IN.PACT™ AV Access IDE Study | NCT03041467

Label	Type	Description	Intervention Names
IN.PACT AV DCB	Experimental	PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."	Device: IN.PACT AV DCB
Standard Balloon Angioplasty	Active Comparator	PTA will be performed using a commercially available uncoated PTA balloon.	Device: Standard Balloon Angioplasty

Name	Type	Description	Arm Group Labels	Other Names
IN.PACT AV DCB	Device	IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon	IN.PACT AV DCB

Measure	Description	Time Frame
Target Lesion Primary Patency Rate Through 6 Months	Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.	6 Months Post-Procedure
Primary Safety Endpoint - Serious Adverse Event Rate	Serious Adverse Event (SAE) rate involving the AV access circuit	30 days post procedure

Measure	Description	Time Frame
Access Circuit Primary Patency	Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.	3, 6, 9, 12, 18, and 24 Months
Target Lesion Primary Patency

Name	Affiliation	Role
Robert Lookstein, MD	The Mount Sinai Hospital	Principal Investigator
Andrew Holden, MD	Auckland City Hospital	Principal Investigator
Hiroaki Haruguchi, MD	Haruguchi Vascular Access Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham (UAB) Hospital		Birmingham	Alabama	35233	United States
SKI Vascular Center

PubMed Identifier	Type	Citation	Retractions
41689689	Derived	Holden A, Haruguchi H, Suemitsu K, Isogai N, Hull J, Wiechmann BN, Wang H, Wall B, Lookstein R; IN.PACT AV Access Investigators. Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes. CVIR Endovasc. 2026 Feb 14;9(1):17. doi: 10.1186/s42155-026-00650-6.
32813949	Derived

ID	Title	Description
FG000	IN.PACT AV DCB	PTA will be performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
FG001	Standard Balloon Angioplasty

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 20, 2022	Aug 2, 2022

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

Target Lesion Primary Patency Rate Through 6 Months

Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.

Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.

Posted

Count of Participants

Participants

6 Months Post-Procedure

ID	Title	Description
OG000	IN.PACT AV DCB	PTA will be performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA will be performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000152 OG001148

Title

Denominators

Categories

Title	Measurements
	OG000125 OG00188

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		One-sided Z-test		<0.001														Superiority

Primary

Primary Safety Endpoint - Serious Adverse Event Rate

Serious Adverse Event (SAE) rate involving the AV access circuit

All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.

Posted

Count of Participants

Participants

30 days post procedure

ID	Title	Description
OG000	IN.PACT AV DCB	PTA will be performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA will be performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Access Circuit Primary Patency

Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.

There is no planned hypothesis test other than at 6 months time point.

Posted

Number

Percentage of participants

3, 6, 9, 12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Target Lesion Primary Patency

Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.

There is no planned hypothesis test other than at 6 months time-point.

Posted

Number

percentage of participants

3, 9, 12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Cumulative Target Lesion Revascularizations

The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.

Participants are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.

Posted

Count of Participants

Participants

3, 6, 9,12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Total Number of Interventions Required to Maintain Target Lesion Patency

The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.

Posted

Number

Total number of interventions

3, 6, 9, 12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Total Number of Interventions Required to Maintain Access Circuit Patency

The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.

Posted

Number

Total number of interventons

3, 6, 9, 12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Cumulative Access Circuit Thromboses

The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

Participant withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.

Posted

Count of Participants

Participants

3, 6, 9, 12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Device Success

Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.

Posted

Number

Devices successfully used

Time of Procedure

Devices used

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Procedure Success

Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).

Posted

Count of Participants

Participants

Time of Procedure

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Clinical Success

Resumption of successful dialysis for at least one session after index procedure.

Posted

Count of Participants

Participants

From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Rate of Device Related Adverse Events

Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

Number of Participants with One or More Device-Related Adverse Events

Posted

Count of Participants

Participants

30 days, 3, 6, 9, 12, 18, and 24 Months.

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Procedure Related Adverse Event Rate

Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

Number of Participants with One or More Procedure-Related Adverse Events

Posted

Count of Participants

Participants

30 Days, 3, 6, 9, 12, 18, and 24 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Target Lesion Revascularizations (TLR)

Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.

There is no planned hypothesis test.

Posted

Number

% of Cumulative Incidence Rate

6, 9, 12, 18, 24, and 36 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Clinically-Driven Target Lesion Revascularizations (CD-TLR)

Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure

There is no planned hypothesis test for this endpoint.

Posted

Number

Percentage of participants

6, 9, 12, 18, 24, and 36 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Re-interventions in the Access Circuit

Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.

There is no planned hypothesis test for this endpoint.

Posted

Number

Percentage of participants

6, 9, 12, 18, 24, and 36 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Abandonment of Target AVF

Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure.

Posted

Count of Participants

Participants

6, 9, 12, 18, 24, and 36 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Serious Adverse Event Rate

Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.

Posted

Count of Participants

Participants

6, 12, 24, and 36 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Secondary

Rate of Freedom From All-Cause Mortality Post Vital Status Update

Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.

Posted

Number

% of Survival

6, 12, 24, 36, 48, and 60 Months

ID	Title	Description
OG000	IN.PACT AV DCB	PTA was performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
OG001	Standard Balloon Angioplasty	PTA was performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected170 at risk EG0015 events3 affected160 at risk
Anaemia Of Chronic Disease	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected160 at risk
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0005 events3 affected170 at risk EG0010 events0 affected160 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0016 events6 affected160 at risk
Angina Pectoris	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0009 events6 affected170 at risk EG0016 events6 affected160 at risk
Angina Unstable	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Aortic Valve Incompetence	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events2 affected160 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected170 at risk EG0016 events5 affected160 at risk
Atrial Flutter	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected170 at risk EG0011 events1 affected160 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Bradycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected170 at risk EG0011 events1 affected160 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected170 at risk EG0017 events6 affected160 at risk
Cardiac Failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected170 at risk EG0012 events1 affected160 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0012 events2 affected160 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0009 events8 affected170 at risk EG00114 events12 affected160 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events1 affected160 at risk
Chronic Left Ventricular Failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected170 at risk EG0012 events2 affected160 at risk
Coronary Artery Occlusion	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected170 at risk EG0013 events3 affected160 at risk
Diastolic Dysfunction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0013 events3 affected160 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0011 events1 affected160 at risk
Pulseless Electrical Activity	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Acetylcholinesterase Deficiency	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Deafness Neurosensory	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hyperparathyroidism Secondary	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Cataract	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0006 events4 affected170 at risk EG0014 events4 affected160 at risk
Glaucoma	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Ascites	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected170 at risk EG0011 events1 affected160 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected170 at risk EG0012 events1 affected160 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected160 at risk
Diabetic Gastroparesis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Diverticulum Intestinal Haemorrhagic	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Faeces Discoloured	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Gastric Polyps	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Gastritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 events3 affected170 at risk EG0015 events3 affected160 at risk
Gastrointestinal Necrosis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Ileus	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Intra-Abdominal Haematoma	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Ischaemic Enteritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Large Intestinal Stenosis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Mesenteric Arterial Occlusion	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Mesenteric Haematoma	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Oesophageal Perforation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Portal Hypertensive Gastropathy	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events2 affected160 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0014 events4 affected160 at risk
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Chest Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0015 events5 affected160 at risk
Complication Associated With Device	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Death	General disorders	MedDRA 25.0	Systematic Assessment	EG00018 events18 affected170 at risk EG00124 events24 affected160 at risk
General Physical Health Deterioration	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Peripheral Swelling	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Physical Deconditioning	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Stent-Graft Endoleak	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Strangulated Hernia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Vascular Stent Occlusion	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Vascular Stent Stenosis	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0012 events2 affected160 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected160 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Kidney Transplant Rejection	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Abdominal Abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Abscess Limb	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected170 at risk EG0010 events0 affected160 at risk
Acinetobacter Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Anal Abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Appendicitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Arteriovenous Fistula Site Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected160 at risk
Arteriovenous Graft Site Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Arthritis Bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Bacterial Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Bronchitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0015 events5 affected160 at risk
Cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0008 events7 affected170 at risk EG0014 events4 affected160 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Coronavirus Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Covid-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected170 at risk EG0010 events0 affected160 at risk
Covid-19 Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Cytomegalovirus Enteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Device Related Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events2 affected170 at risk EG0010 events0 affected160 at risk
Endocarditis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Enterococcal Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Escherichia Urinary Tract Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Gangrene	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0006 events5 affected170 at risk EG0011 events1 affected160 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected170 at risk EG0011 events1 affected160 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Groin Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hordeolum	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Infected Dermal Cyst	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Influenza	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected170 at risk EG0015 events4 affected160 at risk
Intervertebral Discitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected170 at risk EG0010 events0 affected160 at risk
Klebsiella Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Localised Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Necrotising Fasciitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Osteomyelitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00011 events6 affected170 at risk EG0014 events2 affected160 at risk
Peritonitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events1 affected160 at risk
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00023 events19 affected170 at risk EG00115 events13 affected160 at risk
Pneumonia Aspiration	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected160 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Pneumonia Staphylococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Portal Pyaemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Pulmonary Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Pustule	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Pyelonephritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Respiratory Syncytial Virus Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected170 at risk EG0016 events6 affected160 at risk
Septic Shock	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected170 at risk EG0011 events1 affected160 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected170 at risk EG0012 events2 affected160 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events2 affected170 at risk EG0010 events0 affected160 at risk
Staphylococcal Osteomyelitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0016 events5 affected160 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Urosepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Viral Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Wound Infection Staphylococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Wound Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Acetabulum Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Anastomotic Stenosis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Arteriovenous Fistula Aneurysm	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG00010 events9 affected170 at risk EG00111 events10 affected160 at risk
Arteriovenous Fistula Occlusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG00019 events9 affected170 at risk EG00139 events20 affected160 at risk
Arteriovenous Fistula Site Complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG000375 events86 affected170 at risk EG001427 events96 affected160 at risk
Arteriovenous Fistula Site Haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0013 events3 affected160 at risk
Arteriovenous Fistula Site Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0010 events0 affected160 at risk
Arteriovenous Fistula Thrombosis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0007 events6 affected170 at risk EG00112 events10 affected160 at risk
Arteriovenous Graft Site Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Arteriovenous Graft Site Stenosis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0004 events1 affected170 at risk EG0016 events2 affected160 at risk
Burns Second Degree	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Complications Of Transplanted Kidney	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0011 events1 affected160 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Haemodialysis Complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0011 events1 affected160 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Inadequate Haemodialysis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Incarcerated Incisional Hernia	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Multiple Fractures	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected160 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Rectal Injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Shunt Malfunction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Skull Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0014 events2 affected160 at risk
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Vascular Access Malfunction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Vascular Access Site Pain	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Vascular Graft Complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Anticoagulation Drug Level Below Therapeutic	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Blood Pressure Decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Brain Natriuretic Peptide Increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Occult Blood	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Troponin Increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0011 events1 affected160 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0008 events7 affected170 at risk EG00111 events9 affected160 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0007 events6 affected170 at risk EG0018 events7 affected160 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected160 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Lactic Acidosis	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0010 events0 affected160 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Arthritis Reactive	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Chondrocalcinosis Pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events1 affected160 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Breast Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hepatic Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Metastases To Peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Parathyroid Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Pituitary Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Prostate Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected160 at risk
Amnesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Aphasia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Brain Stem Stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0015 events5 affected160 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0008 events4 affected170 at risk EG0012 events2 affected160 at risk
Cervical Radiculopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Cognitive Disorder	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Cubital Tunnel Syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Dementia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Dementia Alzheimer's Type	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0013 events3 affected160 at risk
Haemorrhagic Cerebral Infarction	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hypertensive Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Lacunar Infarction	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Metabolic Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected170 at risk EG0013 events2 affected160 at risk
Myelopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Narcolepsy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Presyncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events2 affected160 at risk
Spondylitic Myelopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Syncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0014 events2 affected160 at risk
Thrombotic Cerebral Infarction	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Toxic Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0005 events2 affected170 at risk EG0010 events0 affected160 at risk
Device Malfunction	Product Issues	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Confusional State	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Delirium Tremens	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Mental Status Changes	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0016 events6 affected160 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Dysuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
End Stage Renal Disease	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected170 at risk EG0018 events8 affected160 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0011 events1 affected160 at risk
Renal Cyst	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Renal Failure	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Renal Mass	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG00015 events9 affected170 at risk EG0018 events6 affected160 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0008 events5 affected170 at risk EG0012 events1 affected160 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected170 at risk EG0011 events1 affected160 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 events3 affected170 at risk EG0010 events0 affected160 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0007 events6 affected170 at risk EG0011 events1 affected160 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0014 events3 affected160 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected160 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG00110 events8 affected160 at risk
Acute Generalised Exanthematous Pustulosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected170 at risk EG0010 events0 affected160 at risk
Dermatitis Exfoliative Generalised	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Erythema Multiforme	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Ischaemic Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Skin Mass	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Loss Of Personal Independence In Daily Activities	Social circumstances	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Refusal Of Treatment By Patient	Social circumstances	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Arteriovenous Fistula Operation	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected160 at risk
Cardiac Pacemaker Replacement	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Dialysis Device Insertion	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Intervertebral Disc Operation	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Leg Amputation	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Peripheral Revascularisation	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Renal Transplant	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Aneurysm	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Aortic Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected160 at risk
Arteriosclerosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Arteriovenous Fistula	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Brachiocephalic Vein Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Dry Gangrene	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Extremity Necrosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Haematoma	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Haemorrhage	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Hypertensive Urgency	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected170 at risk EG0018 events6 affected160 at risk
Intermittent Claudication	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected160 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG00015 events10 affected170 at risk EG00113 events8 affected160 at risk
Peripheral Artery Occlusion	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0015 events2 affected160 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Peripheral Vein Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Secondary Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Steal Syndrome	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected170 at risk EG0014 events4 affected160 at risk
Subclavian Artery Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Subclavian Vein Occlusion	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected170 at risk EG0010 events0 affected160 at risk
Subclavian Vein Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk
Subclavian Vein Thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected160 at risk
Superior Vena Cava Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected160 at risk
Venous Stenosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected160 at risk
Venous Thrombosis Limb	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected160 at risk

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D016157	Vascular Fistula
D014652	Vascular Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	IN.PACT AV DCB	PTA will be performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
BG001	Standard Balloon Angioplasty	PTA will be performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IN.PACT AV DCB	PTA will be performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon	59	170	148	170	31	170
EG001	Standard Balloon Angioplasty	PTA will be performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon	60	160	143	160	32	160