	120 weeks

Measure	Description	Time Frame
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	First occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• ACS event of either unstable angina or myocardial infarction 7-90 days prior Visit 1:

Unstable angina: for a qualifying unstable angina event, each of components (a), (b), and (c) must be satisfied: a.) Characteristic ischemic pain or discomfort in chest/associated referral areas, occurring at rest/with minimal exertion b.) ECG changes consistent with acute myocardial ischemia based on new/presumed ST elevation/depression or T-wave inversion c.) Objective evidence of obstructive CAD based on 1+ of the following: i. New/presumed new evidence of myocardial ischemia/infarction by perfusion imaging ii. New/presumed new regional wall motion abnormality iii. Current evidence of at least 1 epicardial coronary artery stenosis ≥70% by coronary angiography iv. Need for coronary revascularization for the index ACS event, including a percutaneous coronary intervention (PCI) with or without coronary stenting.

Prior MI 7-90 days prior screening treated with or without a percutaneous coronary intervention (PCI). For a qualifying event of MI 2 of the following 3 criteria must be satisfied: a.) Characteristic ischemic chest pain/pain in associated referral areas b.) Dynamic elevation of troponin T/I or CKMB if troponinT/I is unavailable at local lab (at least >ULN for lab) c.) Development of new Q-waves in ≥2 adjacent ECG leads or development of new dominant R wave in V1

Documented diagnosis of T2DM (1+ of the following criteria): Documented history of T2DM, History of taking diabetes medication, and/or HbA1c ≥6.5% at Visit 1
For males HDL-C<40 mg/dL(1.04 mmol/L), for females HDL-C<45 mg/dL(1.17 mmol/L) at Visit 1
Subjects currently not on high intensity statin therapy could start rosuvastatin at Visit 1 and those currently on therapy besides atorvastatin/rosuvastatin can be switched to rosuvastatin at Visit 1
Female subjects of non-childbearing potential (post-surgical sterilization/post-menopausal) or if childbearing potential have neg urine pregnancy test and be willing and able to use non-hormonal birth control (non-hormonal IUD, condom or diaphragm) or remain abstinent from Screening to Follow-up Visit
Give signed informed consent

Exclusion Criteria:

Heart disease which will w/in 90 days of Visit 1 likely need coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement
Previous/current diagnosis of severe heart failure or documented LVEF<25% determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. Absence of LVEF measurement in subject w/out a previous/current diagnosis of heart failure does not exclude entry into study
Evidence of cardiac EP instability incl. history of uncontrolled ventricular arrhythmias, atrial fibrillation/flutter or supraventricular tachycardias w/ a ventricular response HR>100bpm at rest w/in 4 wks prior Visit 1
CABG w/in 90 days prior Visit 1
Evidence of severe renal impairment as determined by either eGFR<30 mL/min/1.7m2 at Visit 1 or current need for dialysis
Uncontrolled hypertension defined as 2 consecutive measurements of sitting BP of systolic>180 mmHg or diastolic>100 mmHg at Visit 1
Treatment w/ immunosuppressants w/in 12 mos prior Visit 1
Use of fibrates at any dose or niacin/nicotinic acid 250+ mg w/in 30 days prior Visit 1
Known allergy/sensitivity to any ingredient in IMP
History of intolerance to atorvastatin/rosuvastatin
Triglycerides>400 mg/dL (4.52 mmol/L) at Visit 1
Any medical/surgical condition which might significantly alter absorption, distribution, metabolism or excretion of medication
Evidence of cirrhosis from liver imaging/biopsy, history of hepatic encephalopathy, esophageal/gastric varices, active hepatitis or prior porta-caval shunt procedure or a Child-Pugh score of ≥5 points
ALT/AST>1.5xULN by central lab at Visit 1
Tot. bilirubin>ULN by central lab at Visit 1
History of malignancy of any organ syst treated/untreated w/in the past 2 yrs whether or not there is evidence of local recurrence/metastases except localized basal skin cell carcinoma
History/evidence of drug/alcohol abuse w/in 12 mos of Visit 1
Pregnancy
Any condition which may place subject at higher risk from his/her participation in the study or is likely to prevent subject from completing/complying w/ requirements of study
Use of other investigational drugs and devices w/in 30 days or 5 half-lives of Visit 1, whichever is longer
History of noncompliance to medical regimens or unwillingness to comply w/ study protocol
Any condition that would confound the evaluation/interpretation of efficacy and/or safety data
Persons directly involved in execution of this protocol

Name	Affiliation	Role
Kausik Ray, MD	Imperial College London	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Investigaciones Clinicas Bahia Blanca		Bahía Blanca			Argentina
Bioclinica Buenos Aires

PubMed Identifier	Type	Citation	Retractions
32219359	Result	Ray KK, Nicholls SJ, Buhr KA, Ginsberg HN, Johansson JO, Kalantar-Zadeh K, Kulikowski E, Toth PP, Wong N, Sweeney M, Schwartz GG; BETonMACE Investigators and Committees. Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Apr 28;323(16):1565-1573. doi: 10.1001/jama.2020.3308.
34158057

ID	Title	Description
FG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
FG001	High-Intensity Statin Therapy+Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 31, 2017	Jun 21, 2021

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

Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE

Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.

Posted

Number

events

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG0001212 OG0011206

Title

Denominators

Categories

CV Death

Title	Measurements
	OG00034 OG00142

Non-fatal MI

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified long-rank		0.1070		Cox Proportional Hazard	0.823			2-Sided	95	0.649	1.044					Superiority

Secondary

Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE

First occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted.

Posted

Number

events

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Secondary

Incidence of Hospitalization for Congestive Heart Failure (CHF)

Posted

Number

events

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Incidence of All-cause Mortality

Posted

Count of Participants

Participants

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups

A select subset of subjects were analyzed for ApoA-I, Subject data is missing across time points.

Posted

Median

Inter-Quartile Range

mg/dL

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups

A select subset of subjects were analyzed for ApoB, Subject data is missing across time points.

Posted

Median

Inter-Quartile Range

mg/dL

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups

All subjects were analyzed and contributed LDL-C data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.

Subject data is missing across time points.

Posted

Median

Inter-Quartile Range

mmol/L

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups

All subjects were analyzed and contributed HDL-C data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.

Subject data is missing across time points.

Posted

Median

Inter-Quartile Range

mmol/L

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups

All subjects were analyzed and contributed TG data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.

Subject data is missing across time points.

Posted

Median

Inter-Quartile Range

mmol/L

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups

All subjects were analyzed and contributed HbA1c data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms Subject data is missing across time points

Posted

Median

Inter-Quartile Range

% of hemoglobin

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Glucose From Baseline Over Time Between and Within Treatment Groups

All subjects were analyzed and contributed glucose data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.

Subject data is missing across time points

Posted

Median

Inter-Quartile Range

mmol/L

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups

Subject data is missing across time points

Posted

Median

Inter-Quartile Range

U/L

172 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups

A select subset of subjects in two countries were analyzed for CRP, Subject data is missing across time points.

Posted

Median

Inter-Quartile Range

mg/dL

52 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Secondary

Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)

Subject data is missing across time points

Posted

Median

Inter-Quartile Range

ml/min

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Post-Hoc

Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE

First occurrence of four-point MACE defined as a single composite endpoint of cardiovascular (CV) death (including undetermined cause of death) or non-fatal myocardial infarction (MI), stroke or hospital admission for congestive heart failure.

Posted

Number

events

120 weeks

ID	Title	Description
OG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
OG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00057 affected1,212 at risk EG00139 affected1,207 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00042 affected1,212 at risk EG00149 affected1,207 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00032 affected1,212 at risk EG00132 affected1,207 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected1,212 at risk EG00128 affected1,207 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00014 affected1,212 at risk EG00111 affected1,207 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected1,212 at risk EG00110 affected1,207 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected1,212 at risk EG0019 affected1,207 at risk
Coronary artery disease	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected1,212 at risk EG0016 affected1,207 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected1,212 at risk EG0019 affected1,207 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected1,212 at risk EG0016 affected1,207 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected1,212 at risk EG0014 affected1,207 at risk
Myocardial ischemia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected1,212 at risk EG0013 affected1,207 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0015 affected1,207 at risk
Cardiac arrest	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0015 affected1,207 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0014 affected1,207 at risk
Atrial flutter	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0011 affected1,207 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0011 affected1,207 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0013 affected1,207 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0013 affected1,207 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Left ventricular failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Anginal equivalent	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Arrhythmia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Atrioventricular block	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cardiac discomfort	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pericardial effusion	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Pericarditis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Ventricular failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00015 affected1,212 at risk EG00117 affected1,207 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0006 affected1,212 at risk EG0013 affected1,207 at risk
Cellulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0013 affected1,207 at risk
Bronchitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0014 affected1,207 at risk
Osteomyelitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0012 affected1,207 at risk
Gangrene	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0011 affected1,207 at risk
Sepsis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Septic shock	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0011 affected1,207 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Viral infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0011 affected1,207 at risk
Diverticulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Ertsipelas	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Urosepsis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Diabetic gangrene	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Postoperative wound infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Pyelonephritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Acute endocarditis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Anal abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Appendicitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Appendicitis perforated	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Brain abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Cholecystitis infective	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cystitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Device related infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Diabetic foot infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Gallbladder empyema	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Hepatitis E	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Hepatitis viral	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Herpes zoster	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Localised infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Lung infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Mastoiditis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Mediastinitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Necrotising fasciitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Opportunistic infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Pneumonia legionella	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Pneumonia necrotising	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Scrotal abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Soft tissue infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Tooth abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected1,212 at risk EG0015 affected1,207 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected1,212 at risk EG0012 affected1,207 at risk
Syncope	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0015 affected1,207 at risk
Transient ischaemic attack	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0013 affected1,207 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Cerebral infarction	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Quadriparesis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Brain stem stroke	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cervical cord compression	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Dizziness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Dysarthria	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Febrile convulsion	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Nerve compression	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Paraesthesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Parkinson's disease	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Polyneuropathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Seizure	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00033 affected1,212 at risk EG00125 affected1,207 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected1,212 at risk EG0011 affected1,207 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0011 affected1,207 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Gastritis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Gastrointestinal angiodysplasia haemorrhagic	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Ileus	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected1,212 at risk EG0017 affected1,207 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0019 affected1,207 at risk
Hypertensive crisis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0017 affected1,207 at risk
Hypertensive emergency	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Aortic stenosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Hypotension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Arteriosclerosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Extremity necrosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Haematoma	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Ischaemia	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Subclavian artery occlusion	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0013 affected1,207 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Benign hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Ovarian cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Uterine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected1,212 at risk EG00112 affected1,207 at risk
Sudden death	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0016 affected1,207 at risk
Death	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0013 affected1,207 at risk
Sudden cardiac death	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0013 affected1,207 at risk
Pyrexia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Vascular stent restenosis	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Exercise tolerance decreased	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Oedema peripheral	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Vascular stent occlusion	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Vascular stent stenosis	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Vascular stent thrombosis	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected1,212 at risk EG0017 affected1,207 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected1,212 at risk EG0013 affected1,207 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Renal failure	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Urinary retention	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Azotaemia	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Bladder perforation	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Calculus bladder	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Nephropathy	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Renal mass	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Ureteric rupture	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected1,212 at risk EG0019 affected1,207 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0013 affected1,207 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected1,212 at risk EG0015 affected1,207 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected1,212 at risk EG0011 affected1,207 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0013 affected1,207 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Paranasal sinus haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Vocal cord cyst	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Lumbosacral plexus injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Nerve root injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Postpericardiotomy syndrome	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Radial head dislocation	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected1,212 at risk EG0015 affected1,207 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0012 affected1,207 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0012 affected1,207 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Gout	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0015 affected1,207 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Cataract	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Glaucoma	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0013 affected1,207 at risk
Diabetic retinopathy	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Detachment of retinal pigment epithelium	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Eye haemorrhage	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Hypotony of eye	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Iris bombe	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Posterior capsule opacification	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Retinal detachment	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected1,212 at risk EG0011 affected1,207 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0003 affected1,212 at risk EG0010 affected1,207 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0010 affected1,207 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Blood pressure abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Depression	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0011 affected1,207 at risk
Anxiety	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Completed suicide	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Confusional state	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Suicide attempt	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0012 affected1,207 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected1,212 at risk EG0011 affected1,207 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected1,212 at risk EG0010 affected1,207 at risk
Amyloidosis	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk
Medical device removal	Surgical and medical procedures	MedDRA (18.1)	Systematic Assessment	EG0000 affected1,212 at risk EG0011 affected1,207 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003324	Coronary Artery Disease

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
C000628794	apabetalone
D000069059	Atorvastatin
D000068718	Rosuvastatin Calcium

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

ID	Title	Description
BG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
BG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	High-Intensity Statin Therapy+RVX000222	Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Apabetalone: 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin	61	1,212	354	1,212	830	1,212
EG001	High-Intensity Statin Therapy+Placebo	Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule Atorvastatin: High-Intensity Statin Rosuvastatin: High-Intensity Statin	72	1,207	339	1,207	820	1,207

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00046 affected1,212 at risk EG00156 affected1,207 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00058 affected1,212 at risk EG00140 affected1,207 at risk
Influenza	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00043 affected1,212 at risk EG00147 affected1,207 at risk
Bronchitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00025 affected1,212 at risk EG00132 affected1,207 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00027 affected1,212 at risk EG00126 affected1,207 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00029 affected1,212 at risk EG00124 affected1,207 at risk
Angina	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00074 affected1,212 at risk EG00176 affected1,207 at risk
Angina unstable	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00058 affected1,212 at risk EG00141 affected1,207 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00042 affected1,212 at risk EG00150 affected1,207 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00022 affected1,212 at risk EG00138 affected1,207 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00043 affected1,212 at risk EG00144 affected1,207 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00012 affected1,212 at risk EG00124 affected1,207 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00026 affected1,212 at risk EG0017 affected1,207 at risk
Hepatobiliary	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00024 affected1,212 at risk EG00142 affected1,207 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00037 affected1,212 at risk EG00133 affected1,207 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00027 affected1,212 at risk EG00128 affected1,207 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00015 affected1,212 at risk EG00126 affected1,207 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected1,212 at risk EG00124 affected1,207 at risk
Worsening diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG00093 affected1,212 at risk EG00193 affected1,207 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG00072 affected1,212 at risk EG00172 affected1,207 at risk
ALT increase	Investigations	MedDRA (18.1)	Systematic Assessment	EG00064 affected1,212 at risk EG00118 affected1,207 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG00033 affected1,212 at risk EG00139 affected1,207 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG00036 affected1,212 at risk EG00140 affected1,207 at risk