RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Ang... | NCT03064126

Label	Type	Description	Intervention Names
RANGER™ Paclitaxel Coated Balloon	Experimental	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.	Device: RANGER™ Paclitaxel Coated Balloon Drug: Paclitaxel
Standard Balloon Angioplasty	Active Comparator	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.	Procedure: Standard Balloon Angioplasty

Name	Type	Description	Arm Group Labels	Other Names
RANGER™ Paclitaxel Coated Balloon	Device	A procedure that utilizes a balloon coated with paclitaxel (drug) which 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. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.

Measure	Description	Time Frame
Number of Participants With Primary Lesion Patency	RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy: There was no prespecified analysis of primary lesion patency.	12 months (RCT); 6 months (LB substudy)
Major Adverse Events (MAEs) (Primary Safety Endpoint)	RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: There was no prespecified analysis of primary safety endpoint.	Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.

Measure	Description	Time Frame
Number of Participants With Technical Success of Angioplasty Procedure	Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure. RCT Standard Balloon Angioplasty: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group.

Name	Affiliation	Role
Thomas Zeller, MD	Universitaets-Herzzentrum	Principal Investigator
Ravish Sachar, MD	University of North Carolina - Rex Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Hospital		Fairhope	Alabama	36532	United States
Rocky Mountain Regional VA Medical Center

PubMed Identifier	Type	Citation	Retractions
24920940	Background	Litsky J, Chanda A, Stilp E, Lansky A, Mena C. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery - focus on the paclitaxel eluting stent. Med Devices (Auckl). 2014 May 28;7:149-56. doi: 10.2147/MDER.S45472. eCollection 2014.
25612856	Background	Kakkar AM, Abbott JD. Percutaneous versus surgical management of lower extremity peripheral artery disease. Curr Atheroscler Rep. 2015;17(2):479. doi: 10.1007/s11883-014-0479-0.

ID	Title	Description
FG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon. RANGER™ Paclitaxel Coated Balloon: A procedure that utilizes a balloon coated with paclitaxel (drug) which 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. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries. Paclitaxel: The RANGER™ Balloon is coated with the drug Paclitaxel.

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	Oct 15, 2018

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG00252 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
Hispanic or Latino	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
New Zealand	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Smoking (Current)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Smoking (Previous)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Smoking (Never)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Smoking (Unknown)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

Current Diabetes Mellitus

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Hyperlipidemia requiring medication

History of Hyperlipidemia requiring medication rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Hypertension requiring medication

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Chronic Obstructive Pulmonary Disease

History of Chronic Obstructive Pulmonary Disease rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000275 ParticipantsBG00198 ParticipantsBG002

History of Coronary Artery Disease (CAD)

History of Coronary Artery Disease rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000276 ParticipantsBG00198 ParticipantsBG002

History of Myocardial Infarction (MI)

History of Myocardial Infarction rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000277 ParticipantsBG00197 ParticipantsBG002

History of Congestive Heart Failure (CHF)

History of Congestive Heart Failure rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000277 ParticipantsBG00198 ParticipantsBG002

NYHA Classification

NYHA classification rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00026 ParticipantsBG0019 ParticipantsBG002

History of Percutaneous Coronary Intervention (PCI)

History of Percutaneous Coronary Intervention rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG00198 ParticipantsBG002

History of Coronary Artery Bypass Graft (CABG) Surgery

History of Coronary Artery Bypass Graft rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000277 ParticipantsBG00197 ParticipantsBG002

Stable Angina

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

Unstable Angina

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

No Angina

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

Angina (Unknown)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

History of Transient Ischemic Attacks (TIA)

History of Transient Ischemic Attacks rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000275 ParticipantsBG00197 ParticipantsBG002

History of Cerebrovascular Accident (CVA)

History of Cerebrovascular Accident rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000276 ParticipantsBG00198 ParticipantsBG002

History of Renal Insufficiency

History of Renal Insufficiency rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00197 ParticipantsBG002

History of Renal Percutaneous Intervention

History of Renal Percutaneous Intervention rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000275 ParticipantsBG00197 ParticipantsBG002

History of Peripheral Vascular Surgery

History of Peripheral Vascular Surgery rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000277 ParticipantsBG00198 ParticipantsBG002

History of Endovascular Interventions

History of Endovascular Interventions rates are based on number of evaluable subjects - subjects with the data point collected.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00197 ParticipantsBG002

History of Claudication

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000278 ParticipantsBG00198 ParticipantsBG002

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 Primary Lesion Patency

RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis.

LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure.

PK Substudy: There was no prespecified analysis of primary lesion patency.

Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or bypass of the target lesion.

PK Substudy: There was no prespecified analysis of primary lesion patency.

Posted

Count of Participants

Participants

12 months (RCT); 6 months (LB substudy)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. Primary safety and effectiveness endpoints for the LB Substudy are assessed at 6 months post-procedure.

Units	Counts
Participants	OG000234 OG00186 OG00246

Title

Denominators

Categories

Title	Measurements
	OG000194 OG00157 OG00243

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		Chi-squared		0.0017		Risk Difference (RD)	0.166			1-Sided	97.5	0.0553						Superiority

Primary

Major Adverse Events (MAEs) (Primary Safety Endpoint)

RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months.

LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure.

PK Substudy: There was no prespecified analysis of primary safety endpoint.

Posted

Count of Participants

Participants

Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. Primary safety and effectiveness endpoints for the LB Substudy are assessed at 6 months post-procedure.

Secondary

Number of Participants With Technical Success of Angioplasty Procedure

Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure.

RCT Standard Balloon Angioplasty: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group.

RCT: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group.

Posted

Count of Participants

Participants

Day 0

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.

Secondary

Number of Participants With Procedural Success of Angioplasty Procedure

Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation.

Posted

Count of Participants

Participants

Day 0

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
OG003	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Secondary

Number of Participants With Clinical Success Rate Assessment

Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge.

Posted

Count of Participants

Participants

Day 0

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
OG003	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Secondary

Number of Major Adverse Event (MAE) Assessment

MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 60-months in RCT.

MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 12-months in LB substudy.

PK Substudy: There was no prespecified analysis of MAEs for PK substudy.

MAE assessment rates are based on number of evaluable subjects - subjects with the data point collected.

PK Substudy: There was no prespecified analysis of MAEs for PK substudy.

Posted

Count of Participants

Participants

60-months (RCT); 12-months (LB substudy).

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.

Secondary

Number of Clinical Events Committee (CEC) Adjudicated Events

CEC adjudicated events including death of any cause, target lesion revascularization (TLR), target vessel revascularization (TVR) and target limb amputation (TLA).

Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window.

LB substudy follow-up through 12 month.

Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window.

Posted

Number

Participants

1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.

Secondary

Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline

Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR.

LB Substudy: Follow-up through 12-month. PK Substudy: There was no prespecified analysis of Rate of Primary Sustained Clinical Improvement for PK substudy.

Primary sustained clinical improvement rates are based on number of evaluable subjects - subjects with the data point collected.

LB Substudy: Follow-up through 12-month. PK Substudy: There was no prespecified analysis of Rate of Primary Sustained Clinical Improvement for PK substudy.

Posted

Count of Participants

Participants

1, 6, 12, 24 and 36 months post-procedure (RCT); 1, 6 and 12 months post-procedure (LB substudy).

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy

Secondary

Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline.

Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.

LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Secondary Sustained Clinical Improvement for PK substudy.

Secondary sustained clinical improvement rates are based on number of evaluable subjects - subjects with the data point collected.

LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Secondary Sustained Clinical Improvement for PK substudy.

Posted

Count of Participants

Participants

1, 6, 12, 24 and 36 months post-procedure (RCT): 1, 6, and 12 months post-procedure (LB substudy)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy

Secondary

Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline.

Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization.

LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Hemodynamic Improvement for PK substudy.

Hemodynamic improvement rates are based on number of evaluable subjects - subjects with the data point collected.

LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Hemodynamic Improvement for PK substudy.

Posted

Count of Participants

Participants

1, 6, 12, 24, and 36 months post-procedure (RCT); 1, 6, and 12 months post-procedure (LB substudy)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.

Secondary

Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline

The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months.

LB Substudy: There was no prespecified analysis of Walking Improvement (distance) for the LB substudy.

PK Substudy: There was no prespecified analysis of Walking Improvement (distance) for PK substudy.

Data provided is total distance walked (m) change from baseline. Walking Improvement (distance) assessed by change in Six Minute Walk Test (6MWT) is based on number of evaluable subjects - subjects with data point collected.

LB Substudy: There was no prespecified analysis of Walking Improvement (distance) for the LB substudy.

PK Substudy: There was no prespecified analysis of Walking Improvement (distance) for PK substudy.

Posted

Mean

Standard Deviation

Meters

6 and 12 months post-procedure (RCT)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT

Secondary

Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline.

The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline.

LB Substudy: There was no prespecified analysis of Walking Improvement for the LB substudy.

PK Substudy: There was no prespecified analysis of Walking Improvement for the PK substudy.

Walking improvement rates are based on number of evaluable subjects - subjects with the data point collected.

LB Substudy: There was no prespecified analysis of Walking Improvement for the LB substudy.

PK Substudy: There was no prespecified analysis of Walking Improvement for the PK substudy.

Posted

Mean

Standard Deviation

Percentage increase

1, 6, 12, 24 and 36 months post-procedure (RCT)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.

Secondary

Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion

Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 1, 6, 12, 24 and 36 Months (RCT) Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 1, 6, and 12 (LB Substudy)

PK Substudy: There was no prespecified analysis of duplex defined binary restenosis of the target lesion

Only subjects with Diagnostic and readable PSVR values are included in the analysis.

PK Substudy: There was no prespecified analysis of duplex defined binary restenosis of the target lesion

Posted

Count of Participants

Participants

1, 6, 12, 24, and 36-months post-procedure (RCT); 1, 6, and 12-months post-procedure (LB substudy)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.

Secondary

Patient Utility Values as Assessed by Change in EQ-5D From Baseline.

Patient Utility Values as assessed by change in EQ-5D from baseline at 1, 6, 12, 24 and 36-months post-procedure. The EuroQOL (EQ)-5D is a multi-attribute health classification system. The EQ-5D uses a 5-dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) descriptive system, which each consisting of 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems/inability to perform). Outcomes reported as "Improvement" defined as improving at least one category from baseline.

LB Substudy: There was no prespecified analysis of Patient Utility Values for the LB Substudy.

PK Substudy: There was no prespecified analysis of Patient Utility Values for the PK Substudy.

Patient Utility Value improvement rates are based on number of evaluable subjects - subjects with the data point collected.

LB Substudy: There was no prespecified analysis of Patient Utility Values for the LB Substudy.

PK Substudy: There was no prespecified analysis of Patient Utility Values for the PK Substudy.

Posted

Count of Participants

Participants

1, 6, 12, 24 and 36-months post-procedure (RCT).

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.

Secondary

Changes in Healthcare Utilization Over Time

Changes in healthcare utilization over time as measured by hospitalization readmission.

Readmission Rate represents (# of subjects/Total enrolled subjects) who were hospitalized due to TLR/TVR or due to Procedure/Device related AE.

LB Substudy: Follow-up through 12 Month. PK Substudy: There was no prespecified analysis of healthcare utilization over time for the PK Substudy.

Hospitalization readmission rates are based on number of enrolled subjects.

LB Substudy: Follow-up through 12 Month. PK Substudy: There was no prespecified analysis of healthcare utilization over time for the PK Substudy.

Posted

Count of Participants

Participants

1, 6, 12, 24, 36, 48 and 60-months post-procedure (RCT); 1, 6, 12-months post-procedure (LB substudy)

ID	Title	Description
OG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
OG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.

Secondary

PK Parameters Paclitaxel (PTx) Dose

Summary of Pharmacokinetic Parameters in PK substudy. Paclitaxel (PTx) Dose

PK parameter data not collected or analyzed in RCT or LB substudy.

Posted

Mean

Standard Deviation

μg

Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

ID	Title	Description
OG000	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Units	Counts
Participants	OG000

Secondary

PK Parameters - Maximum Plasma Concentration

Summary of Pharmacokinetic Parameters in PK substudy. cmax (ng/mL) = Maximum plasma concentration

PK data not collected or analyzed in RCT or LB substudy.

Posted

Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Units	Counts
Participants	OG000

Secondary

PK Parameters - Tmax

Summary of Pharmacokinetic Parameters in PK substudy. - Tmax Tmax (h) = The timepoint where cmax is reached

PK parameter data not collected or analyzed in RCT or LB substudy.

PK data not collected or analyzed in RCT or LB substudy.

Posted

Mean

Standard Deviation

hours (h)

ID	Title	Description
OG000	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Units	Counts
Participants	OG000

Secondary

PK Parameters - Area Under the Blood Concentration Versus Time Curve From Time Zero up to the Time of the Last Quantifiable Concentration, Calculated by Trapezoidal Methods.

Summary of Pharmacokinetic Parameters in PK substudy. AUC0-t (ng*h/mL) = Area under the blood concentration versus time curve from time zero up to the time of the last quantifiable concentration, calculated by trapezoidal methods.

PK parameter data not collected or analyzed in RCT or LB substudy.

PK data not collected or analyzed in RCT or LB substudy.

Posted

Mean

Standard Deviation

ng*h/mL

ID	Title	Description
OG000	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0006 events5 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG0034 events3 affected12 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0008 events7 affected278 at risk EG0017 events7 affected98 at risk EG0021 events1 affected52 at risk EG003
Angina pectoris	Cardiac disorders	Systematic Assessment	EG00011 events11 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Angina unstable	Cardiac disorders	Systematic Assessment	EG0008 events8 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Aortic valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00014 events9 affected278 at risk EG0013 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrioventricular block	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardiac failure	Cardiac disorders	Systematic Assessment	EG00016 events10 affected278 at risk EG0014 events4 affected98 at risk EG0021 events1 affected52 at risk EG003
Cardiac failure acute	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG00011 events9 affected278 at risk EG0018 events4 affected98 at risk EG0020 events0 affected52 at risk EG003
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG00013 events12 affected278 at risk EG0016 events4 affected98 at risk EG0022 events1 affected52 at risk EG003
Coronary artery occlusion	Cardiac disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Coronary artery stenosis	Cardiac disorders	Systematic Assessment	EG0005 events4 affected278 at risk EG0014 events3 affected98 at risk EG0023 events2 affected52 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mitral valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0004 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cataract	Eye disorders	Systematic Assessment	EG0005 events5 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Eyelid cyst	Eye disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Enteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0009 events7 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0015 events5 affected98 at risk EG0021 events1 affected52 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Melaena	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Accidental death	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Catheter site haematoma	General disorders	Systematic Assessment	EG0005 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Death	General disorders	Systematic Assessment	EG0005 events5 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Device related thrombosis	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
General physical health deterioration	General disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Implant site inflammation	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0006 events6 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Cystitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Device related infection	Infections and infestations	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diverticulitis	Infections and infestations	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Enteritis infectious	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastroenteritis norovirus	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0016 events4 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG00018 events15 affected278 at risk EG0019 events9 affected98 at risk EG0024 events4 affected52 at risk EG003
Post procedural infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0005 events4 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Septic shock	Infections and infestations	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0005 events5 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Extradural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Limb traumatic amputation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Peripheral artery bypass graft stenosis	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	Systematic Assessment	EG00011 events11 affected278 at risk EG0015 events5 affected98 at risk EG0022 events2 affected52 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events5 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemoglobin decreased	Investigations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0022 events2 affected52 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mylagia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 events6 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events4 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Plantar fascitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0006 events6 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0007 events6 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0004 events3 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Dementia with Lewy bodies	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Delirium	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG00016 events11 affected278 at risk EG0016 events4 affected98 at risk EG0020 events0 affected52 at risk EG003
Calculus urinary	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urinary bladder polyp	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Prostatitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Uterine polyp	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 events6 affected278 at risk EG0019 events6 affected98 at risk EG0020 events0 affected52 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0017 events5 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Angiodysplasia	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Aortic aneurysm	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Arterial haemorrhage	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Essential hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematoma	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Intermittent claudication	Vascular disorders	Systematic Assessment	EG00048 events32 affected278 at risk EG00111 events9 affected98 at risk EG0020 events0 affected52 at risk EG003
Lower limb artery perforation	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG00024 events14 affected278 at risk EG00113 events8 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral artery occlusion	Vascular disorders	Systematic Assessment	EG00031 events22 affected278 at risk EG00111 events9 affected98 at risk EG0021 events1 affected52 at risk EG003
Peripheral artery stenosis	Vascular disorders	Systematic Assessment	EG000109 events63 affected278 at risk EG00138 events18 affected98 at risk EG0029 events7 affected52 at risk EG003
Peripheral coldness	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral embolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral ischaemia	Vascular disorders	Systematic Assessment	EG00016 events11 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral vascular disorder	Vascular disorders	Systematic Assessment	EG0005 events4 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Thrombophlebitis superficial	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Iliac artery occlusion	Vascular disorders	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dry gangrene	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyperstensive emergency	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral artery thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral venous disease	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Femoral artery aneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Impaired healing	General disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gait disturbance	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vascular stent stenosis	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vascular stent occlusion	General disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Aortic valve stenosis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Coronary artery perforation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrioventricular block complete	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardiac sarcoidosis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Sinus node dysfunction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Bradyarrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Large intestine polyp	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastric mucosal lesion	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hiatus hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mechanical ileus	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peptic ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumoperitoneum	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Umbilical hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastric antral vascular ectasia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pancreatic mass	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pancreatitis relapsing	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Gangrene	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0013 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Corona virus infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Appendicitis perforated	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Arthritis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cholecystitis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Epiglottitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Herpes zoster	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Implant site infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Joint abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Penile infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Postoperative wound infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Catheter site abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetic foot infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Infected dermal cyst	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chemical peritonitis	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Foreign body	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral artery restenosis	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Heat illness	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lung squamous cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Oral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pharyngeal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Benign mediastinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pharyngeal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0004 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
End stage renal disease	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Renal artery stenosis	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Ureteric obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ureteric stenosis	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urethral haemorrhage	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0004 events3 affected278 at risk EG0014 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Cervical myelopathy	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dementia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Depressed level of consciousness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemorrhage intracranial	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Intracranial haematoma	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peroneal nerve palsy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Presyncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cerebellar infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Metabolic encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Toxic encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Dehydration	Investigations	Systematic Assessment	EG0005 events5 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Splenic haematoma	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetic retinopathy	Eye disorders	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Macular fibrosis	Eye disorders	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cataract nuclear	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Ectropion	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cholangitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cholangitis acute	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Completed suicide	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Alcohol abuse	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Alcoholism	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Major depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Organic erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Adrenal insufficiency	Endocrine disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Sarcoidosis	Immune system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Device malfunction	Product Issues	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
C-reactive protein increased	Investigations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Streptococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Wound infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute myeloid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemorrhagic cerebral infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Arterial thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hallucination	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG0030 events0 affected12 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0005 events5 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Aortic valve stenosis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Atrioventricular block complete	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bradycardia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Thyroglossal cyst	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Blepharitis	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cataract	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetic retinopathy	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Endocrine ophthalmopathy	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Heterophoria	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mydriasis	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pterygium	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Retinal tear	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ulcerative keratitis	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vitreous degeneration	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Enteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastric polyps	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gingival bleeding	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Large intestine polyp	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Melanosis coli	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mouth ulceration	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Mucous stools	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0013 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Catheter site bruise	General disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Catheter site haematoma	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0021 events1 affected52 at risk EG003
Catheter site pain	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0006 events6 affected278 at risk EG0013 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Oedema	General disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0007 events7 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Pain	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral swelling	General disorders	Systematic Assessment	EG0004 events4 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Swelling	General disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tenderness	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Contrast media allergy	Immune system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Drug hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute sinusitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0014 events4 affected98 at risk EG0021 events1 affected52 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0006 events5 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cystitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Genital infection fungal	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Herpes zoster	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Herpes zoster oticus	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0003 events3 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Otitis media acute	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Periodontitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0006 events6 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Tracheobronchitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Viral infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vulval abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Wound infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0006 events6 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Eschar	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Face injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Joint injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Subcutaneous haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vascular access site haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	Systematic Assessment	EG00011 events11 affected278 at risk EG0012 events2 affected98 at risk EG0021 events1 affected52 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Ankle brachial index decreased	Investigations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Blood pressure increased	Investigations	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Blood urine present	Investigations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Carotid bruit	Investigations	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Lipids abnormal	Investigations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pulse absent	Investigations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Right ventricular systolic pressure	Investigations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Ultrasound Doppler abnormal	Investigations	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Weight decreased	Investigations	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events5 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 events11 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 events9 affected278 at risk EG0014 events4 affected98 at risk EG0022 events2 affected52 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events5 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00016 events15 affected278 at risk EG0017 events7 affected98 at risk EG0022 events2 affected52 at risk EG003
Plantar fascitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tendon pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Wrist deformity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Benign neoplasm of adrenal gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hepatocellular carinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Amnesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ataxia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Balance disorder	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Carotid artery aneurysm	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Carotid artery disease	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0016 events5 affected98 at risk EG0020 events0 affected52 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Migraine	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Neuralgia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Parkinson's disease	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Postural tremor	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Presyncope	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Restless legs syndrome	Nervous system disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Sciatica	Nervous system disorders	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Trigeminal neuralgia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Middle insomnia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0021 events1 affected52 at risk EG003
Nephritis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Neurogenic bladder	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Nocturia	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Renal disorder	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urinary hesitation	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Prostatitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0016 events4 affected98 at risk EG0022 events2 affected52 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Epiglottic mass	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Chronic pigmented purpura	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0021 events1 affected52 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected98 at risk EG0020 events0 affected52 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Blue toe syndrome	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Embolism arterial	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Haematoma	Vascular disorders	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Haemorrhage	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG00010 events9 affected278 at risk EG0013 events3 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Intermittent claudication	Vascular disorders	Systematic Assessment	EG00037 events31 affected278 at risk EG00113 events11 affected98 at risk EG0022 events2 affected52 at risk EG003
Internal haemorrhage	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected98 at risk EG0022 events1 affected52 at risk EG003
Peripheral artery occlusion	Vascular disorders	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected98 at risk EG0021 events1 affected52 at risk EG003
Peripheral artery stenosis	Vascular disorders	Systematic Assessment	EG00018 events17 affected278 at risk EG0016 events6 affected98 at risk EG0026 events6 affected52 at risk EG003
Peripheral venous disease	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Subclavian steal syndrome	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Varicose vein	Vascular disorders	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Phlebitis	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Ischaemic limb pain	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Spinal disorder	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Gangrene	Infections and infestations	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Angina unstable	Cardiac disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Lacrimation increased	Eye disorders	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Vision blurred	Eye disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypoacusis	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Foreign body	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Renal cyst	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0020 events0 affected52 at risk EG003
Dementia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003
Lumbar hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected98 at risk EG0021 events1 affected52 at risk EG003

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D058226	Plaque, Atherosclerotic
D001157	Arterial Occlusive Diseases
D058225	Plaque, Amyloid

ID	Term
D001161	Arteriosclerosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016491	Peripheral Vascular Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures
D008919	Investigative Techniques
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	RANGER™ Paclitaxel Coated Balloon RCT	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
BG001	Standard Balloon Angioplasty RCT	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
BG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
BG003	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
BG004	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	RANGER™ Paclitaxel Coated Balloon	RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.	44	278	212	278	176	278
EG001	Standard Balloon Angioplasty	Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.	20	98	73	98	63	98
EG002	Long Balloon (LB) Substudy	The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.	2	52	23	52	26	52
EG003	Pharmacokinetics (PK) Substudy	The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.	3	12	10	12	9	12