Lutonix DCB Versus Standard Balloon Angioplasty for Treat... | NCT01870401

Name	Class
Bard Ltd	INDUSTRY

Label	Type	Description	Intervention Names
Lutonix DCB	Experimental	Lutonix Paclitaxel Drug Coated Balloon	Device: Lutonix DCB
PTA Catheter	Active Comparator	Standard Uncoated PTA Catheter	Device: Uncoated PTA Catheter

Name	Type	Description	Arm Group Labels	Other Names
Lutonix DCB	Device		Lutonix DCB	LTX DCB
Uncoated PTA Catheter

Measure	Description	Time Frame
Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure.	The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.	30 days post index procedure
Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure.	The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb.	6 months post-index procedure

Measure	Description	Time Frame
Percentage of Lesions Considered Technical Success at Time of Index Procedure	Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation ≤ 30% was reported.	At time of index procedure
Percentage of Procedures With Procedural Success at Time of Index Procedure.

Name	Affiliation	Role
Patrick Geraghty, MD	Washington University School of Medicine	Principal Investigator
Jihad Mustapha, MD	Metro Health Hospital	Principal Investigator
Marianne Brodmann, MD	Medical University Graz, Austria	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yale University-Yale New Haven Hospital		New Haven	Connecticut	06510	United States
MedStar Washington Hospital Center

ID	Title	Description
FG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 7, 2017

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

Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure.

The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Participants

Participants

30 days post index procedure

ID	Title	Description
OG000	Lutonix DCB	Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB
OG001	PTA Catheter	Standard Uncoated PTA Catheter Uncoated PTA Catheter

Units	Counts
Participants	OG000286 OG001155

Title

Denominators

Categories

Title	Measurements
	OG000284 OG001154

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	The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB < where p is the success rate in each arm and (alpha) is the non-inferiority bound.	Farrington and Manning		<0.025														Non-Inferiority	The protocol identified a non-inferiority bound equal to 0.12 (12%).

Primary

Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure.

The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Participants

Participants

6 months post-index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Lesions Considered Technical Success at Time of Index Procedure

Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation ≤ 30% was reported.

Posted

Number

95% Confidence Interval

percentage of lesions

At time of index procedure

Lesions

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Procedures With Procedural Success at Time of Index Procedure.

A success is determined if there is restoration of at least 1 infrapopliteal artery with residual stenosis ≤ 30% (or ≤ 50% depending upon the version of the protocol) and inline outflow to the foot, irrespective of device success, and without a major adverse event during the index procedure.

Posted

Number

95% Confidence Interval

Percentage of Procedures

At time of Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Comparison of the Below the Knee (BTK) Major Adverse Limb Event (MALE) and Perioperative Death (POD) Rate to a Performance Goal at 30 Days Post Index Procedure.

Data were not collected.

Posted

30 days post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.

Mean change in EuroQol (EQ-5D) scores at 30 days, 6, and 12 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Mean

Standard Deviation

Scores on a scale

30 days, 6 and 12 months post index procedure compared to baseline

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Late Lumen Loss at 12 Months Post Index Procedure

Data were not collected.

Posted

12 months post-index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. The number of wounds analyzed at 6 and 12 months post-index procedure includes wounds that may have appeared (new wounds) since the previous time period reporting.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Units

Wounds

30 days, 6 and 12 months post index procedure

Wounds

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Units

Non-Healed Wounds

30 days, 6 and 12 months post index procedure

Non-Healed Wounds

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Participants may have more than one wound type or wounds in more than one location. The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Units

Wounds

30 days, 6 and 12 months post index procedure

Wounds

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.

The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 36 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Participants

Participants

30 days, 6 and 12 months post index procedure compared to baseline

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.

The composite endpoint of freedom from above ankle amputation (CEC-adjudicated), unhealed wound (presence of wound vs. no wound), ischemic rest pain (Rutherford category 4 or higher), target vessel occlusion (based on DUS and/or angiograph), and clinically-driven TVR (CEC-adjudicated).

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Participants

Participants

30 days, 6 and 12 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter

Secondary

Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure

Primary patency is defined as the absence of both total occlusion (100% diameter stenosis) in all of the target lesions in a flow pathway as well as a clinically-driven Target Lesion Revascularization (TLR).

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants or lesions may vary depending on the number of participants/lesions for which data was available at the given time-point analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

30 days and at 6 and 12 months

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure

Primary patency with exclusion of early mechanical recoil of the target flow pathway is defined as the absence of both total occlusion (100% diameter stenosis) of the target lesions and clinically-driven TLR events > 30 days.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants or lesions may vary depending on the number of participants/lesions for which data was available at the given time-point analysis.

Posted

Number

95% Confidence Interval

Percentage of Lesions

30 days, 6 and 12 months post index procedure

Lesions

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure

The secondary patency of the target lesion is defined as the absence of total occlusion (100% diameter stenosis) of the target lesions based on angiography (if performed) or ultrasound as analyzed by the angiographic Core Lab.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis

Posted

Number

Lesions

30 days, 6 and 12 months post index procedure

Lesions

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Composite of Freedom From Clinically -Driven Target Lesion Revascularization (TLR) and From 50% DS by Angiography or Duplex Ultrasound at 30 Days, 6 and 12 Months Post Index Procedure.

Data were not collected.

Posted

30 days, 6 and 12 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline

Mean change from baseline values. The Toe Brachial Index (TBI) is defined as a ratio of toe to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Mean

Standard Deviation

Ratio

30 days, 6 and 12 months post index procedure compared to baseline

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline

Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Mean

Standard Deviation

Ratio

30 days, and at 6 and 12 months compared to baseline

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.

The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days 6 and 12 months, compared to baseline assessment scores.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Mean

Standard Deviation

score on a scale

30 days, 6 and 12 months post index procedure compared to baseline

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001

Secondary

Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure

Data were not collected.

Posted

30 days, 6 and 12 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Posted

Number

participants

30 days, 6 and 12 months post index procedure

Target Lesions Revascularization

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.

Data were not collected.

Posted

30 days, 6 and 12 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.

Posted

Number

Target Vessel Revascualarization

30 days, 6 and 12 months post index procedure

Target Vessel Revascularization

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure

Limb salvage defined as no amputation of target limb.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Number

95% Confidence Interval

percentage of participants

30 days and at 6 and 12 months

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure.

Defined as amputation that was below the ankle, including digit amputation. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

30 days, 6 and 12 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.

The overall burden of BTK reinterventions was defined as the total number of BTK index-limb re-interventions and major amputations for each time point.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Posted

Number

Limb Reintervention

30 days, 6 and 12 months post index procedure

Limb Reintervention

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

30 days, 6 and 12 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment		EG00010 affected287 at risk EG0013 affected155 at risk
Anaemia Of Chronic Disease	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Heparin-Induced Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0011 affected155 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG00014 affected287 at risk EG0018 affected155 at risk
Angina Pectoris	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0008 affected287 at risk EG0016 affected155 at risk
Angina Unstable	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0010 affected155 at risk
Aortic Valve Disease	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0012 affected155 at risk
Arrhythmia Supraventricular	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG00010 affected287 at risk EG0016 affected155 at risk
Atrial Flutter	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Atrioventricular Block	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0012 affected155 at risk
Cardiac Failure	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG00011 affected287 at risk EG0015 affected155 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0011 affected155 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG00021 affected287 at risk EG00112 affected155 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Cardiomegaly	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG00011 affected287 at risk EG0015 affected155 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0011 affected155 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0006 affected287 at risk EG0012 affected155 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0012 affected155 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0012 affected155 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Pericarditis	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Pulseless Electrical Activity	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Tachycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Tricuspid Valve Disease	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Tricuspid Valve Incompetence	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Buried Penis Syndrome	Congenital, familial and genetic disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Angle Closure Glaucoma	Eye disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Cataract	Eye disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Diabetic Retinopathy	Eye disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Eye Haemorrhage	Eye disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Abdominal Wall Haematoma	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Dental Caries	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Faecal Incontinence	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0007 affected287 at risk EG0012 affected155 at risk
Gastrointestinal Oedema	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Inguinal Hernia, Obstructive	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Intestinal Mass	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Ischaemic Enteritis	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Mesenteric Artery Stenosis	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Oesophagitis Ulcerative	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Retroperitoneal Haematoma	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Vomiting	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Adverse Drug Reaction	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Chest Pain	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Death	General disorders	MedDRA (16.1)	Systematic Assessment		EG0008 affected287 at risk EG0011 affected155 at risk
Device Battery Issue	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Device Dislocation	General disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Device Occlusion	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Disease Progression	General disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0010 affected155 at risk
Impaired Healing	General disorders	MedDRA (16.1)	Systematic Assessment		EG0008 affected287 at risk EG0013 affected155 at risk
Local Swelling	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Oedema Peripheral	General disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Pyrexia	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0010 affected155 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vessel Puncture Site Haemorrhage	General disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Abscess Limb	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Appendicitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Arthritis Bacterial	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Atypical Pneumonia	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Bacteraemia	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Bronchitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0011 affected155 at risk
Bronchopulmonary Aspergillosis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Cellulitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG00013 affected287 at risk EG0016 affected155 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0012 affected155 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Cystitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Diabetic Foot Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Diverticulitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Emphysematous Cystitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Endocarditis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Erysipelas	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Gangrene	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG00022 affected287 at risk EG00111 affected155 at risk
Gastritis Viral	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Gastroenteritis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0012 affected155 at risk
Groin Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Herpes Zoster	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Influenza	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Intervertebral Discitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0012 affected155 at risk
Localised Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG00010 affected287 at risk EG0015 affected155 at risk
Lung Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Osteomyelitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG00021 affected287 at risk EG00116 affected155 at risk
Paronychia	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Pneumonia	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG00015 affected287 at risk EG0017 affected155 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Pyelonephritis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Sepsis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0008 affected287 at risk EG0015 affected155 at risk
Septic shock	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0013 affected155 at risk
Serratia Bacteraemia	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Sputum Purulent	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0009 affected287 at risk EG0016 affected155 at risk
Urosepsis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0012 affected155 at risk
Vaginal Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Wound Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0008 affected287 at risk EG0012 affected155 at risk
Anaemia Postoperative	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0012 affected155 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Iatrogenic Injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Meniscus Injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Peripheral Arterial Reocclusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG00035 affected287 at risk EG00111 affected155 at risk
Peripheral Artery Restenosis	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG00062 affected287 at risk EG00136 affected155 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Skin Injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Subcutaneous Haematoma	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Vascular Graft Complication	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vascular Graft Thrombosis	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG00015 affected287 at risk EG0016 affected155 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Wound Haemorrhage	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Wound Necrosis	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Blood Creatinine Increased	Investigations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Blood Culture Positive	Investigations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Blood Glucose Fluctuation	Investigations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Blood Pressure Decreased	Investigations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Haemoglobin Decreased	Investigations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Investigation	Investigations	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Radioisotope Scan Abnormal	Investigations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Troponin Increased	Investigations	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0011 affected155 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0011 affected155 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0010 affected155 at risk
Joint Contracture	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0007 affected287 at risk EG0011 affected155 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Soft Tissue Mass	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Adenosquamous Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Lip And/Or Oral Cavity Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Non-Hodgkin's Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Pancreatic Carcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Pharyngeal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Squamous Cell Carcinoma Of Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Amnesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Brain Stem Stroke	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0013 affected155 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Cerebral Infarction	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0011 affected155 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0006 affected287 at risk EG0013 affected155 at risk
Cerebrovascular Disorder	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Convulsion	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Dementia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Dizziness	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Embolic Stroke	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Encephalopathy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Hemiparesis	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Lacunar Infarction	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Metabolic Encephalopathy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Parkinson's Disease	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Precerebral Artery Occlusion	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Somnolence	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Syncope	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0006 affected287 at risk EG0011 affected155 at risk
Toxic Encephalopathy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0010 affected155 at risk
Vascular Dementia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Anxiety	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Depression	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Mental Status Changes	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0012 affected155 at risk
Neglect Of Personal Appearance	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Bladder Mass	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Haematuria	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Nephropathy	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Nephropathy Toxic	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Obstructive Uropathy	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Pyuria	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Renal Failure	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG00010 affected287 at risk EG0017 affected155 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG00012 affected287 at risk EG0013 affected155 at risk
Renal Impairment	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Ureteric Stenosis	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0015 affected155 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0006 affected287 at risk EG0010 affected155 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0006 affected287 at risk EG0011 affected155 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0011 affected155 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0012 affected155 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0015 affected155 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Diabetic Ulcer	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Dry Gangrene	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Leukocytoclastic Vasculitis	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment		EG00017 affected287 at risk EG00112 affected155 at risk
Accelerated Hypertension	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Aortic Aneurysm	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Aortic Stenosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0010 affected155 at risk
Arterial Rupture	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Arteritis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0006 affected287 at risk EG0012 affected155 at risk
Diabetic Macroangiopathy	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Embolism Arterial	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0012 affected155 at risk
Extremity Necrosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0011 affected155 at risk
Haemorrhage	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Hypertension	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0004 affected287 at risk EG0011 affected155 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Hypertensive Emergency	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0010 affected155 at risk
Hypotension	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0002 affected287 at risk EG0012 affected155 at risk
Intermittent Claudication	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0013 affected155 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG00058 affected287 at risk EG00116 affected155 at risk
Peripheral Artery Dissection	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0009 affected287 at risk EG0012 affected155 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG00058 affected287 at risk EG00135 affected155 at risk
Peripheral Artery Thrombosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0013 affected155 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0005 affected287 at risk EG0012 affected155 at risk
Varicose Vein	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Vascular Insufficiency	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vasospasm	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0003 affected287 at risk EG0012 affected155 at risk
Venous Insufficiency	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0012 affected155 at risk
Venous Thrombosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Vessel Perforation	Vascular disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0010 affected155 at risk
Bradycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment		EG0001 affected287 at risk EG0012 affected155 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment		EG0000 affected287 at risk EG0011 affected155 at risk
Acute Ischemia Left Lower Leg	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0000 affected287 at risk EG0011 affected155 at risk
Admission to Psychiatry	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0001 affected287 at risk EG0010 affected155 at risk
Chest Pain Syndrome with Acute Moderate Pericardia	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0001 affected287 at risk EG0010 affected155 at risk
Claudication Left Leg	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0000 affected287 at risk EG0011 affected155 at risk
Gangrene on Left Great Toe	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0000 affected287 at risk EG0011 affected155 at risk
I & D with Partial Left Hallux Amputation	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0000 affected287 at risk EG0011 affected155 at risk
Occluded Left Sfa Stent	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0001 affected287 at risk EG0010 affected155 at risk
Occlusion of Right At & Dp	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0001 affected287 at risk EG0010 affected155 at risk
Occlusion of Left At and Stenosis of Left Tpt	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0000 affected287 at risk EG0011 affected155 at risk
Profundus Stenosis	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0001 affected287 at risk EG0010 affected155 at risk
Ulcerated Basalioma Left Eyelid	General disorders	MedDRA (16.1)	Systematic Assessment	This SAE was uncoded in terms of Organ System in the Clinical Study Report and therefore, is added here under "General Disorders".	EG0001 affected287 at risk EG0010 affected155 at risk

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016491	Peripheral Vascular Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007511	Ischemia

ID	Title	Description
BG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
BG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
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	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	48	287	240	287	106	287
EG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	25	155	126	155	45	155

Units	Counts
Participants	OG000287 OG001155
Target Vessel Revascularization	OG000175 OG00179