ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent | NCT02574481

Label	Type	Description	Intervention Names
ELUVIA Stent Implantation	Experimental	Percutaneous stent placement in the SFA/PPA	Device: ELUVIA (Stent Implantation)
Zilver PTX Stent Implantation	Active Comparator	Percutaneous stent placement in the SFA/PPA	Device: Zilver PTX (Stent Implantation)

Name	Type	Description	Arm Group Labels	Other Names
ELUVIA (Stent Implantation)	Device	Drug-eluting self-expanding stent implantation during the index procedure.	ELUVIA Stent Implantation

Measure	Description	Time Frame
Percentage of Participants With Major Adverse Events (MAEs)	MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months	12 Months
Number of Participants Reaching Primary Patency	Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory	12 Months

Measure	Description	Time Frame
Number of CEC-adjudicated Events Through 12 Months	Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.	12 Months
Count of Participants Meeting Primary Sustained Clinical Improvement

Measure	Description	Time Frame
Freedom From Major Adverse Events	Percentage of participants without Major Adverse Events (MAEs)	Through 60 Months
Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate

Name	Affiliation	Role
William Gray, MD	Main Line Health	Principal Investigator
Stefan Müller-Hülsbeck, Prof	Ev. Luth. Diakonissenanstalt Flensburg	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yuma Regional Medical Center		Yuma	Arizona	85364	United States
University of California, Davis Medical Center

PubMed Identifier	Type	Citation	Retractions
34235560	Derived	Iida O, Fujihara M, Kawasaki D, Mori S, Yokoi H, Miyamoto A, Kichikawa K, Nakamura M, Ohki T, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA, Soga Y. 24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021 Sep;44(9):1367-1374. doi: 10.1007/s00270-021-02901-6. Epub 2021 Jul 7.
33225377

ID	Title	Description
FG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
FG001	Zilver PTX Stent Implantation

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	Mar 7, 2016

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

Percentage of Participants With Major Adverse Events (MAEs)

MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months

Posted

Number

percentage of participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy	To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.

Units	Counts
Participants	OG000287 OG001132 OG00250 OG003

Title

Denominators

Categories

All Causes of Death at 1 Month

Title	Measurements
	OG0000 OG0010 OG0020 OG003

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		Farrington-Manning		<0.0001	A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is <0.05, Eluvia is concluded to be non-inferior to Zilver PTX.													Non-Inferiority	A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.

Primary

Number of Participants Reaching Primary Patency

Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory

Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or, bypass of the target lesion before or on the DUS FU visit. Per PK sub-study design, primary efficacy (patency) not analyzed.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

Secondary

Number of CEC-adjudicated Events Through 12 Months

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

Posted

Number

participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003

Secondary

Count of Participants Meeting Primary Sustained Clinical Improvement

Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.

Per PK sub-study design, secondary endpoint not analyzed.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy

Secondary

Number of Participants With Hemodynamic Improvement

Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.

Per PK sub-study design, secondary endpoint not analyzed.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy

Secondary

Walking Impairment Questionnaire (WIQ) Scores

The WIQ is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. WIQ scores reported as change from baseline.

Not all subjects were able to complete questionnaires.Per PK sub-study design, secondary endpoint not analyzed.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to 12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

Secondary

6-Minute Walk Test - Distance Walked

Change in distance walked from baseline to 12 months.

Per PK sub-study design, secondary endpoint not analyzed.

Posted

Mean

Standard Deviation

Change in baseline to 12-Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy	To evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.

Secondary

6-Minute Walk Test - Speed

Change in speed walked from baseline to 12 months

Per PK sub-study design, secondary endpoint not analyzed.

Posted

Mean

Standard Deviation

m/min

Baseline to 12 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy	To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.

Other Pre-specified

Freedom From Major Adverse Events

Percentage of participants without Major Adverse Events (MAEs)

PK Substudy cohort was not included in this outcome

Posted

Count of Participants

Participants

Through 60 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy

Other Pre-specified

Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate

Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization rate

PK Substudy cohort was not included in this outcome

Posted

Count of Participants

Participants

Through 60 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy

Other Pre-specified

Percentage of Participants With Target Limb Major Amputation

Clinical Events Committee (CEC) adjudicated target limb major amputation rate

PK Substudy cohort was not included in this outcome

Posted

Count of Participants

Participants

Through 60 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
OG003	PK Substudy

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Peripheral artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG000144 events85 affected309 at risk EG00173 events42 affected156 at risk EG00214 events10 affected50 at risk EG0032 events2 affected13 at risk
Intermittent claudication	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00055 events36 affected309 at risk EG00120 events13 affected156 at risk EG00214 events9 affected50 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00042 events27 affected309 at risk EG00119 events15 affected156 at risk EG0024 events3 affected50 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00035 events27 affected309 at risk EG0018 events6 affected156 at risk EG0024 events4 affected50 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00019 events14 affected309 at risk EG0014 events4 affected156 at risk EG0020 events0 affected50 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0013 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Haematoma	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Arterial spasm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Embolism	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events5 affected309 at risk EG0019 events8 affected156 at risk EG0022 events2 affected50 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00018 events14 affected309 at risk EG0019 events8 affected156 at risk EG0022 events2 affected50 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00016 events15 affected309 at risk EG0014 events4 affected156 at risk EG0022 events2 affected50 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00017 events16 affected309 at risk EG0016 events6 affected156 at risk EG0021 events1 affected50 at risk EG003
Cardiac Failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00015 events14 affected309 at risk EG0015 events5 affected156 at risk EG0026 events5 affected50 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00015 events13 affected309 at risk EG0016 events6 affected156 at risk EG0022 events2 affected50 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events4 affected309 at risk EG0014 events3 affected156 at risk EG0021 events1 affected50 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00011 events6 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events7 affected309 at risk EG0013 events3 affected156 at risk EG0021 events1 affected50 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events6 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0013 events3 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Tricuspid valve stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00019 events16 affected309 at risk EG00117 events15 affected156 at risk EG00210 events8 affected50 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gangrene	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 events4 affected309 at risk EG0015 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0016 events5 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0013 events3 affected156 at risk EG0023 events2 affected50 at risk EG003
Urosepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Erysipelas	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Appendicitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Bronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Catheter site infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Lung abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events4 affected309 at risk EG0012 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0017 events5 affected156 at risk EG0020 events0 affected50 at risk EG003
Intervetebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected309 at risk EG0014 events4 affected156 at risk EG0020 events0 affected50 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Coeliac artery stenosis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Epiploic appendagitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events3 affected309 at risk EG0011 events1 affected156 at risk EG0024 events2 affected50 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected309 at risk EG0015 events5 affected156 at risk EG0021 events1 affected50 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events7 affected309 at risk EG0012 events2 affected156 at risk EG0022 events2 affected50 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Presyncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Sciatica	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Syncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0022 events2 affected50 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0013 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00011 events7 affected309 at risk EG0017 events6 affected156 at risk EG0021 events1 affected50 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected309 at risk EG0013 events3 affected156 at risk EG0021 events1 affected50 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events3 affected309 at risk EG0012 events2 affected156 at risk EG0023 events3 affected50 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0013 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0004 events3 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Hip Fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0004 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events1 affected309 at risk EG0010 events0 affected156 at risk EG0022 events2 affected50 at risk EG003
Catheter site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected309 at risk EG0014 events4 affected156 at risk EG0022 events2 affected50 at risk EG003
Chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
General physical health deterioration	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Impaired healing	General disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events4 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Multi-organ failure	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Therapeutic response decreased	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Treatment failure	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events10 affected309 at risk EG0013 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected309 at risk EG0013 events3 affected156 at risk EG0020 events0 affected50 at risk EG003
Oral neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
B-Cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events4 affected309 at risk EG0013 events3 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events7 affected309 at risk EG0014 events4 affected156 at risk EG0020 events0 affected50 at risk EG003
Endocrine disorder	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Goitre	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Depression	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Retinal detachment	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Macular degeneration	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Breast disorder	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Embolism venous	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Arteriovenous fistula	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Iliac artery rupture	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral artery dissection	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Steal syndrome	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Venous stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Embolism arterial	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoperfusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiovascular disorder	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Corona virus infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0013 events3 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cystitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Device related infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Device related sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Epididymitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Infected seroma	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Influenza	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0022 events2 affected50 at risk EG003
Invertebral discitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Localised infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peritonitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Proteus infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Septic shock	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Wound infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abscess limb	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0013 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Anal ulcer	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Breath odour	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Enterocele	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ulnar nerve injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastrostomy failure	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0012 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dementia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypotonia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Leukoencephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Monoparesis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vertebral artery stenosis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Basal ganglia stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Embolic cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Orthostatic intolerance	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0015 events4 affected156 at risk EG0020 events0 affected50 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tongue neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Device malfunction	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Device occlusion	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Granuloma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Necrosis	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral swelling	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Stent-graft endoleak	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Device failure	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Cataract	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0022 events2 affected50 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Glaucoma	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Macular fibrosis	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vulvar dysplasia	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
C-reactive protein increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pulse absent	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ischaemic limb pain	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0022 events2 affected50 at risk EG003
Atrial septal defect acquired	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Extradural abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Listeria sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Pyrexia	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0022 events2 affected50 at risk EG003
Cardiac death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0022 events1 affected50 at risk EG003
Troponin increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Brain abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Wound abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00013 events11 affected309 at risk EG0017 events6 affected156 at risk EG0023 events3 affected50 at risk EG0031 events1 affected13 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00013 events12 affected309 at risk EG0012 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0013 events3 affected156 at risk EG0020 events0 affected50 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0015 events5 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00022 events18 affected309 at risk EG0016 events6 affected156 at risk EG0023 events3 affected50 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events10 affected309 at risk EG00111 events11 affected156 at risk EG0022 events2 affected50 at risk EG003
Haematoma	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0012 events2 affected156 at risk EG0022 events2 affected50 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected309 at risk EG0013 events3 affected156 at risk EG0022 events2 affected50 at risk EG003
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Arterial spasm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Femoral artery dissection	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Aortic arteriosclerosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Poor peripheral circulation	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vasospasm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Angiodysplasia	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00016 events16 affected309 at risk EG00110 events9 affected156 at risk EG0022 events2 affected50 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Eye injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Fat embolism	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Oedema peripheral	General disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events12 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events6 affected309 at risk EG0014 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Catheter site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Fatigue	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral swelling	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Chest discomfort	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Disuse syndrome	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Puncture site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Adverse drug reaction	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Chills	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pyrexia	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Thirst	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0022 events2 affected50 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Anal stenosis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Duodenal polyp	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tooth disorder	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Bronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Sinusitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events3 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0013 events3 affected156 at risk EG0021 events1 affected50 at risk EG003
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0013 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Localised infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Ear infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Epididymitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Fungal infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Herpes simplex	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Otitis externa	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Sinobronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cystitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Folliculitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0021 events1 affected50 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0014 events4 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Parkinsonism	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Sciatica	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Autonomic neuropathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cerebellar atrophy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dementia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dyskinesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Periventricular leukomalacia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pseudoradicular syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Radiculitis lumbosacral	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Syncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Facial paresis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Myoclonus	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Radiculitis cerival	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected309 at risk EG0014 events4 affected156 at risk EG0021 events1 affected50 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0013 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Nocturnal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected309 at risk EG0012 events2 affected156 at risk EG0021 events1 affected50 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Palpitations	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events2 affected156 at risk EG0020 events0 affected50 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events5 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pityriasis	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Mediastinum neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Paget's disease of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cataract	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vision blurred	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0014 events4 affected156 at risk EG0020 events0 affected50 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Presbyacusis	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Blood glucose abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal bruit	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Blood urine present	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0012 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
International normalised ratio increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Occult blood	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Weight decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Breast tenderness	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Prostatism	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Hyperparathyroidism secondary	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Delirium	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Joint prosthesis user	Social circumstances	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Secondary hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Sinus tarsi syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Catheter site pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Device breakage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Influenza	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Ankle brachial index decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Blood pressure increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0011 events1 affected156 at risk EG0020 events0 affected50 at risk EG003
Catheter site infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Infected bunion	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Vulval abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Drug intolerance	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Gait disturbance	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Vascular dementia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0021 events1 affected50 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Staphylococcus test positive	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Nodule	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003
Leukocytosis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected309 at risk EG0010 events0 affected156 at risk EG0020 events0 affected50 at risk EG003

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
BG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
BG002	Long Lesion Substudy	Long Lesion Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
BG003	PK Substudy	PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
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	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	58	309	243	309	186	309
EG001	Zilver PTX Stent Implantation	Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	28	156	126	156	91	156
EG002	Long Lesion Substudy	To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.	13	50	40	50	27	50
EG003	PK Substudy	To evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.	6	13	13	13	11	13