SPIRIT IV Clinical Trial: Clinical Evaluation of the XIEN... | NCT00307047

Description Module

Label	Type	Description	Intervention Names
XIENCE V®	Experimental		Device: XIENCE V® Everolimus Eluting Coronary Stent
TAXUS™ EXPRESS2™	Active Comparator		Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Name	Type	Description	Arm Group Labels	Other Names
XIENCE V® Everolimus Eluting Coronary Stent	Device	Drug eluting stent implantation stent in the treatment of coronary artery disease.	XIENCE V®

Measure	Description	Time Frame
Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	1 year

Measure	Description	Time Frame
Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	30 days
Ischemia Driven Target Vessel Failure (TVF)

Eligibility Module

Eligibility Criteria

General Inclusion Criteria:

Subject must be at least 18 years of age
Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
Subject must agree to undergo all protocol-required follow-up procedures
Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)
Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)
If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1
Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure
Non-study percutaneous intervention for lesions in a non-target vessel involving:
Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted
Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure
Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure
Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure

General Exclusion Criteria:

Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
The subject is currently experiencing clinical symptoms consistent with AMI
Subject has current unstable arrhythmias
Subject has a known left ventricular ejection fraction (LVEF) < 30%
Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
Subject has known renal insufficiency (e.g., serum creatinine level of > 2.5 mg/dL or subject on dialysis)
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
Subject has had a significant GI or urinary bleed within the past six months
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year
Subject is already participating in another clinical study that has not yet reached its primary endpoint
Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)
Angiographic Exclusion Criteria
The target lesion(s) meets any of the following criteria:
Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)
Located within 2 mm of the origin of the LAD or LCX
Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft
Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation
Involves a side branch requiring pre-dilatation
Total occlusion (TIMI flow 0) prior to wire crossing
Excessive tortuosity proximal to or within the lesion
Extreme angulation (≥ 90º) proximal to or within the lesion
Heavy calcification
Restenotic from previous intervention
Subject has received brachytherapy in any epicardial vessel (including side branches)
The target vessel contains thrombus
Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure
Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure

Name	Affiliation	Role
Gregg W Stone	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Scottsdale Healthcare		Scottsdale	Arizona	85260	United States
Arkansas Heart Hospital

PubMed Identifier	Type	Citation	Retractions
25940520	Derived	Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
24746650

ID	Title	Description
FG000	XIENCE V®	Patients recieving the XIENCE V® stent
FG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

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

Secondary

Ischemia Driven Target Vessel Failure (TVF)

Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

Posted

Jul 2010

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002451 OG0011222

Title

Denominators

Categories

Title	Measurements
	OG0001.9 OG0013.1

Secondary

Ischemia Driven Target Vessel Failure (TVF)

Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

Posted

Jul 2010

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Failure (TVF)

Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

Posted

Jul 2010

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Failure (TVF)

Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

ITT, @ 1 yr

Posted

Jul 2010

Number

percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Failure (TVF)

Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

ITT, @ 2 years

Posted

Jul 2010

Number

percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Failure (TVF)

Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

ITT, @ 3 years

Posted

Jul 2010

Number

percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following:

positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

ITT population.

Posted

Jul 2010

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following:

positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

ITT population

Posted

Jul 2010

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following:

positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

ITT population

Posted

Jul 2010

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following:

positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

ITT population.

Posted

Jul 2010

Number

percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following:

positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

ITT population.

Posted

Jul 2010

Number

percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following:

positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

ITT population.

Posted

Jul 2010

Number

percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Revascularization (TVR)

Revascularization of a lesion within the target vessel associated with any of the following:

positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Posted

Jul 2010

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Revascularization (TVR)

Revascularization of a lesion within the target vessel associated with any of the following:

positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Posted

Jul 2010

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Revascularization (TVR)

Revascularization of a lesion within the target vessel associated with any of the following:

positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Posted

Jul 2010

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Revascularization (TVR)

Revascularization of a lesion within the target vessel associated with any of the following:

positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Posted

Jul 2010

Number

percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Revascularization (TVR)

Revascularization of a lesion within the target vessel associated with any of the following:

positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Posted

Jul 2010

Number

percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Vessel Revascularization (TVR)

Revascularization of a lesion within the target vessel associated with any of the following:

positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Posted

Jul 2010

Number

percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Posted

Jul 2010

Number

Percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Posted

Jul 2010

Number

Percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Posted

Jul 2010

Number

Percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Posted

Jul 2010

Number

Percentage of participants

1 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Posted

Jul 2010

Number

Percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Posted

Jul 2010

Number

Percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Acute Success (Clinical Device)

Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.

clinical device success is computed per lesion

Posted

Jul 2010

Number

Percent of success

Acute: At time of index procedure

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Acute Success (Clinical Procedure)

Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.

Clinical procedure success is computed per subject

Posted

Jul 2010

Number

Percentage of success

Acute: At time of index procedure

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

All Myocardial Infarction (MI)

Posted

Jul 2010

Number

Percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002451 OG001

Secondary

All MI

Posted

Jul 2010

Number

Percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002435 OG001

Secondary

All MI

Posted

Jul 2010

Number

Percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002419 OG001

Secondary

All MI

Posted

Jul 2010

Number

Percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002416 OG001

Secondary

All MI

Posted

Jul 2010

Number

Percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002388 OG001

Secondary

All MI

Posted

Jul 2010

Number

Percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002348 OG001

Secondary

All Cause Mortality

Posted

Jul 2010

Number

Percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002451 OG001

Secondary

All Cause Mortality

Posted

Jul 2010

Number

Percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002435 OG001

Secondary

All Cause Mortality

Posted

Jul 2010

Number

Percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002419 OG001

Secondary

All Cause Mortality

Posted

Jul 2010

Number

Percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002416 OG001

Secondary

All Cause Mortality

Posted

Jul 2010

Number

Percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002388 OG001

Secondary

All Cause Mortality

Posted

Jul 2010

Number

Percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002348 OG001

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Posted

Jul 2010

Number

Percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002451 OG001

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Posted

Jul 2010

Number

Percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002435 OG001

Primary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Posted

Aug 2010

Number

Percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Posted

Jul 2010

Number

Percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002419 OG001

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Posted

Jul 2010

Number

Percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002416 OG001

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Posted

Jul 2010

Number

Percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002388 OG001

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Posted

Jul 2010

Number

Percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002348 OG001

Secondary

Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

Posted

Jul 2010

Number

Percentage of participants

0-30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

Posted

Jul 2010

Number

Percentage of participants

31-393 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

Posted

Jul 2010

Number

Percentage of participants

0 -393 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

Posted

Jul 2010

Number

Percentage of participants

0-758 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

Posted

Number

Percentage of participants

0-1123 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Protocol Defined Stent Thrombosis Rate

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Posted

Jul 2010

Number

Percentage of participants

0-30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Protocol Defined Stent Thrombosis Rate

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Posted

Jul 2010

Number

Percentage of participants

31-393 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Protocol Defined Stent Thrombosis Rate

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Posted

Jul 2010

Number

Percentage of participants

0-393 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Protocol Defined Stent Thrombosis Rate

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Posted

Jul 2010

Number

Percentage of participants

0-758 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Protocol Defined Stent Thrombosis Rate

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Posted

Number

Percentage of participants

0-1123 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Cardiac Death or Target Vessel MI Rate

Posted

Number

Percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002451 OG001

Secondary

Cardiac Death or Target Vessel MI Rate

Posted

Number

Percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002435 OG001

Secondary

Cardiac Death or Target Vessel MI Rate

Posted

Number

Percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002419 OG001

Secondary

Cardiac Death or Target Vessel MI Rate

Posted

Number

Percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002416 OG001

Secondary

Cardiac Death or Target Vessel MI Rate

Posted

Number

Percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002388 OG001

Secondary

Cardiac Death or Target Vessel MI Rate

Posted

Number

Percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG0002348 OG001

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Posted

Aug 2010

Number

Percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Posted

Aug 2010

Number

Percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Posted

Aug 2010

Number

Percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Posted

Aug 2010

Number

Percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Posted

Aug 2010

Number

Percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V®	Patients recieving the XIENCE V® stent
OG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events13 affected2,436 at risk EG0017 events7 affected1,214 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0012 events2 affected1,214 at risk
Abdominal symptom	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Abscess fungal	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Abscess neck	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0012 events2 affected1,214 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events9 affected2,436 at risk EG0015 events5 affected1,214 at risk
Acute prerenal failure	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Acute respiratory distress syndrome	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Acute sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Adverse drug reaction	General disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Amnesia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00017 events17 affected2,436 at risk EG00112 events11 affected1,214 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Angina pectoris	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG000406 events304 affected2,436 at risk EG001196 events153 affected1,214 at risk
Angina unstable	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Anxiety	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0012 events2 affected1,214 at risk
Aortic aneurysm	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0014 events3 affected1,214 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Aortic dissection	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Aortic stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events1 affected1,214 at risk
Appendicitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected2,436 at risk EG0010 events0 affected1,214 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Arachnoid cyst	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arrhythmia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00070 events60 affected2,436 at risk EG00148 events43 affected1,214 at risk
Arterial bypass operation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arterial stent insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Arterial thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arteriogram coronary	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arteriosclerosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected2,436 at risk EG0011 events1 affected1,214 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events4 affected2,436 at risk EG0014 events3 affected1,214 at risk
Arthritis infective	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Arthroscopy	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Asbestosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Asthenia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Ataxia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0009 events9 affected2,436 at risk EG0014 events4 affected1,214 at risk
Atrial flutter	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0004 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00012 events12 affected2,436 at risk EG0019 events8 affected1,214 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0006 events4 affected2,436 at risk EG0010 events0 affected1,214 at risk
Bladder mass	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Bladder neoplasm surgery	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0013 events3 affected1,214 at risk
Blood creatine phosphokinase mb increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Blood creatinine increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Blood glucose flactuation	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Blood glucose increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Blood potassium decreased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Blood urine present	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Body temperature increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Brachial plexus injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Bradycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected2,436 at risk EG0011 events1 affected1,214 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Breast cellulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0012 events2 affected1,214 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Bronchitis viral	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Carcinoid tumour of the duodenum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cardiac arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cardiac death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Cardiac enzymes increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0014 events4 affected1,214 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00044 events30 affected2,436 at risk EG00119 events15 affected1,214 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cardiac perforation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cardiac stress test abnormal	Investigations	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0013 events3 affected1,214 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cardiac ventriculogram abnormal	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Carotid artery disease	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Carotid artery occlusion	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Carotid artery stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0009 events9 affected2,436 at risk EG0016 events5 affected1,214 at risk
Carotid artery stent insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Carotid endarterectomy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cataract	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Catheter site haematoma	General disorders	MedDRA (11.0)	Systematic Assessment	EG00016 events14 affected2,436 at risk EG0017 events7 affected1,214 at risk
Catheter site haemorrhage	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Catheter site infection	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Catheter site pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events1 affected1,214 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00012 events12 affected2,436 at risk EG0019 events5 affected1,214 at risk
Central line infection	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Cerebral ventricle dilatation	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00014 events14 affected2,436 at risk EG00112 events12 affected1,214 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Chemotherapy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Chest discomfort	General disorders	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected2,436 at risk EG0014 events4 affected1,214 at risk
Chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG00054 events47 affected2,436 at risk EG00129 events24 affected1,214 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0013 events3 affected1,214 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected2,436 at risk EG0014 events4 affected1,214 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00027 events22 affected2,436 at risk EG00111 events10 affected1,214 at risk
Clostridial infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Colitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0013 events3 affected1,214 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Colostomy closure	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Computerised tomogram	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Confusional state	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0010 events0 affected1,214 at risk
Conversion disorder	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Convulsion	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary artery bypass graft	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00018 events17 affected2,436 at risk EG00113 events13 affected1,214 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Coronary artery perforation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Cyst	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected2,436 at risk EG0012 events2 affected1,214 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected2,436 at risk EG0014 events3 affected1,214 at risk
Dementia alzheimer's type	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0013 events3 affected1,214 at risk
Device failure	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Diabetes mellitus poor control	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Diabetic retinal oedema	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Diabetic ulcer	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected2,436 at risk EG0012 events2 affected1,214 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Diverticulitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected2,436 at risk EG0014 events3 affected1,214 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Dizziness	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG00012 events12 affected2,436 at risk EG0016 events6 affected1,214 at risk
Drug abuse	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0011 events1 affected1,214 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00022 events20 affected2,436 at risk EG0018 events7 affected1,214 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0016 events6 affected1,214 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Enteritis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Enterococcal infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Epistaxis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Escherichia sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Facial palsy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events4 affected2,436 at risk EG0011 events1 affected1,214 at risk
Femoral artery occlusion	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0010 events0 affected1,214 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Fibrin d dimer increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Flank pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Fluid replacement	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Fracture nonunion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0016 events5 affected1,214 at risk
Gangrene	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0013 events1 affected1,214 at risk
Gastric banding	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Gastric bypass	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Gastritis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0011 events1 affected1,214 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0013 events3 affected1,214 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Gastrointestinal haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00057 events47 affected2,436 at risk EG00126 events20 affected1,214 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected2,436 at risk EG0013 events3 affected1,214 at risk
Gastrooesophagitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Gaze palsy	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Gingivitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Goitre	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Haematemesis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Haematochezia	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Haematoma	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0010 events0 affected1,214 at risk
Haematuria	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events5 affected2,436 at risk EG0013 events3 affected1,214 at risk
Haemoptysis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected2,436 at risk EG0012 events2 affected1,214 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0011 events1 affected1,214 at risk
Helicobacter gastritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hemiparesis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Hepatic enzyme increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Hernia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0012 events2 affected1,214 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hydrocele	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hyperhidrosis	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events11 affected2,436 at risk EG0014 events4 affected1,214 at risk
Hypertensive crisis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Hypoaesthesia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hypoaesthesia facial	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events4 affected2,436 at risk EG0012 events2 affected1,214 at risk
Hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events13 affected2,436 at risk EG0013 events3 affected1,214 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Iliac artery occlusion	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Impaired healing	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events1 affected1,214 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Implantable defibrillator malfunction	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Implantable defibrillator replacement	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0012 events2 affected1,214 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Infected sebaceous cyst	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Influenza	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Intermittent claudication	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Intestinal malrotation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Labile hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Laboratory test abnormal	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Labyrinthitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Liver function test abnormal	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Localised infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Lung lobectomy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG00011 events11 affected2,436 at risk EG0017 events7 affected1,214 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Malignant urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Mechanical complication of implant	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Mediastinoscopy	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Melaena	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Mental status changes	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Multi-organ failure	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0003 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00062 events58 affected2,436 at risk EG00143 events42 affected1,214 at risk
Myocardial ischemia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00049 events46 affected2,436 at risk EG00120 events18 affected1,214 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0011 events1 affected1,214 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Nephrectomy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events5 affected2,436 at risk EG0010 events0 affected1,214 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Nervous system disorder	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Non-cardiac chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG00082 events57 affected2,436 at risk EG00130 events28 affected1,214 at risk
Normochromic normocytic anemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Occipital neuralgia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Occult blood positive	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Oedema peripheral	General disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00015 events15 affected2,436 at risk EG0015 events5 affected1,214 at risk
Osteomyelitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0015 events2 affected1,214 at risk
Pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected2,436 at risk EG0013 events3 affected1,214 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Palpitations	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0013 events3 affected1,214 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events3 affected2,436 at risk EG0013 events3 affected1,214 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Paraesthesia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Parathyroid gland operation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pericardial effusion	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00010 events8 affected2,436 at risk EG0013 events2 affected1,214 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected2,436 at risk EG0011 events1 affected1,214 at risk
Peritoneal haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pharyngeal fistula	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Physiotherapy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Platelet count decreased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pleural disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00010 events9 affected2,436 at risk EG0015 events4 affected1,214 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00042 events37 affected2,436 at risk EG00126 events24 affected1,214 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Polyp	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Post procedural haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0017 events7 affected1,214 at risk
Postoperative abscess	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Postoperative wound infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Presyncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0011 events1 affected1,214 at risk
Presyncope	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Procedural hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected2,436 at risk EG0017 events7 affected1,214 at risk
Pulmonary embolism	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Pyelonephritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Pyrexia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected2,436 at risk EG0010 events0 affected1,214 at risk
Radiation associated pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Rectal haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Renal artery occlusion	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected2,436 at risk EG0012 events2 affected1,214 at risk
Renal artery stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal artery stent placement	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal dysplasia	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Renal failure	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events5 affected2,436 at risk EG0015 events5 affected1,214 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG00023 events20 affected2,436 at risk EG0013 events3 affected1,214 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal function test abnormal	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal hypertension	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Renal impairment	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal mass	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renal vessel disorder	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Renovascular hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Reperfusion injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0011 events1 affected1,214 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected2,436 at risk EG0013 events3 affected1,214 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Retroperitoneal haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected2,436 at risk EG0013 events3 affected1,214 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events2 affected1,214 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0012 events2 affected1,214 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Salivary gland mass	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Salivary gland operation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Scrotal hematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Septic shock	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0004 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0012 events1 affected1,214 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Spinal operation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Staphylococcal abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Staphylococcal infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0010 events0 affected1,214 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Stent-graft endoleak	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Subarachnoid haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Subclavian steal syndrome	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Subdural hematoma	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events2 affected2,436 at risk EG0014 events3 affected1,214 at risk
Sudden death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Surgery	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Swelling	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Syncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00017 events17 affected2,436 at risk EG0018 events7 affected1,214 at risk
Syncope vasovagal	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Thrombosis in device	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0012 events2 affected1,214 at risk
Thyroid mass	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Tooth abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Transfusion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events11 affected2,436 at risk EG0017 events7 affected1,214 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Troponin increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Ureteral stent insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Urinary retention	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected2,436 at risk EG0016 events6 affected1,214 at risk
Urosepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected2,436 at risk EG0011 events1 affected1,214 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Vascular occlusion	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00021 events21 affected2,436 at risk EG0017 events7 affected1,214 at risk
Vasospasm	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0011 events1 affected1,214 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected2,436 at risk EG0011 events1 affected1,214 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected2,436 at risk EG0010 events0 affected1,214 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events2 affected2,436 at risk EG0014 events4 affected1,214 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Weight loss poor	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected2,436 at risk EG0010 events0 affected1,214 at risk
Wound haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected2,436 at risk EG0011 events1 affected1,214 at risk

ID	Term
D003324	Coronary Artery Disease
D023903	Coronary Restenosis

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D023921	Coronary Stenosis

ID	Title	Description
BG000	XIENCE V®	Patients recieving the XIENCE V® stent
BG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	XIENCE V®	Patients recieving the XIENCE V® stent			913	2,436	762	2,436
EG001	TAXUS™ EXPRESS 2™	Patients receiving the TAXUS™ EXPRESS 2™ stent			468	1,214	407	1,214