Safety and Efficacy Study of the Medtronic CoreValve® Sys... | NCT01240902

Label	Type	Description	Intervention Names
Extreme Risk: TAVI Iliofemoral	Experimental	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Extreme Risk: TAVI Non-Iliofemoral	Experimental	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: TAVI	Experimental	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: SAVR	Active Comparator	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)	Device: Surgical Aortic Valve Replacement (SAVR)

Name	Type	Description	Arm Group Labels	Other Names
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Device	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: TAVI Iliofemoral

Measure	Description	Time Frame
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality	All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)	1 year

Measure	Description	Time Frame
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	MACCE is defined as a composite of: All Cause Mortality Myocardial infarction (MI) All Stroke Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)	30 day, 6 month, 1 year, 2 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
High Risk Surgical Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days.
Subject has senile degenerative aortic valve stenosis with: mean gradient > 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Clinical

Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.)
Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
Untreated clinically significant coronary artery disease requiring revascularization.
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
Need for emergency surgery for any reason.
Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram.
Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
Active Gastrointestinal (GI) bleeding within the past 3 months.
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
Aspirin
Heparin (HIT/HITTS)
Bivalirudin (Extreme Risk Only)
Nitinol (titanium or nickel)
Ticlopidine and clopidogrel
Contrast media
Ongoing sepsis, including active endocarditis.
Subject refuses a blood transfusion.
Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
Currently participating in an investigational drug or another device trial.
Symptomatic carotid or vertebral artery disease.
Subject has been offered surgical aortic valve replacement but declined. (High Risk Surgical Only)

Anatomical

Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging.
Pre-existing prosthetic heart valve any position.
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).
Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.
Moderate to severe mitral stenosis.
Hypertrophic obstructive cardiomyopathy.
New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Severe basal septal hypertrophy with an outflow gradient.
Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) > 70° (for femoral and left subclavian/axillary access) and > 30° (for right subclavian/axillary access).
Ascending aorta diameter > 43 mm if the aortic annulus diameter is 23-29 mm; ascending aorta diameter > 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter > 34 mm if the aortic annulus diameter is 18-20 mm.
Congenital bicuspid or unicuspid valve verified by echocardiography.
Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Vascular

- Transarterial access not able to accommodate an 18Fr sheath.

Name	Affiliation	Role
David H Adams, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Banner Good Samaritan		Phoenix	Arizona	85006	United States
Kaiser Permanente - Los Angeles Medical Center

PubMed Identifier	Type	Citation	Retractions
36515976	Derived	O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627.
34581194

ID	Title	Description
FG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
FG001	Extreme Risk: TAVI Non-Iliofemoral

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality

All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

1 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000489 OG001150 OG002391 OG003

Title

Denominators

Categories

Title	Measurements
	OG00026.0 OG00139.3 OG00214.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI < 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.	z-test, 1 sided		<0.0001		Kaplan-Meier	26.0	Standard Error of the Mean	2.0	2-Sided	95	22.3	30.1			Kaplan-Meier Event Rate Greenwood Standard Error		Superiority or Other (legacy)

Secondary

Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)

MACCE is defined as a composite of:

All Cause Mortality
Myocardial infarction (MI)
All Stroke
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR

Secondary

The Occurrence of Individual MACCE Components

Individual MACCE Components Include:

All Cause Mortality
MI
All stroke
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR

Secondary

Major Adverse Events (MAEs)

MAEs Include:

MACCE
Acute Kidney Injury
Cardiac Tamponade
Prosthetic Valve Dysfunction
Cardiogenic Shock
Valve Endocarditis
Life-Threatening, Disabling or Major Bleeding
Major Vascular Complication
Cardiac Perforation
Device Migration/Valve Embolism

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR

Secondary

Conduction Disturbance Requiring Permanent Pacemaker Implantation

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Change in NYHA Class

Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.

New York Heart Association (NYHA) Classification:

Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Mean

Standard Deviation

average classification level change

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Secondary

Change in Distance Walked During 6-Minute Walk Test (6MWT)

Change in distance walked during 6MWT from baseline

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Mean

Standard Deviation

meters

30 day, 1 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Ratio of Days Alive Out of Hospital Versus Total Days Alive

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Mean

Standard Deviation

ratio of days alive and out of hospital

1 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Quality of Life (QoL) Change

QoL summary score change from baseline using the following measures:

Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Mean

Standard Deviation

units on a scale

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002

Secondary

Echocardiographic Assessment of Valve Performance

Using the following measures:

- Effective Orifice Area (EOA)

Participant Population= Consisted of all subjects with a valve implanted.

Posted

Mean

Standard Deviation

cm^2

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Echocardiographic Assessment of Valve Performance

Using the following measures:

- Transvalvular Mean Gradient

Participant Population= Consisted of all subjects with a valve implanted.

Posted

Mean

Standard Deviation

mmHg

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Echocardiographic Assessment of Valve Performance

Using the following measure:

- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)

Participant Population= Consisted of all subjects with a valve implanted.

Posted

Number

percentage of participants

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Aortic Valve Hospitalizations

Participant Population= Consisted of all subjects with an attempted implant procedure

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Cardiovascular Deaths and Valve Related Deaths

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Strokes and Transient Ischemic Attacks (TIAs)

Strokes (of any severity) and TIAs

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants, Kaplan-Meier

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Index Procedure Related MAEs

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Number

percentage of participants

Procedure

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Units

Secondary

Length of Index Procedure Hospital Stay

Participant Population= Consisted of all subjects with an attempted implant procedure.

Posted

Mean

Standard Deviation

days

Number of days from admission to discharge

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Device Success

Medtronic CoreValve® System subjects only.

Defined as:

Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,
Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),
Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)
Only one valve implanted in the proper anatomical location

Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.

Posted

Number

percentage of participants

Number of days from admission to discharge

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI

Secondary

Procedural Success

Medtronic CoreValve® System subjects only.

Defined as device success and absence of in-hospital MACCE.

Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.

Posted

Number

percentage of participants

Number of days from admission to discharge

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Secondary

Prosthetic Valve Dysfunction (PVD)

PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:

Peak velocity >4 m/s
Mean gradient >35 mmHg
EOA < 0.8 cm2
TVIV1 / TVIV2 < 0.25

Participant Population= Consisted of all subjects with a valve implanted.

Posted

Number

percentage of participants

30 day, 6 month, 1 year, 2 year

ID	Title	Description
OG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
OG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
OG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG003

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia Deficiencies	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG0030 events0 affected357 at risk
Anaemias Due To Chronic Disorders	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Anaemias Haemolytic Immune	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Anaemias Nec	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG000170 events140 affected489 at risk EG00175 events70 affected150 at risk EG002132 events106 affected390 at risk EG003
Coagulopathies	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected489 at risk EG0012 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Eosinophilic Disorders	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Haematological Disorders	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Leukocytoses Nec	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0011 events1 affected150 at risk EG0023 events3 affected390 at risk EG003
Marrow Depression And Hypoplastic Anaemias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Thrombocytopenias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected489 at risk EG0014 events4 affected150 at risk EG0028 events8 affected390 at risk EG003
Aortic Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00045 events44 affected489 at risk EG00112 events12 affected150 at risk EG00242 events42 affected390 at risk EG003
Cardiac Conduction Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000109 events106 affected489 at risk EG00127 events24 affected150 at risk EG00285 events79 affected390 at risk EG003
Cardiac Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected489 at risk EG0013 events3 affected150 at risk EG0029 events7 affected390 at risk EG003
Cardiac Signs And Symptoms Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Cardiac Valve Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Cardiomyopathies	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0024 events4 affected390 at risk EG003
Coronary Artery Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected489 at risk EG0014 events4 affected150 at risk EG0029 events9 affected390 at risk EG003
Heart Failures Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000186 events117 affected489 at risk EG00143 events29 affected150 at risk EG00295 events69 affected390 at risk EG003
Ischaemic Coronary Artery Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00030 events28 affected489 at risk EG0018 events8 affected150 at risk EG00217 events15 affected390 at risk EG003
Mitral Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected489 at risk EG0015 events5 affected150 at risk EG0023 events3 affected390 at risk EG003
Myocardial Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Noninfectious Pericarditis	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Pericardial Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0007 events5 affected489 at risk EG0014 events4 affected150 at risk EG0025 events5 affected390 at risk EG003
Rate And Rhythm Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00029 events28 affected489 at risk EG0016 events6 affected150 at risk EG00218 events16 affected390 at risk EG003
Right Ventricular Failures	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Supraventricular Arrhythmias	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00079 events65 affected489 at risk EG00122 events17 affected150 at risk EG00246 events43 affected390 at risk EG003
Tricuspid Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0013 events3 affected150 at risk EG0020 events0 affected390 at risk EG003
Ventricular Arrhythmias And Cardiac Arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00059 events48 affected489 at risk EG00130 events26 affected150 at risk EG00229 events27 affected390 at risk EG003
Cardiac Septal Defects Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Coagulation Disorders Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Male Reproductive Tract Disorders Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Vascular Anomalies Congenital Nec	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Hearing Losses	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Ear Disorders Nec	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Inner Ear Signs And Symptoms	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Thyroid Neoplasms	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Blindness (Excl Colour Blindness)	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Cataract Conditions	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Corneal Infections, Oedemas And Inflammations	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Lacrimal Disorders	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Retinal Bleeding And Vascular Disorders (Excl Retinopathy)	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Retinal Structural Change, Deposit And Degeneration	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Retinal, Choroid And Vitreous Infections And Inflammations	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Visual Disorders Nec	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Abdominal Wall Conditions Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Acute And Chronic Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Anal And Rectal Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Benign Neoplasms Gastrointestinal (Excl Oral Cavity)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Colitis (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0012 events2 affected150 at risk EG0020 events0 affected390 at risk EG003
Diaphragmatic Hernias	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Diarrhoea (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0013 events3 affected150 at risk EG0023 events3 affected390 at risk EG003
Diverticula	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Duodenal And Small Intestinal Stenosis And Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0013 events3 affected150 at risk EG0022 events2 affected390 at risk EG003
Duodenal Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Dyspeptic Signs And Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Faecal Abnormalities Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Flatulence, Bloating And Distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastric And Oesophageal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Gastric Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastritis (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Gastrointestinal And Abdominal Pains (Excl Oral And Throat)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00015 events13 affected489 at risk EG0014 events4 affected150 at risk EG0023 events3 affected390 at risk EG003
Gastrointestinal Atonic And Hypomotility Disorders Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0024 events3 affected390 at risk EG003
Gastrointestinal Fistulae	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Gastrointestinal Disorders Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Gastrointestinal Signs And Symptoms Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00015 events15 affected489 at risk EG0017 events7 affected150 at risk EG0027 events7 affected390 at risk EG003
Gastrointestinal Spastic And Hypermotility Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastrointestinal Stenosis And Obstruction Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0011 events1 affected150 at risk EG0023 events3 affected390 at risk EG003
Gastrointestinal Ulcers And Perforation, Site Unspecified	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Gastrointestinal Vascular Occlusion And Infarction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Inguinal Hernias	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Intestinal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0011 events1 affected150 at risk EG0025 events5 affected390 at risk EG003
Intestinal Ulcers And Perforation Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Nausea And Vomiting Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0012 events1 affected150 at risk EG0025 events3 affected390 at risk EG003
Non-Site Specific Gastrointestinal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00040 events35 affected489 at risk EG00120 events18 affected150 at risk EG00229 events27 affected390 at risk EG003
Oesophageal Stenosis And Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Oesophageal Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
Oesophagitis (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Oral Soft Tissue Pain And Paraesthesia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Pancreatic Neoplasms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Peritoneal And Retroperitoneal Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected489 at risk EG0012 events2 affected150 at risk EG0020 events0 affected390 at risk EG003
Peritoneal And Retroperitoneal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Umbilical Hernias	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Administration Site Reactions Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Asthenic Conditions	General disorders	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected489 at risk EG0013 events3 affected150 at risk EG00210 events9 affected390 at risk EG003
Body Temperature Altered	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Cardiac Complications Associated With Device	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Complications Associated With Device Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Death And Sudden Death	General disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected489 at risk EG0015 events5 affected150 at risk EG0026 events6 affected390 at risk EG003
Device Issues Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG00040 events40 affected489 at risk EG0017 events7 affected150 at risk EG00230 events28 affected390 at risk EG003
Device Malfunction Events Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0025 events5 affected390 at risk EG003
Febrile Disorders	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0012 events2 affected150 at risk EG0027 events7 affected390 at risk EG003
Feelings And Sensations Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gait Disturbances	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
General Signs And Symptoms Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected489 at risk EG0012 events2 affected150 at risk EG0024 events4 affected390 at risk EG003
Healing Abnormal Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Hernias Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Implant And Catheter Site Reactions	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Inflammations	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Injection Site Reactions	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Mass Conditions Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Oedema Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected489 at risk EG0011 events1 affected150 at risk EG0027 events6 affected390 at risk EG003
Pain And Discomfort Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG00033 events26 affected489 at risk EG00111 events9 affected150 at risk EG00229 events23 affected390 at risk EG003
Product Physical Issues	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Therapeutic And Nontherapeutic Responses	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Withdrawal And Rebound Effects	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Bile Duct Infections And Inflammations	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Cholecystitis And Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0024 events4 affected390 at risk EG003
Hepatic And Hepatobiliary Disorders Nec	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Hepatic Failure And Associated Disorders	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Hepatic Fibrosis And Cirrhosis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Hepatocellular Damage And Hepatitis Nec	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Anaphylactic Responses	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Abdominal And Gastrointestinal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0008 events6 affected489 at risk EG0011 events1 affected150 at risk EG0024 events4 affected390 at risk EG003
Atypical Mycobacterial Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Bacterial Infections Nec	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00025 events22 affected489 at risk EG0016 events6 affected150 at risk EG00220 events15 affected390 at risk EG003
Bone And Joint Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Candida Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Cardiac Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Central Nervous System And Spinal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Clostridia Infections	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected489 at risk EG0012 events2 affected150 at risk EG0027 events6 affected390 at risk EG003
Ear Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Enterobacter Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Enterococcal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Escherichia Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Fungal Infections Nec	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Haemophilus Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Herpes Viral Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0012 events2 affected150 at risk EG0022 events2 affected390 at risk EG003
Infections Nec	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected489 at risk EG0012 events2 affected150 at risk EG0026 events6 affected390 at risk EG003
Infectious Transmissions	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Influenza Viral Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Klebsiella Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Lower Respiratory Tract And Lung Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00095 events74 affected489 at risk EG00126 events25 affected150 at risk EG00248 events44 affected390 at risk EG003
Pseudomonal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Sepsis, Bacteraemia, Viraemia And Fungaemia Nec	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00035 events32 affected489 at risk EG00118 events17 affected150 at risk EG00238 events32 affected390 at risk EG003
Staphylococcal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0014 events4 affected150 at risk EG0023 events3 affected390 at risk EG003
Streptococcal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0013 events3 affected150 at risk EG0022 events2 affected390 at risk EG003
Upper Respiratory Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0012 events2 affected150 at risk EG0022 events2 affected390 at risk EG003
Urinary Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00032 events28 affected489 at risk EG00111 events9 affected150 at risk EG00221 events21 affected390 at risk EG003
Vascular Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Viral Infections Nec	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Anaesthetic Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Cardiac And Vascular Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00017 events16 affected489 at risk EG0014 events3 affected150 at risk EG0027 events7 affected390 at risk EG003
Cardiovascular Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0012 events2 affected150 at risk EG0020 events0 affected390 at risk EG003
Cerebral Injuries Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0012 events2 affected150 at risk EG0025 events5 affected390 at risk EG003
Chest And Lung Injuries Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Fractures And Dislocations Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0013 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastrointestinal And Hepatobiliary Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Limb Injuries Nec (Incl Traumatic Amputation)	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Lower Limb Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00019 events18 affected489 at risk EG0011 events1 affected150 at risk EG00210 events9 affected390 at risk EG003
Non-Site Specific Injuries Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected489 at risk EG0014 events4 affected150 at risk EG00216 events14 affected390 at risk EG003
Non-Site Specific Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00027 events25 affected489 at risk EG0016 events6 affected150 at risk EG00226 events25 affected390 at risk EG003
Pelvic Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0012 events2 affected150 at risk EG0022 events2 affected390 at risk EG003
Poisoning And Toxicity	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Radiation Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Reproductive System And Breast Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Respiratory Tract And Thoracic Cavity Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Site Specific Injuries Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0023 events3 affected390 at risk EG003
Skin Injuries Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected489 at risk EG0011 events1 affected150 at risk EG0025 events5 affected390 at risk EG003
Skin Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Skull Fractures, Facial Bone Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Spinal Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected489 at risk EG0011 events1 affected150 at risk EG0028 events5 affected390 at risk EG003
Thoracic Cage Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Transfusion Related Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Upper Limb Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Bacteria Identification And Serology (Excl Mycobacteria)	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Blood Counts Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0012 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Blood Gas And Acid Base Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
Carbohydrate Tolerance Analyses (Incl Diabetes)	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Cardiac Function Diagnostic Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0013 events3 affected150 at risk EG0020 events0 affected390 at risk EG003
Coagulation And Bleeding Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0012 events2 affected150 at risk EG0026 events6 affected390 at risk EG003
Ecg Investigations	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Liver Function Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Metabolism Tests Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Microbiology And Serology Tests Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Mineral And Electrolyte Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Physical Examination Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Platelet Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Protein Analyses Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Red Blood Cell Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected489 at risk EG0014 events4 affected150 at risk EG00210 events10 affected390 at risk EG003
Renal Function Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Respiratory Tract And Thoracic Imaging Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Skeletal And Cardiac Muscle Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0012 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Tissue Enzyme Analyses Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Urinalysis Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Urinary Tract Function Analyses Nec	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0012 events2 affected150 at risk EG0020 events0 affected390 at risk EG003
Vascular Tests Nec (Incl Blood Pressure)	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
White Blood Cell Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Appetite Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Calcium Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Diabetes Mellitus (Incl Subtypes)	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Diabetic Complications Dermal	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Diabetic Complications Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Disorders Of Purine Metabolism	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Electrolyte Imbalance Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
General Nutritional Disorders Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00020 events18 affected489 at risk EG0017 events7 affected150 at risk EG0024 events4 affected390 at risk EG003
Hyperglycaemic Conditions Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0011 events1 affected150 at risk EG0023 events3 affected390 at risk EG003
Hypoglycaemic Conditions Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0015 events5 affected150 at risk EG0023 events3 affected390 at risk EG003
Magnesium Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Metabolic Acidoses (Excl Diabetic Acidoses)	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0014 events3 affected150 at risk EG0021 events1 affected390 at risk EG003
Metabolic Alkaloses	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Mixed Acid-Base Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
Potassium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00015 events14 affected489 at risk EG0012 events2 affected150 at risk EG0028 events8 affected390 at risk EG003
Protein Metabolism Disorders Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Sodium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00010 events8 affected489 at risk EG0013 events2 affected150 at risk EG0025 events5 affected390 at risk EG003
Total Fluid Volume Decreased	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00015 events15 affected489 at risk EG0018 events8 affected150 at risk EG0029 events8 affected390 at risk EG003
Total Fluid Volume Increased	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00013 events12 affected489 at risk EG0011 events1 affected150 at risk EG0027 events7 affected390 at risk EG003
Arthropathies Nec	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Bone Disorders Nec	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Bone Related Signs And Symptoms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Joint Related Signs And Symptoms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0023 events3 affected390 at risk EG003
Metabolic Bone Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Muscle Weakness Conditions	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0013 events3 affected150 at risk EG0020 events0 affected390 at risk EG003
Musculoskeletal And Connective Tissue Pain And Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected489 at risk EG0011 events1 affected150 at risk EG00215 events13 affected390 at risk EG003
Musculoskeletal And Connective Tissue Signs And Symptoms Nec	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Myopathies	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Osteoarthropathies	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0013 events2 affected150 at risk EG0024 events3 affected390 at risk EG003
Spine And Neck Deformities	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
B-Cell Lymphomas Nec	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Bladder Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Breast And Nipple Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Colonic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastric Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Gastrointestinal Neoplasms Malignancy Unspecified Nec	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Hepatic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Leukaemias Acute Myeloid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Multiple Myelomas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Myelodysplastic Syndromes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Neoplasms Malignant Site Unspecified Nec	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Neuromas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Pharyngeal And Laryngeal Neoplasms Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Prostatic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Renal Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified Nec	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0012 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Skin Neoplasms Malignant And Unspecified (Excl Melanoma)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Thyroid Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Acute Polyneuropathies	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Central Nervous System Haemorrhages And Cerebrovascular Accidents	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00028 events28 affected489 at risk EG00114 events14 affected150 at risk EG00230 events26 affected390 at risk EG003
Central Nervous System Vascular Disorders Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
Cerebellar Coordination And Balance Disturbances	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Coma States	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Cortical Dysfunction Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Dementia (Excl Alzheimer's Type)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Disturbances In Consciousness Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected489 at risk EG0015 events4 affected150 at risk EG00215 events14 affected390 at risk EG003
Dyskinesias And Movement Disorders Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Encephalopathies Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00014 events14 affected489 at risk EG0010 events0 affected150 at risk EG0024 events4 affected390 at risk EG003
Encephalopathies Toxic And Metabolic	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00011 events8 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
Headaches Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0012 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Hydrocephalic Conditions	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Increased Intracranial Pressure Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Lumbar Spinal Cord And Nerve Root Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Memory Loss (Excl Dementia)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Migraine Headaches	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Mononeuropathies	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Nervous System Disorders Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Neurological Signs And Symptoms Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected489 at risk EG0018 events8 affected150 at risk EG0022 events2 affected390 at risk EG003
Neuromuscular Junction Dysfunction	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Paralysis And Paresis (Excl Cranial Nerve)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Peripheral Neuropathies Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Seizures And Seizure Disorders Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0014 events3 affected150 at risk EG0021 events1 affected390 at risk EG003
Sensory Abnormalities Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Speech And Language Abnormalities	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Transient Cerebrovascular Events	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected489 at risk EG0011 events1 affected150 at risk EG0026 events6 affected390 at risk EG003
Tremor (Excl Congenital)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Vagus Nerve Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Anxiety Symptoms	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Behaviour And Socialisation Disturbances	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Confusion And Disorientation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected489 at risk EG0011 events1 affected150 at risk EG0029 events8 affected390 at risk EG003
Deliria	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0024 events4 affected390 at risk EG003
Depressive Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Mental Disorders Nec	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected489 at risk EG0014 events3 affected150 at risk EG0024 events4 affected390 at risk EG003
Perception Disturbances	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Suicidal And Self-Injurious Behaviour	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Bladder And Urethral Symptoms	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected489 at risk EG0019 events8 affected150 at risk EG0029 events8 affected390 at risk EG003
Bladder Disorders Nec	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0013 events3 affected150 at risk EG0020 events0 affected390 at risk EG003
Genital And Urinary Tract Disorders Nec	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Nephritis Nec	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Nephropathies And Tubular Disorders Nec	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Renal Disorders Nec	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Renal Failure And Impairment	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG000108 events90 affected489 at risk EG00143 events31 affected150 at risk EG00242 events38 affected390 at risk EG003
Renal Failure Complications	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Renal Lithiasis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Renal Obstructive Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Renal Vascular And Ischaemic Conditions	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Ureteric Disorders Nec	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Urinary Abnormalities	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00013 events10 affected489 at risk EG0011 events1 affected150 at risk EG0028 events8 affected390 at risk EG003
Breast Disorders Nec	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Pelvic Prolapse Conditions	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Prostatic Neoplasms And Hypertrophy	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Reproductive Tract Disorders Nec (Excl Neoplasms)	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Scrotal Disorders Nec	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Vulvovaginal Disorders Nec	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Breathing Abnormalities	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00027 events26 affected489 at risk EG00129 events21 affected150 at risk EG00233 events30 affected390 at risk EG003
Bronchial Conditions Nec	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Bronchospasm And Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00028 events25 affected489 at risk EG00121 events16 affected150 at risk EG00215 events13 affected390 at risk EG003
Conditions Associated With Abnormal Gas Exchange	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected489 at risk EG0011 events1 affected150 at risk EG0026 events6 affected390 at risk EG003
Coughing And Associated Symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0026 events5 affected390 at risk EG003
Diaphragmatic Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0012 events2 affected150 at risk EG0020 events0 affected390 at risk EG003
Laryngeal And Adjacent Sites Disorders Nec (Excl Infections And Neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Laryngeal Spasm, Oedema And Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Lower Respiratory Tract Inflammatory And Immunologic Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected489 at risk EG0016 events6 affected150 at risk EG0027 events7 affected390 at risk EG003
Lower Respiratory Tract Signs And Symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0012 events2 affected150 at risk EG0021 events1 affected390 at risk EG003
Nasal Disorders Nec	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected489 at risk EG0011 events1 affected150 at risk EG0025 events5 affected390 at risk EG003
Parenchymal Lung Disorders Nec	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected489 at risk EG0013 events3 affected150 at risk EG0023 events3 affected390 at risk EG003
Pharyngeal Disorders (Excl Infections And Neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Pneumothorax And Pleural Effusions Nec	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00074 events54 affected489 at risk EG00136 events26 affected150 at risk EG00239 events29 affected390 at risk EG003
Pulmonary Hypertensions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0011 events1 affected150 at risk EG0025 events5 affected390 at risk EG003
Pulmonary Oedemas	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00024 events23 affected489 at risk EG0013 events3 affected150 at risk EG0029 events9 affected390 at risk EG003
Pulmonary Thrombotic And Embolic Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Respiratory Failures (Excl Neonatal)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00062 events54 affected489 at risk EG00129 events28 affected150 at risk EG00240 events36 affected390 at risk EG003
Respiratory Tract Disorders Nec	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0023 events3 affected390 at risk EG003
Tracheal Disorders (Excl Infections And Neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Upper Respiratory Tract Signs And Symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Bullous Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Dermal And Epidermal Conditions Nec	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Dermatitis And Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Dermatitis Ascribed To Specific Agent	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Purpura And Related Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Rashes, Eruptions And Exanthems Nec	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Skin And Subcutaneous Tissue Ulcerations	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Skin Haemorrhages	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Skin Injuries And Mechanical Dermatoses	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected489 at risk EG0011 events1 affected150 at risk EG0026 events6 affected390 at risk EG003
Skin Preneoplastic Conditions Nec	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Housing Circumstances	Social circumstances	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Cardiac Device Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Corneal And Scleral Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Fracture Treatments (Excl Skull And Spine)	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Hernia Repairs	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Joint Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Lens Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0022 events2 affected390 at risk EG003
Limb Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Muscle Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Prophylactic Procedures Nec	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Renal Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0021 events1 affected390 at risk EG003
Therapeutic Procedures Nec	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected489 at risk EG0010 events0 affected150 at risk EG0023 events3 affected390 at risk EG003
Tracheal Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Ureteric Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Accelerated And Malignant Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0012 events2 affected150 at risk EG0020 events0 affected390 at risk EG003
Aneurysms And Dissections Non-Site Specific	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0015 events5 affected150 at risk EG0020 events0 affected390 at risk EG003
Aortic Aneurysms And Dissections	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected489 at risk EG0013 events3 affected150 at risk EG0021 events1 affected390 at risk EG003
Aortic Necrosis And Vascular Insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Arterial And Aortic Injuries	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Blood Pressure Disorders Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Circulatory Collapse And Shock	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected489 at risk EG0012 events2 affected150 at risk EG0022 events2 affected390 at risk EG003
Haemorrhages Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00024 events20 affected489 at risk EG00113 events13 affected150 at risk EG00219 events19 affected390 at risk EG003
Lymphangiopathies	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected489 at risk EG0010 events0 affected150 at risk EG0023 events2 affected390 at risk EG003
Lymphoedemas	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Non-Site Specific Embolism And Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected489 at risk EG0011 events1 affected150 at risk EG0021 events1 affected390 at risk EG003
Non-Site Specific Necrosis And Vascular Insufficiency Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0012 events2 affected150 at risk EG0023 events3 affected390 at risk EG003
Non-Site Specific Vascular Disorders Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0022 events2 affected390 at risk EG003
Peripheral Aneurysms And Dissections	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected489 at risk EG0010 events0 affected150 at risk EG0029 events9 affected390 at risk EG003
Peripheral Embolism And Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00022 events21 affected489 at risk EG0015 events5 affected150 at risk EG0027 events7 affected390 at risk EG003
Peripheral Vascular Disorders Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0011 events1 affected150 at risk EG0023 events2 affected390 at risk EG003
Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00018 events16 affected489 at risk EG0012 events2 affected150 at risk EG00212 events12 affected390 at risk EG003
Site Specific Vascular Disorders Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected489 at risk EG0011 events1 affected150 at risk EG0020 events0 affected390 at risk EG003
Varicose Veins Non-Site Specific	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003
Vascular Hypertensive Disorders Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected489 at risk EG0013 events3 affected150 at risk EG00215 events14 affected390 at risk EG003
Vascular Hypotensive Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00054 events52 affected489 at risk EG00115 events15 affected150 at risk EG00223 events21 affected390 at risk EG003
Vascular Malformations And Acquired Anomalies	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected489 at risk EG0010 events0 affected150 at risk EG0020 events0 affected390 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemias Nec	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00098 events90 affected489 at risk EG00128 events27 affected150 at risk EG00277 events76 affected390 at risk EG00378 events69 affected357 at risk
Leukocytoses Nec	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00042 events38 affected489 at risk EG00119 events18 affected150 at risk EG00226 events25 affected390 at risk EG003
Thrombocytopenias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00073 events68 affected489 at risk EG00133 events32 affected150 at risk EG00264 events61 affected390 at risk EG003
Cardiac Conduction Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000137 events114 affected489 at risk EG00137 events32 affected150 at risk EG002100 events80 affected390 at risk EG003
Heart Failures Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00032 events30 affected489 at risk EG0019 events9 affected150 at risk EG00222 events20 affected390 at risk EG003
Rate And Rhythm Disorders Nec	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00030 events29 affected489 at risk EG00113 events12 affected150 at risk EG00222 events21 affected390 at risk EG003
Supraventricular Arrhythmias	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00066 events60 affected489 at risk EG00142 events36 affected150 at risk EG00269 events59 affected390 at risk EG003
Ventricular Arrhythmias And Cardiac Arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00033 events31 affected489 at risk EG00110 events8 affected150 at risk EG00222 events22 affected390 at risk EG003
Gastrointestinal Atonic And Hypomotility Disorders Nec	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00037 events36 affected489 at risk EG00112 events12 affected150 at risk EG00222 events22 affected390 at risk EG003
Nausea And Vomiting Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00033 events26 affected489 at risk EG0017 events7 affected150 at risk EG00225 events23 affected390 at risk EG003
Febrile Disorders	General disorders	MedDRA 14.1	Systematic Assessment	EG00039 events36 affected489 at risk EG0018 events7 affected150 at risk EG00216 events16 affected390 at risk EG003
Oedema Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG00048 events44 affected489 at risk EG00118 events16 affected150 at risk EG00235 events34 affected390 at risk EG003
Pain And Discomfort Nec	General disorders	MedDRA 14.1	Systematic Assessment	EG00034 events30 affected489 at risk EG00110 events9 affected150 at risk EG00230 events26 affected390 at risk EG003
Lower Respiratory Tract And Lung Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00026 events26 affected489 at risk EG00116 events16 affected150 at risk EG00219 events18 affected390 at risk EG003
Urinary Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00080 events75 affected489 at risk EG00134 events28 affected150 at risk EG00259 events51 affected390 at risk EG003
Non-Site Specific Injuries Nec	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00026 events25 affected489 at risk EG0012 events2 affected150 at risk EG00223 events21 affected390 at risk EG003
Non-Site Specific Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00023 events21 affected489 at risk EG0016 events6 affected150 at risk EG00221 events20 affected390 at risk EG003
Skeletal And Cardiac Muscle Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00016 events16 affected489 at risk EG0017 events7 affected150 at risk EG00215 events15 affected390 at risk EG003
Hyperglycaemic Conditions Nec	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00022 events22 affected489 at risk EG0016 events6 affected150 at risk EG00219 events19 affected390 at risk EG003
Magnesium Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00017 events17 affected489 at risk EG00110 events9 affected150 at risk EG0026 events6 affected390 at risk EG003
Potassium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00063 events56 affected489 at risk EG00125 events16 affected150 at risk EG00238 events36 affected390 at risk EG003
Sodium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00026 events25 affected489 at risk EG00113 events10 affected150 at risk EG00222 events22 affected390 at risk EG003
Total Fluid Volume Increased	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected489 at risk EG00113 events12 affected150 at risk EG00221 events21 affected390 at risk EG003
Musculoskeletal And Connective Tissue Pain And Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00042 events34 affected489 at risk EG00119 events16 affected150 at risk EG00239 events34 affected390 at risk EG003
Neurological Signs And Symptoms Nec	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00020 events18 affected489 at risk EG0012 events2 affected150 at risk EG00222 events21 affected390 at risk EG003
Anxiety Symptoms	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00025 events25 affected489 at risk EG0016 events6 affected150 at risk EG00214 events14 affected390 at risk EG003
Confusion And Disorientation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00034 events32 affected489 at risk EG00114 events13 affected150 at risk EG00225 events24 affected390 at risk EG003
Renal Failure And Impairment	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00078 events67 affected489 at risk EG00120 events16 affected150 at risk EG00243 events40 affected390 at risk EG003
Breathing Abnormalities	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00026 events26 affected489 at risk EG0018 events8 affected150 at risk EG00229 events27 affected390 at risk EG003
Bronchospasm And Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected489 at risk EG00111 events10 affected150 at risk EG0025 events4 affected390 at risk EG003
Conditions Associated With Abnormal Gas Exchange	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 events12 affected489 at risk EG00111 events8 affected150 at risk EG00212 events11 affected390 at risk EG003
Parenchymal Lung Disorders Nec	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00035 events35 affected489 at risk EG00110 events10 affected150 at risk EG00223 events23 affected390 at risk EG003
Pneumothorax And Pleural Effusions Nec	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG00082 events76 affected489 at risk EG00132 events30 affected150 at risk EG00258 events52 affected390 at risk EG003
Pulmonary Oedemas	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00029 events29 affected489 at risk EG0015 events5 affected150 at risk EG00220 events20 affected390 at risk EG003
Haemorrhages Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00035 events34 affected489 at risk EG0014 events4 affected150 at risk EG00226 events26 affected390 at risk EG003
Vascular Hypertensive Disorders Nec	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00049 events45 affected489 at risk EG00120 events20 affected150 at risk EG00255 events46 affected390 at risk EG003
Vascular Hypotensive Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00073 events68 affected489 at risk EG00121 events18 affected150 at risk EG00241 events40 affected390 at risk EG003

ID	Term
D001024	Aortic Valve Stenosis
D006349	Heart Valve Diseases

ID	Term
D000082862	Aortic Valve Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

ID	Title	Description
BG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
BG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
BG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
BG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Extreme Risk: TAVI Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access	452	489	440	489
EG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access	142	150	139	150
EG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	346	390	355	390
EG003	High Risk: SAVR	High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)	324	357	320	357