A Single Arm Trial With Resolute Onyx in ONE-Month DAPT f... | NCT03647475

Label	Type	Description	Intervention Names
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Experimental	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.	Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

Name	Type	Description	Arm Group Labels	Other Names
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT	Combination Product	To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Measure	Description	Time Frame
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction	Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year]	One Month to one year

Measure	Description	Time Frame
Number of Participants With Target Lesion Failure	Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical method	One Month to One Year
Number of Participants With Procedure Success

Name	Affiliation	Role
David Kandzari, MD	Piedmont Atlanta Hospital, Atlanta, GA	Principal Investigator
Ajay Kirtane, MD	New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Saint Joseph's Hospital Health Center		East Syracuse	New York	13057	United States
New York- Presbyterian Hospital/Columbia University Medical Center

PubMed Identifier	Type	Citation	Retractions
33167705	Background	Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.
39132335

ID	Title	Description
FG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 11, 2019	Feb 8, 2021

ID	Title	Description
BG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants	BG0001506

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

Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction

Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year]

The analysis population combines eligible subjects enrolled in the Onyx ONE US & Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear.

Posted

Count of Participants

Participants

One Month to one year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants	OG0001506

Title

Denominators

Categories

Title	Measurements
	OG000104

Secondary

Number of Participants With Target Lesion Failure

Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical method

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Participants With Procedure Success

Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.

Posted

Count of Participants

Participants

Procedure to hospital discharge, an average of 1.3 days

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

All Participants Deaths Including Cardiac Death

All participants deaths including cardiac death

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Patients With Major Cardiac Event

Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Patients With Myocardial Infarction

All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Patients With Target Vessel Failure

Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Patients With Revascularization

All revascularizations (TLR, TVR and non-TVR)

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Patients With Stent Thrombosis

Stent thrombosis (per Academic Research Consortium (ARC) definition)

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Number of Patients With Bleeding

Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe.

Grouping of BARC categories:

BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories
BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories
All BARC- This included all bleeding events BARC 1 through BARC 5

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Secondary

Number of Patients With Stroke

Stroke

Posted

Count of Participants

Participants

One Month to One Year

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants	OG000

Secondary

Lesion Success

The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method

Posted

Number

Lesions

End of Procedure, an average of 42 minutes

Lesions

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Secondary

Device Success

Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.

Posted

Number

Lesions

End of Procedure an average of 42 minutes

Lesions

ID	Title	Description
OG000	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00038 events34 affected1,506 at risk
Anaemia Macrocytic	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Microcytic Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Normocytic Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected1,506 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00040 events38 affected1,506 at risk
Angina Pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00026 events26 affected1,506 at risk
Angina Unstable	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00016 events16 affected1,506 at risk
Anginal Equivalent	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00059 events48 affected1,506 at risk
Atrial Flutter	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected1,506 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Bradycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected1,506 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bundle Branch Block Right	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Cardiac Asthma	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00022 events21 affected1,506 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected1,506 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00052 events40 affected1,506 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Chronic Left Ventricular Failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Conduction Disorder	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00015 events14 affected1,506 at risk
Coronary Artery Dissection	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Coronary Artery Occlusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Coronary Artery Thrombosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Coronary Ostial Stenosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Dressler's Syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Microvascular Coronary Artery Disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mitral Valve Disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Myocardial Haemorrhage	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00012 events12 affected1,506 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Palpitations	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Prosthetic Cardiac Valve Thrombosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pulseless Electrical Activity	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Sinus Node Dysfunction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Gastrointestinal Arteriovenous Malformation	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Haemorrhagic Arteriovenous Malformation	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hypertrophic Cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Deafness	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Vestibular Disorder	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blindness Unilateral	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected1,506 at risk
Diabetic Retinopathy	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Eye Ulcer	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Macular Degeneration	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Retinal Artery Occlusion	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Retinal Haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected1,506 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chronic Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Diverticulum Intestinal Haemorrhagic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected1,506 at risk
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Erosive Duodenitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Femoral Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastric Perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastrointestinal Erosion	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00012 events12 affected1,506 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemorrhagic Ascites	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ileus	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Incarcerated Inguinal Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Intra-Abdominal Haematoma	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Levator Syndrome	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 events5 affected1,506 at risk
Melaena	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mesenteric Artery Stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pharyngo-Oesophageal Diverticulum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tooth Impacted	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Umbilical Hernia, Obstructive	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Varices Oesophageal	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Adverse Drug Reaction	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Catheter Site Haemorrhage	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Chest Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00018 events17 affected1,506 at risk
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG00015 events15 affected1,506 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
General Physical Health Deterioration	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Generalised Oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Impaired Healing	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Implant Site Haemorrhage	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Incarcerated Hernia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Infusion Site Extravasation	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Injection Site Extravasation	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00019 events18 affected1,506 at risk
Oedema Peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Peripheral Swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Physical Deconditioning	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Sudden Cardiac Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Sudden Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Vascular Stent Stenosis	General disorders	MedDRA 23.0	Systematic Assessment	EG00022 events22 affected1,506 at risk
Vascular Stent Thrombosis	General disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Autoimmune Hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cirrhosis Alcoholic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatic Mass	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatitis Acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Non-Alcoholic Steatohepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Food Allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Primary Amyloidosis	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abdominal Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abscess Jaw	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abscess Limb	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arthritis Bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bacterial Parotitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Bronchitis Viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Carbuncle	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected1,506 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cystitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cytomegalovirus Oesophagitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dengue Fever	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Related Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Device Related Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diabetic Foot Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diverticulitis Intestinal Haemorrhagic	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Endocarditis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Endocarditis Bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Endocarditis Enterococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Enterococcal Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Enterocolitis Fungal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected1,506 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Herpes Zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hordeolum	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Infected Seroma	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Infective Exacerbation Of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Nosocomial Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Osteomyelitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Parainfluenzae Virus Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00048 events43 affected1,506 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Pneumonia Klebsiella	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pulmonary Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Cyst Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected1,506 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00016 events15 affected1,506 at risk
Septic Shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Streptococcal Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00023 events20 affected1,506 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Urosepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Wound Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Allergic Transfusion Reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Anaemia Postoperative	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arteriovenous Fistula Thrombosis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Procedure Complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Valve Replacement Complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chemical Peritonitis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Costal Cartilage Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected1,506 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Flail Chest	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemodialysis Complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Incision Site Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Peripheral Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Post Procedural Bile Leak	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Postoperative Hypotension	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Postoperative Ileus	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Postoperative Thoracic Procedure Complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Procedural Dizziness	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Pulmonary Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Traumatic Intracranial Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urinary Tract Stoma Complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vascular Access Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blood Glucose Fluctuation	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blood Pressure Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Output Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ejection Fraction Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Haemoglobin Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Heparin-Induced Thrombocytopenia Test Positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Oxygen Saturation Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pulmonary Function Test Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Stress Echocardiogram Abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Alcoholic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Diabetic Metabolic Decompensation	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Mineral Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chest Wall Haematoma	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Haematoma Muscle	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Spinal Instability	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Systemic Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Adenocarcinoma Of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atypical Fibroxanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected1,506 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Bone Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Brain Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected1,506 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastrointestinal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastrointestinal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatic Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hepatic Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypopharyngeal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lip And/Or Oral Cavity Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lung Carcinoma Cell Type Unspecified Stage Iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Metastatic Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Non-Hodgkin's Lymphoma Stage Iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Oesophageal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Oesophageal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Parathyroid Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Plasma Cell Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Prostate Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Altered State Of Consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Amputation Stump Pain	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Carotid Artery Occlusion	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00011 events10 affected1,506 at risk
Cerebrovascular Insufficiency	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dementia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Embolic Stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Frontotemporal Dementia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hemiparesis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0009 events3 affected1,506 at risk
Hypoxic-Ischaemic Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Metabolic Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Myelopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Presyncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Sciatica	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Stupor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00012 events11 affected1,506 at risk
Transient Global Amnesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Vertebrobasilar Stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Capturing Issue	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Deposit Issue	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Inappropriate Shock Delivery	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Loosening	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Malfunction	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lead Dislodgement	Product Issues	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Stent Malfunction	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Alcohol Withdrawal Syndrome	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected1,506 at risk
Delirium	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Dissociative Amnesia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hallucination, Visual	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mental Status Changes	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00034 events30 affected1,506 at risk
Azotaemia	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
End Stage Renal Disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0008 events6 affected1,506 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected1,506 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Nephropathy Toxic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Cyst Haemorrhage	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Renal Failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Renal Haematoma	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00011 events9 affected1,506 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00016 events13 affected1,506 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00017 events10 affected1,506 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mediastinal Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected1,506 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events3 affected1,506 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Respiratory Acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00014 events12 affected1,506 at risk
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Colostomy	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hernia Repair	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Prostatectomy	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Toe Operation	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Aortic Dissection	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Aortic Stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00012 events12 affected1,506 at risk
Arteriosclerosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bleeding Varicose Vein	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Dry Gangrene	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected1,506 at risk
Embolism Venous	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Extremity Necrosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haematoma	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Haemodynamic Instability	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemorrhage	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00010 events9 affected1,506 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Hypertensive Urgency	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected1,506 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Intermittent Claudication	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Peripheral Artery Aneurysm	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Peripheral Artery Occlusion	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected1,506 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Steal Syndrome	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Thrombophlebitis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vena Cava Thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Anaemia Folate Deficiency	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemorrhagic Disorder	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Schistocytosis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Angina Pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00032 events29 affected1,506 at risk
Angina Unstable	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Anginal Equivalent	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00014 events14 affected1,506 at risk
Atrial Flutter	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Bradycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bundle Branch Block Right	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0009 events9 affected1,506 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cardiac Valve Disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Defect Conduction Intraventricular	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Intracardiac Thrombus	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Palpitations	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tricuspid Valve Incompetence	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Conjunctival Haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected1,506 at risk
Diplopia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Eye Haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Eye Pain	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lacrimation Increased	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Anal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Anal Stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Appendicolith	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Atrophic Glossitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected1,506 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected1,506 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dyschezia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected1,506 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Gingival Bleeding	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gingival Hypertrophy	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Melaena	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected1,506 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Tongue Disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tongue Haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected1,506 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Adverse Drug Reaction	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Catheter Site Haematoma	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Catheter Site Haemorrhage	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chest Discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0009 events9 affected1,506 at risk
Chest Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00028 events28 affected1,506 at risk
Drug Intolerance	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Exercise Tolerance Decreased	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected1,506 at risk
Hangover	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected1,506 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00022 events21 affected1,506 at risk
Oedema Peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Peripheral Swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Puncture Site Haematoma	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatic Lesion	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hepatic Steatosis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nonalcoholic Fatty Liver Disease	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Contrast Media Allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected1,506 at risk
Chronic Hepatitis C	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Cystitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ear Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Fungal Skin Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Furuncle	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Helicobacter Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Lung Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Necrotising Soft Tissue Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Oral Candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Orchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tonsillitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tooth Abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00010 events10 affected1,506 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vulvovaginal Candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Wound Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arteriovenous Graft Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00019 events16 affected1,506 at risk
Eye Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Incision Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Muscle Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Periorbital Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Plaque Shift	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected1,506 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Post Procedural Haematuria	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Postoperative Hypertension	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Skin Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00010 events10 affected1,506 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vascular Access Site Bruising	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vascular Access Site Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Vascular Access Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Vascular Access Site Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Wound Haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Aortic Bruit	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blood Creatinine Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Blood Pressure Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Haemoglobin Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
International Normalised Ratio Abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Liver Function Test Abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nutritional Condition Normal	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Occult Blood	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Occult Blood Positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Troponin Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Venous Pressure Jugular Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vitamin B12 Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Calcium Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected1,506 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Chondrocalcinosis Pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Mobility Decreased	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected1,506 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Neck Mass	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected1,506 at risk
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Polymyalgia Rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Sarcopenia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Sjogren's Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Myolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Squamous Cell Carcinoma Of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Akinesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Amnesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Balance Disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cognitive Disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Corticobasal Degeneration	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected1,506 at risk
Focal Dyscognitive Seizures	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected1,506 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypotonia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Migraine	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Polyneuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Sciatica	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Tension Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Tonic Convulsion	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Visual Field Defect	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Device Malfunction	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Confusional State	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Delirium	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Psychotic Disorder Due To A General Medical Condition	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Bladder Dilatation	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Calculus Bladder	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00022 events21 affected1,506 at risk
Nocturia	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Renal Mass	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Urethral Haemorrhage	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urethral Perforation	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urinary Bladder Haemorrhage	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Urogenital Haemorrhage	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Adnexa Uteri Mass	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Postmenopausal Haemorrhage	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected1,506 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00017 events14 affected1,506 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00023 events20 affected1,506 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nasal Crusting	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nocturnal Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected1,506 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Nail Bed Bleeding	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Ulcer Haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Spider Naevus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Cerumen Removal	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Skin Neoplasm Excision	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Aortic Stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Extremity Necrosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Haematoma	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected1,506 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00012 events10 affected1,506 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected1,506 at risk
Intermittent Claudication	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Jugular Vein Thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Labile Blood Pressure	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected1,506 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected1,506 at risk
Subclavian Vein Thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Varicose Vein Ruptured	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Venous Stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk
Venous Thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected1,506 at risk

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