GORE VIABAHN Endoprosthesis Versus Percutaneous Translumi... | NCT00737672

ID	Type	Description	Link
G070069	Other Identifier	FDA (IDE)

Label	Type	Description	Intervention Names
VIABAHN Treatment Group	Experimental	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm	Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
PTA Treatment Group	Active Comparator	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm	Procedure: Percutaneous Transluminal Angioplasty

Name	Type	Description	Arm Group Labels	Other Names
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface	Device	Deployment of investigational stent graft at the venous anastomosis	VIABAHN Treatment Group

Measure	Description	Time Frame
Target Lesion Primary Patency at 6 Months	Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.	6 months
Target Lesion Primary Patency at 12 Months	Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.	12 Months
Target Lesion Primary Patency at 24 Months	Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion.	24 Months
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure	The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.	30 days

Measure	Description	Time Frame
Assisted Primary Patency at 6 Months	Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.	6 months
Assisted Primary Patency at 12 Months

Name	Affiliation	Role
Tom Vesely, MD	Vascular Access Center; Frontenac, MO	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35249	United States

PubMed Identifier	Type	Citation	Retractions
30717951	Derived	Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial. J Vasc Interv Radiol. 2019 Feb;30(2):203-211.e4. doi: 10.1016/j.jvir.2018.12.006.

ID	Title	Description
FG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis

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 at 6 Months

Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

6 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Units	Counts
Participants	OG000131 OG001138

Title

Denominators

Categories

Title	Measurements
	OG00052.9(43.8 to 61.1) OG00135.5(27.4 to 43.6)

Primary

Target Lesion Primary Patency at 12 Months

Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

12 Months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Assisted Primary Patency at 6 Months

Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

6 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Assisted Primary Patency at 12 Months

Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

12 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Assisted Primary Patency at 24 Months

Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

24 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Access Secondary Patency at 6 Months

Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

Six-month estimate of secondary access patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

6 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Access Secondary Patency [12 Months] Units Percentage of Subjects

Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

12 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Access Secondary Patency [24 Months] Units Percentage of Subjects

Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

24 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Primary

Target Lesion Primary Patency at 24 Months

Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

P-Value calculated from 24-month data cohort after study completion.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

24 Months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Primary

Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure

The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.

Posted

Number

Participants

30 days

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Units	Counts
Participants

Secondary

Circuit Primary Patency

Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.

P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve.

Posted

Number

95% Confidence Interval

Percentage of Subjects

6 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Units	Counts

Secondary

Circuit Primary Patency [12 Months] Units Percentage of Subjects

Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

12months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Circuit Primary Patency [24 Months] Units Percentage of Subjects

Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.

Posted

Number

95% Confidence Interval

Percentage of Subjects

24 months

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Secondary

Clinical Success

The resumption of normal dialysis for at least one session following study treatment (Index Procedure).

Posted

Number

Participants

Following Index Procedure

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Units	Counts
Participants

Secondary

Anatomic Success

Less than 30 percent residual stenosis following study treatment (Index Procedure).

Posted

Number

Participants

Index Procedure

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Units	Counts
Participants	OG000

Secondary

Procedural Success

Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.

Posted

Number

Participants

Following Index Procedure

ID	Title	Description
OG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis
OG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Anemia of chronic disease	Blood and lymphatic system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Anginal pain	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0011 affected148 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0012 affected148 at risk
Atrial fibrillation with rapid ventricular response	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Bradycardia	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0004 affected145 at risk EG0012 affected148 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0006 affected145 at risk EG0018 affected148 at risk
Cardiopulmonary arrest	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0012 affected148 at risk
Chest pain	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Congestive heart failure	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0011 affected148 at risk
Coronary artery disease	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Junctional bradycardia	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0004 affected145 at risk EG0010 affected148 at risk
Non STEMI	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0011 affected148 at risk
Tachycardia NOS	Cardiac disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Polycystic hepatorenal disease	Congenital, familial and genetic disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Addison's disease	Endocrine disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Blurry vision	Eye disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Cataract	Eye disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Retinal detachment	Eye disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Retinal vascular occlusion	Eye disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Abdominal pain aggravated	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Acute duodenal ulcer with hemorrhage	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Acute pancreatitis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Bleeding gastric ulcer	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Blood in stool	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Diarrhea	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Diverticulum intestinal hemorrhagic	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
GI bleed	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0012 affected148 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Gastroparesis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Hematochezia	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Internal hemorrhoids	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Lower gastrointestinal bleeding	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Melena	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Mesenteric ischemia	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Pancreatitis acute on chronic	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Pancreatitis due to gallstones	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Peptic ulcer disease	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Rectal bleeding	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Right-sided colitis	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Small bowel obstruction	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Upper gastrointestinal bleeding	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0012 affected148 at risk
Upper gastrointestinal symptoms	Gastrointestinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Adverse drug reaction	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Catheter site bleeding	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Chest pain	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0008 affected145 at risk EG0016 affected148 at risk
Debility marked	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Ill-defined disorder	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Incarcerated hernia	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Intraocular lens dislocation	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pain at rest	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Peritoneal catheter dysfunction	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Sudden cardiac death	General disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Acute cholecystitis	Hepatobiliary disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Biliary stasis	Hepatobiliary disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Allergic reaction to antibiotics	Immune system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0012 affected148 at risk
Abscess dental	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Abscess leg	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Abscess of finger	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Acute tracheobronchitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0005 affected145 at risk EG0019 affected148 at risk
Bacteremia	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0005 affected145 at risk EG0010 affected148 at risk
Bacterial endocarditis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Biliary sepsis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Bronchitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0010 affected148 at risk
C.difficile colitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Candida sepsis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Cellulitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Cellulitis of arm	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Cellulitis of foot	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Cellulitis of leg	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Cellulitis of legs	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Community acquired pneumonia	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Diabetic foot infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Diverticulitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Foot infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Gangrene	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0005 affected145 at risk EG0015 affected148 at risk
Hospital acquired infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Infection of amputation stump	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Leg infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0011 affected148 at risk
Pneumonia	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0018 affected148 at risk
Pneumonia aspergillus	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Recurrent urinary tract infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Sepsis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0005 affected145 at risk EG0015 affected148 at risk
Sepsis MRSA	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0012 affected148 at risk
Septic shock	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0010 affected148 at risk
Shingles	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Staphylococcal bacteremia	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Streptococcal cellulitis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0014 affected148 at risk
Urosepsis	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Viral syndrome	Infections and infestations	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Acute subdural hematoma	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Arteriovenous graft site bleeding	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0004 affected145 at risk EG0013 affected148 at risk
Arteriovenous graft site hematoma	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Arteriovenous graft site hemorrhage	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Bleeding postoperative	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Cervical vertebral fracture C2	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Fracture of upper end or unspecified part of tibia and fibula, closed	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Hemodialysis-induced symptom	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Hypotension during dialysis	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Lower limb wound	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Postoperative bleeding	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Electrocardiogram abnormal non-specific	Investigations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Troponin increased	Investigations	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Diabetes mellitus poor control	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0005 affected145 at risk EG0012 affected148 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0006 affected145 at risk EG0017 affected148 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0013 affected148 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Volume overload	Metabolism and nutrition disorders	MedDRA Version 16.1	Systematic Assessment	EG00011 affected145 at risk EG0015 affected148 at risk
Avascular necrosis femoral head	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Hand pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Jaw pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Leg pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Osteoarthritis aggravated	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Osteoarthritis of cervical spine	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pain in arm	Musculoskeletal and connective tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Hepatic adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0014 affected148 at risk
Dizziness	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Encephalopathy acute	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Slurred speech	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Stroke	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Syncope	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Tonic-clonic seizures	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Transient ischemic attack	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0011 affected148 at risk
Tremor	Nervous system disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Mental status changes	Psychiatric disorders	MedDRA Version 16.1	Systematic Assessment	EG0003 affected145 at risk EG0012 affected148 at risk
End stage renal disease (ESRD)	Renal and urinary disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0014 affected148 at risk
Hematuria	Renal and urinary disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Kidney failure	Renal and urinary disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Renal mass	Renal and urinary disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Uremia	Renal and urinary disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Acute on chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Flash pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Lung nodule	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Non-cardiogenic pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Orthopnea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0012 affected148 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Pulmonary infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0010 affected148 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Vocal cord dysfunction	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Facial swelling	Skin and subcutaneous tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Foot ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Heel ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Leg ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Venous stasis ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Anticoagulant therapy	Surgical and medical procedures	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Blood pressure management	Surgical and medical procedures	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Kidney transplant	Surgical and medical procedures	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Toe amputation	Surgical and medical procedures	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Accelerated Hypertension	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Arterial embolism NOS	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Atherosclerosis of arteries of the extremities	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Critical limb ischemia	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Deep venous thrombosis arm	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Hypertension	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Hypertensive emergency	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0011 affected148 at risk
Hypertensive urgency	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0012 affected148 at risk
Malignant hypertension	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected148 at risk
Peripheral arterial disease	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0012 affected148 at risk
Peripheral ischemia	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0012 affected148 at risk
Uncontrolled hypertension	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk
Venous (peripheral) insufficiency, unspecified	Vascular disorders	MedDRA Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected148 at risk

ID	Title	Description
BG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm. GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis.
BG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm. Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis.
BG002	Total	Total of all reporting groups

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures
D008919	Investigative Techniques

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VIABAHN Treatment Group	Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm			78	145	4	145
EG001	PTA Treatment Group	Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm			77	148	8	148