Safety and Efficacy Continued Access Study of the Medtron... | NCT01531374

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)

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

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 Death 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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High Risk: Subject must have co-morbidities 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.

OR

Extreme Risk: Subject must have co-morbidities 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.
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 MCS TAVI procedure including bare metal and drug eluting stents.
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 GI bleeding that would preclude anticoagulation.
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
- Aspirin
- Heparin (HIT/HITTS) and bivalirudin
- 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.

Anatomical
High Risk:Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging (until 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)

OR

Extreme Risk: Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging. (High risk and extreme risk upon 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)
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.
Echocardiographic evidence of new or untreated 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 aortic 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 (Extreme Risk only until 23 mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort).
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
University of Southern California University Hospital

PubMed Identifier	Type	Citation	Retractions
40175015	Derived	Yakubov SJ, Van Mieghem NM, Oh JK, Ito S, Grubb KJ, O'Hair D, Forrest JK, Gada H, Mumtaz M, Deeb GM, Tang GHL, Rovin JD, Jain R, Windecker S, Skelding KA, Kleiman NS, Chetcuti SJ, Dedrick A, Boatman SV, Popma JJ, Reardon MJ. Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at >/= Intermediate Risk. J Am Coll Cardiol. 2025 Apr 8;85(13):1419-1430. doi: 10.1016/j.jacc.2025.02.009. Epub 2025 Mar 9.
38710669

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

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00083.5± 8.1 BG00181.9± 8.2 BG00283.6± 7.1 BG003

Sex: Female, Male

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

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000568 BG001185 BG002

Ethnicity (NIH/OMB)

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

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00037 BG0014 BG002

Body Surface Area

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

Mean

Standard Deviation

m^2

Title

Denominators

Categories

Title	Measurements
	BG0001.9± 0.3 BG0011.8± 0.3

New York Heart Association (NYHA) Classification

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.

Number

participants

Title

Denominators

Categories

NYHA Classification I

Title	Measurements
	BG0000 BG001

Society of Thoracic Surgeons (STS) Risk Score

The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk.

Mean

Standard Deviation

Percent of predicted mortality

Title

Denominators

Categories

Title	Measurements
	BG0009.1± 5.1 BG001

Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE)

The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk.

Mean

Standard Deviation

Percent of predicted mortality

Title

Denominators

Categories

Title	Measurements
	BG00024.2± 17.1 BG001

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

Units	Counts
Participants	OG0001257 OG001367 OG0021108

Title

Denominators

Categories

Title	Measurements
	OG00022.5 OG00130.8 OG00217.8

Secondary

Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)

MACCE is defined as a composite of:

All-Cause Death
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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

Units

Secondary

Change From Baseline in NYHA Class

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

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

Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

Secondary

Change From Baseline 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

Baseline to 30 days, baseline to 1 year

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

Secondary

Ratio of Days Alive Out of Hospital at 365 Days Post Procedure 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: Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG001	Extreme Risk: Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG002	High Risk	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts

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. The 2-5 year outcome data will be reported once data set is complete.

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

Secondary

Echocardiographic Assessment of Valve Performance

Using the following measure:

• Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.

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

Posted

Mean

Standard Deviation

cm^2

30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

ID	Title	Description
OG000	Extreme Risk: Implanted Cohort	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG001	High Risk: Implanted Cohort	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts
Participants

Secondary

Echocardiographic Assessment of Valve Performance

Using the following measure:

• Transvalvular Mean Gradient analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.

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

Posted

Mean

Standard Deviation

mmHg

30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

ID	Title	Description
OG000	Extreme Risk: Implanted Cohort	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG001	High Risk: Implanted Cohort	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts
Participants

Secondary

Echocardiographic Assessment of Valve Performance

Using the following measure:

- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.

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

Posted

Number

percentage of participants

30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

ID	Title	Description
OG000	Extreme Risk: Implanted Cohort	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG001	High Risk: Implanted Cohort	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts
Participants

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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

Units	Counts

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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

Units	Counts

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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

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

Units	Counts
Participants

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

Units	Counts
Participants

Secondary

Device Success

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

Secondary

Procedural Success

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

Participant Population = Consisted of all subjects with an 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: Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG001	Extreme Risk: Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
OG002	High Risk	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Secondary

Prosthetic Valve Dysfunction (PVD)

PVD was defined according to VARC using the site reported 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 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

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

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia Deficiencies	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0013 events3 affected367 at risk EG0026 events6 affected1,108 at risk
Anaemias Due To Chronic Disorders	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0013 events3 affected367 at risk EG0022 events2 affected1,108 at risk
Anaemias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG000420 events340 affected1,257 at risk EG001182 events150 affected367 at risk EG002319 events265 affected1,108 at risk
Coagulopathies	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0016 events6 affected367 at risk EG0026 events6 affected1,108 at risk
Haemolyses	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Leukocytoses	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0014 events4 affected367 at risk EG00213 events13 affected1,108 at risk
Lymphatic System Disorders	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Marrow Depression And Hypoplastic Anaemias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0017 events4 affected367 at risk EG0022 events2 affected1,108 at risk
Spleen Disorders	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Thrombocytopenias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00034 events34 affected1,257 at risk EG00117 events17 affected367 at risk EG00221 events20 affected1,108 at risk
Aortic Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000153 events143 affected1,257 at risk EG00129 events26 affected367 at risk EG002108 events103 affected1,108 at risk
Cardiac Conduction Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000311 events293 affected1,257 at risk EG00166 events63 affected367 at risk EG002296 events277 affected1,108 at risk
Cardiac Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected1,257 at risk EG0015 events5 affected367 at risk EG00213 events13 affected1,108 at risk
Cardiac Signs And Symptoms	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events3 affected1,108 at risk
Cardiac Valve Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Cardiomyopathies	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00016 events16 affected1,257 at risk EG0013 events3 affected367 at risk EG0027 events6 affected1,108 at risk
Coronary Artery Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00028 events26 affected1,257 at risk EG0018 events7 affected367 at risk EG00211 events10 affected1,108 at risk
Heart Failures	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000531 events329 affected1,257 at risk EG001147 events105 affected367 at risk EG002346 events248 affected1,108 at risk
Ischaemic Coronary Artery Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000102 events91 affected1,257 at risk EG00130 events26 affected367 at risk EG00297 events78 affected1,108 at risk
Left Ventricular Failures	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Mitral Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00037 events36 affected1,257 at risk EG0013 events3 affected367 at risk EG00230 events28 affected1,108 at risk
Myocardial Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0015 events5 affected367 at risk EG0029 events9 affected1,108 at risk
Pericardial Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00024 events22 affected1,257 at risk EG0019 events8 affected367 at risk EG00233 events30 affected1,108 at risk
Pulmonary Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Rate And Rhythm Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00077 events75 affected1,257 at risk EG00121 events20 affected367 at risk EG00254 events50 affected1,108 at risk
Right Ventricular Failures	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0024 events4 affected1,108 at risk
Supraventricular Arrhythmias	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000184 events152 affected1,257 at risk EG00155 events47 affected367 at risk EG002137 events119 affected1,108 at risk
Tricuspid Valvular Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events5 affected1,108 at risk
Ventricular Arrhythmias And Cardiac Arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000150 events139 affected1,257 at risk EG00149 events43 affected367 at risk EG002113 events104 affected1,108 at risk
Cardiac Malpositions Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Cardiac Septal Defects Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events3 affected1,108 at risk
Cardiovascular Disorders Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Male Reproductive Tract Disorders Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Vascular Anomalies Congenital	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Eustachian Tube Disorders	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
External Ear Disorders	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Inner Ear Signs And Symptoms	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0013 events3 affected367 at risk EG0022 events2 affected1,108 at risk
Middle Ear Disorders	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Thyroid Disorders	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Thyroid Hyperfunction Disorders	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Thyroid Hypofunction Disorders	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Blindness (Excl Colour Blindness)	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Cataract Conditions	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected1,257 at risk EG0010 events0 affected367 at risk EG0026 events6 affected1,108 at risk
Conjunctival And Corneal Bleeding And Vascular Disorders	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Corneal Structural Change, Deposit And Degeneration	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Lens Structural Change, Deposit And Degeneration (Excl Cataracts)	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Lid, Lash And Lacrimal Structural Disorders	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Ocular Bleeding And Vascular Disorders	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events2 affected1,108 at risk
Partial Vision Loss	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Retinal Bleeding And Vascular Disorders (Excl Retinopathy)	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Retinal Structural Change, Deposit And Degeneration	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Retinal, Choroid And Vitreous Infections And Inflammations	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Visual Disorders	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0012 events2 affected367 at risk EG0023 events3 affected1,108 at risk
Abdominal Findings Abnormal	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Abdominal Hernias, Site Unspecified	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Abdominal Wall Conditions	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Acute And Chronic Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Anal And Rectal Pains	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Benign Neoplasms Gastrointestinal (Excl Oral Cavity)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Colitis (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected1,257 at risk EG0013 events3 affected367 at risk EG0024 events4 affected1,108 at risk
Dental And Periodontal Infections And Inflammations	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Dental Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Diaphragmatic Hernias	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Diarrhoea (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0012 events2 affected367 at risk EG0025 events5 affected1,108 at risk
Diverticula	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0012 events2 affected367 at risk EG0024 events4 affected1,108 at risk
Duodenal And Small Intestinal Stenosis And Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0011 events1 affected367 at risk EG0027 events5 affected1,108 at risk
Duodenal Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Dyspeptic Signs And Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Faecal Abnormalities	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0029 events9 affected1,108 at risk
Flatulence, Bloating And Distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Gastric And Oesophageal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Gastric Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Gastritis (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0013 events3 affected367 at risk EG0022 events2 affected1,108 at risk
Gastrointestinal And Abdominal Pains (Excl Oral And Throat)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00019 events17 affected1,257 at risk EG0014 events4 affected367 at risk EG00215 events14 affected1,108 at risk
Gastrointestinal Atonic And Hypomotility Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00015 events14 affected1,257 at risk EG0010 events0 affected367 at risk EG0027 events6 affected1,108 at risk
Gastrointestinal Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Gastrointestinal Dyskinetic Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Gastrointestinal Fistulae	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Gastrointestinal Inflammatory Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Gastrointestinal Signs And Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00035 events35 affected1,257 at risk EG00113 events12 affected367 at risk EG00217 events16 affected1,108 at risk
Gastrointestinal Stenosis And Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0012 events2 affected367 at risk EG0027 events7 affected1,108 at risk
Gastrointestinal Ulcers And Perforation, Site Unspecified	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Gastrointestinal Vascular Occlusion And Infarction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0012 events2 affected367 at risk EG0026 events6 affected1,108 at risk
Gingival Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Inguinal Hernias	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected1,257 at risk EG0012 events2 affected367 at risk EG0025 events5 affected1,108 at risk
Intestinal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 events9 affected1,257 at risk EG0013 events3 affected367 at risk EG0029 events9 affected1,108 at risk
Intestinal Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events1 affected1,108 at risk
Large Intestinal Stenosis And Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Nausea And Vomiting Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected1,257 at risk EG0018 events6 affected367 at risk EG00212 events12 affected1,108 at risk
Non-Site Specific Gastrointestinal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG000121 events98 affected1,257 at risk EG00135 events26 affected367 at risk EG00284 events71 affected1,108 at risk
Oesophageal Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Oesophageal Stenosis And Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events1 affected1,108 at risk
Oesophageal Ulcers And Perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Oesophagitis (Excl Infective)	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Peritoneal And Retroperitoneal Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0012 events2 affected367 at risk EG0024 events4 affected1,108 at risk
Peritoneal And Retroperitoneal Haemorrhages	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0011 events1 affected367 at risk EG0029 events9 affected1,108 at risk
Tongue Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Umbilical Hernias	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Administration Site Reactions	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Asthenic Conditions	General disorders	MedDRA 14.1	Systematic Assessment	EG00033 events31 affected1,257 at risk EG00110 events8 affected367 at risk EG00225 events23 affected1,108 at risk
Body Temperature Altered	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Complications Associated With Device	General disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0011 events1 affected367 at risk EG0029 events7 affected1,108 at risk
Death And Sudden Death	General disorders	MedDRA 14.1	Systematic Assessment	EG00049 events49 affected1,257 at risk EG00118 events18 affected367 at risk EG00238 events38 affected1,108 at risk
Device Issues	General disorders	MedDRA 14.1	Systematic Assessment	EG000140 events130 affected1,257 at risk EG00119 events17 affected367 at risk EG002103 events93 affected1,108 at risk
Device Malfunction Events	General disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0012 events2 affected367 at risk EG0027 events7 affected1,108 at risk
Device Physical Property And Chemical Issues	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Febrile Disorders	General disorders	MedDRA 14.1	Systematic Assessment	EG00024 events24 affected1,257 at risk EG0015 events5 affected367 at risk EG00215 events15 affected1,108 at risk
Gait Disturbances	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
General Signs And Symptoms	General disorders	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected1,257 at risk EG0014 events4 affected367 at risk EG00211 events11 affected1,108 at risk
Healing Abnormal	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Hernias	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Implant And Catheter Site Reactions	General disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected1,257 at risk EG0012 events1 affected367 at risk EG0029 events9 affected1,108 at risk
Inflammations	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0025 events5 affected1,108 at risk
Injection Site Reactions	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Mucosal Findings Abnormal	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG00032 events31 affected1,257 at risk EG0018 events7 affected367 at risk EG00217 events15 affected1,108 at risk
Pain And Discomfort	General disorders	MedDRA 14.1	Systematic Assessment	EG00085 events67 affected1,257 at risk EG00118 events14 affected367 at risk EG00241 events40 affected1,108 at risk
Product Physical Issues	General disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Therapeutic And Nontherapeutic Responses	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0023 events3 affected1,108 at risk
Ulcers	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Vascular Complications Associated With Device	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Bile Duct Infections And Inflammations	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Cholecystitis And Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected1,257 at risk EG0014 events4 affected367 at risk EG0027 events7 affected1,108 at risk
Cholestasis And Jaundice	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Gallbladder Disorders	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Hepatic And Hepatobiliary Disorders	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0021 events1 affected1,108 at risk
Hepatic Failure And Associated Disorders	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0010 events0 affected367 at risk EG0025 events5 affected1,108 at risk
Hepatic Fibrosis And Cirrhosis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Hepatic Vascular Disorders	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Hepatobiliary Signs And Symptoms	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Hepatocellular Damage And Hepatitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events5 affected1,108 at risk
Obstructive Bile Duct Disorders (Excl Neoplasms)	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0013 events3 affected367 at risk EG0021 events1 affected1,108 at risk
Acute And Chronic Sarcoidosis	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Allergic Conditions	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Allergies To Foods, Food Additives, Drugs And Other Chemicals	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Abdominal And Gastrointestinal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00014 events14 affected1,257 at risk EG0012 events2 affected367 at risk EG0029 events9 affected1,108 at risk
Aspergillus Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Atypical Mycobacterial Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Bacterial Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00066 events54 affected1,257 at risk EG00122 events17 affected367 at risk EG00242 events37 affected1,108 at risk
Bone And Joint Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected1,257 at risk EG0012 events2 affected367 at risk EG0027 events7 affected1,108 at risk
Candida Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0021 events1 affected1,108 at risk
Cardiac Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00016 events15 affected1,257 at risk EG0015 events5 affected367 at risk EG00210 events10 affected1,108 at risk
Clostridia Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00023 events19 affected1,257 at risk EG00112 events9 affected367 at risk EG00213 events11 affected1,108 at risk
Dental And Oral Soft Tissue Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events3 affected1,108 at risk
Ear Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Enterobacter Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Enterococcal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0024 events3 affected1,108 at risk
Escherichia Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Eye And Eyelid Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Fungal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Haemophilus Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Helicobacter Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Hepatobiliary And Spleen Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Herpes Viral Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0010 events0 affected367 at risk EG0025 events5 affected1,108 at risk
Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00030 events28 affected1,257 at risk EG0018 events8 affected367 at risk EG00222 events20 affected1,108 at risk
Infectious Disorders Carrier	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Infectious Transmissions	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Influenza Viral Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00014 events14 affected1,257 at risk EG0012 events2 affected367 at risk EG00212 events11 affected1,108 at risk
Klebsiella Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0012 events2 affected367 at risk EG0023 events3 affected1,108 at risk
Lower Respiratory Tract And Lung Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000218 events170 affected1,257 at risk EG00173 events61 affected367 at risk EG002116 events101 affected1,108 at risk
Male Reproductive Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events1 affected1,108 at risk
Pseudomonal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Respiratory Syncytial Viral Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Salmonella Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Sepsis, Bacteraemia, Viraemia And Fungaemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000133 events113 affected1,257 at risk EG00137 events35 affected367 at risk EG00287 events82 affected1,108 at risk
Skin Structures And Soft Tissue Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Staphylococcal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00017 events15 affected1,257 at risk EG0015 events4 affected367 at risk EG0028 events8 affected1,108 at risk
Streptococcal Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0025 events5 affected1,108 at risk
Upper Respiratory Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected1,257 at risk EG0010 events0 affected367 at risk EG0027 events7 affected1,108 at risk
Urinary Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000132 events112 affected1,257 at risk EG00132 events25 affected367 at risk EG00267 events58 affected1,108 at risk
Vascular Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Viral Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0013 events3 affected367 at risk EG0022 events2 affected1,108 at risk
Abdominal Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Cardiac And Vascular Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00038 events37 affected1,257 at risk EG0017 events7 affected367 at risk EG00227 events27 affected1,108 at risk
Cardiovascular Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0013 events3 affected367 at risk EG0023 events3 affected1,108 at risk
Cerebral Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00017 events16 affected1,257 at risk EG0015 events4 affected367 at risk EG00213 events11 affected1,108 at risk
Chest And Lung Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Ear Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Eye Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Gastrointestinal And Hepatobiliary Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Limb Injuries (Incl Traumatic Amputation)	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events5 affected1,108 at risk
Lower Limb Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00073 events69 affected1,257 at risk EG0019 events9 affected367 at risk EG00228 events28 affected1,108 at risk
Muscle, Tendon And Ligament Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Nerve Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Neurological And Psychiatric Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Non-Site Specific Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00067 events63 affected1,257 at risk EG00116 events16 affected367 at risk EG00251 events48 affected1,108 at risk
Non-Site Specific Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00082 events78 affected1,257 at risk EG00129 events25 affected367 at risk EG00254 events52 affected1,108 at risk
Overdoses	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Pelvic Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Poisoning And Toxicity	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0013 events3 affected367 at risk EG0025 events5 affected1,108 at risk
Renal And Urinary Tract Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Respiratory Tract And Thoracic Cavity Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Site Specific Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events5 affected1,108 at risk
Skin Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00024 events21 affected1,257 at risk EG0018 events6 affected367 at risk EG00213 events12 affected1,108 at risk
Skull Fractures, Facial Bone Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Spinal Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00018 events18 affected1,257 at risk EG0011 events1 affected367 at risk EG0029 events7 affected1,108 at risk
Thermal Burns	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Thoracic Cage Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0011 events1 affected367 at risk EG0023 events3 affected1,108 at risk
Transfusion Related Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Upper Limb Fractures And Dislocations	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00013 events11 affected1,257 at risk EG0013 events3 affected367 at risk EG00214 events12 affected1,108 at risk
Urinary Tract Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Blood Counts	Investigations	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Blood Gas And Acid Base Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0017 events7 affected367 at risk EG0021 events1 affected1,108 at risk
Carbohydrate Tolerance Analyses (Incl Diabetes)	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0027 events7 affected1,108 at risk
Cardiac Function Diagnostic Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG00016 events16 affected1,257 at risk EG0014 events4 affected367 at risk EG00217 events17 affected1,108 at risk
Coagulation And Bleeding Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00022 events22 affected1,257 at risk EG0016 events6 affected367 at risk EG00217 events14 affected1,108 at risk
Ecg Investigations	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0013 events3 affected367 at risk EG0021 events1 affected1,108 at risk
Faecal Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Heart Rate And Pulse Investigations	Investigations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Hepatobiliary Histopathology Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Liver Function Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0012 events2 affected367 at risk EG0021 events1 affected1,108 at risk
Metabolism Tests	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Mineral And Electrolyte Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events3 affected1,108 at risk
Musculoskeletal And Soft Tissue Histopathology Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Physical Examination Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Platelet Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Protein Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Red Blood Cell Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected1,257 at risk EG0015 events5 affected367 at risk EG0029 events8 affected1,108 at risk
Renal Function Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events5 affected1,108 at risk
Respiratory And Pulmonary Function Diagnostic Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Respiratory Tract And Thoracic Imaging Procedures	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Skeletal And Cardiac Muscle Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 events9 affected1,257 at risk EG0013 events3 affected367 at risk EG0025 events5 affected1,108 at risk
Urinalysis	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Urinary Tract Function Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0012 events2 affected367 at risk EG0025 events5 affected1,108 at risk
Vascular Auscultatory Investigations	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Vascular Tests (Incl Blood Pressure)	Investigations	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
White Blood Cell Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Appetite Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Calcium Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0023 events3 affected1,108 at risk
Chloride Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Diabetes Mellitus (Incl Subtypes)	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0013 events2 affected367 at risk EG0024 events4 affected1,108 at risk
Diabetic Complications	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Disorders Of Purine Metabolism	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected1,257 at risk EG0010 events0 affected367 at risk EG0029 events8 affected1,108 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00012 events12 affected1,257 at risk EG0013 events3 affected367 at risk EG0024 events4 affected1,108 at risk
General Nutritional Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00032 events31 affected1,257 at risk EG00112 events12 affected367 at risk EG00210 events10 affected1,108 at risk
Hyperglycaemic Conditions	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00020 events18 affected1,257 at risk EG0018 events8 affected367 at risk EG00215 events15 affected1,108 at risk
Hypoglycaemic Conditions	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected1,257 at risk EG00110 events9 affected367 at risk EG0028 events8 affected1,108 at risk
Magnesium Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0013 events3 affected367 at risk EG0022 events2 affected1,108 at risk
Metabolic Acidoses (Excl Diabetic Acidoses)	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0012 events2 affected367 at risk EG0024 events4 affected1,108 at risk
Metabolic Alkaloses	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Mixed Acid-Base Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0023 events3 affected1,108 at risk
Phosphorus Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Potassium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00037 events34 affected1,257 at risk EG00112 events10 affected367 at risk EG00226 events25 affected1,108 at risk
Protein Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Sodium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00023 events21 affected1,257 at risk EG0012 events2 affected367 at risk EG00223 events20 affected1,108 at risk
Total Fluid Volume Decreased	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00037 events37 affected1,257 at risk EG00114 events13 affected367 at risk EG00230 events29 affected1,108 at risk
Total Fluid Volume Increased	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00036 events35 affected1,257 at risk EG00110 events10 affected367 at risk EG00223 events23 affected1,108 at risk
Arthropathies	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events3 affected1,108 at risk
Bone Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Bursal Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Connective Tissue Disorders (Excl Le)	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Crystal Arthropathic Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Extremity Deformities	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Joint Related Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Joint Related Signs And Symptoms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected1,257 at risk EG0013 events3 affected367 at risk EG0029 events9 affected1,108 at risk
Muscle Infections And Inflammations	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Muscle Pains	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Muscle Related Signs And Symptoms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Muscle Weakness Conditions	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected1,257 at risk EG0014 events4 affected367 at risk EG0025 events5 affected1,108 at risk
Musculoskeletal And Connective Tissue Pain And Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00043 events38 affected1,257 at risk EG0018 events8 affected367 at risk EG00225 events23 affected1,108 at risk
Musculoskeletal And Connective Tissue Signs And Symptoms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Myopathies	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0012 events2 affected367 at risk EG0023 events3 affected1,108 at risk
Osteoarthropathies	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 events6 affected1,257 at risk EG0011 events1 affected367 at risk EG00215 events13 affected1,108 at risk
Rheumatoid Arthropathies	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Soft Tissue Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events3 affected1,108 at risk
Spine And Neck Deformities	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Tendon Disorders	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
B-Cell Lymphomas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Bile Duct Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Bladder Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Bone Neoplasms Malignant (Excl Sarcomas)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Breast And Nipple Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Burkitt's Lymphomas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Cardiovascular Neoplasms Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Central Nervous System Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Colonic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Hepatic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Leiomyosarcomas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Leukaemias Acute Myeloid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Leukaemias Chronic Lymphocytic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Leukaemias	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Lip And Oral Cavity Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Lymphomas Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Mantle Cell Lymphomas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Metastases To Specified Sites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Multiple Myelomas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Myelodysplastic Syndromes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0013 events2 affected367 at risk EG0024 events4 affected1,108 at risk
Myeloproliferative Disorders (Excl Leukaemias)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Neoplasms Malignant Site Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0013 events3 affected367 at risk EG0026 events6 affected1,108 at risk
Nervous System Neoplasms Unspecified Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Non-Small Cell Neoplasms Malignant Of The Respiratory Tract Cell Type Specified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Oesophageal Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Oncologic Complications And Emergencies	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0012 events2 affected367 at risk EG0023 events3 affected1,108 at risk
Prostatic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Rectal Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Renal Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected1,257 at risk EG0017 events7 affected367 at risk EG0022 events2 affected1,108 at risk
Skin Melanomas (Excl Ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Skin Neoplasms Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Skin Neoplasms Malignant And Unspecified (Excl Melanoma)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events3 affected1,108 at risk
Small Intestinal Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Soft Tissue Sarcomas Histology Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Thyroid Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Urinary Tract Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Uterine Neoplasms Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Uterine Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Vulval Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Acute Polyneuropathies	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Alzheimer's Disease (Incl Subtypes)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Autonomic Nervous System Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Central Nervous System Aneurysms	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Central Nervous System Haemorrhages And Cerebrovascular Accidents	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG000105 events98 affected1,257 at risk EG00133 events30 affected367 at risk EG00286 events79 affected1,108 at risk
Central Nervous System Vascular Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected1,257 at risk EG0013 events2 affected367 at risk EG0027 events7 affected1,108 at risk
Cerebellar Coordination And Balance Disturbances	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Coma States	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Cortical Dysfunction	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Dementia (Excl Alzheimer's Type)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0010 events0 affected367 at risk EG0025 events5 affected1,108 at risk
Disturbances In Consciousness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00046 events42 affected1,257 at risk EG00114 events13 affected367 at risk EG00233 events32 affected1,108 at risk
Dyskinesias And Movement Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Encephalopathies	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00029 events27 affected1,257 at risk EG0018 events8 affected367 at risk EG00213 events13 affected1,108 at risk
Encephalopathies Toxic And Metabolic	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00022 events22 affected1,257 at risk EG0011 events1 affected367 at risk EG00214 events14 affected1,108 at risk
Facial Cranial Nerve Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Generalised Tonic-Clonic Seizures	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Headaches	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected1,257 at risk EG0011 events1 affected367 at risk EG0029 events8 affected1,108 at risk
Hydrocephalic Conditions	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Lumbar Spinal Cord And Nerve Root Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Memory Loss (Excl Dementia)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Mental Impairment (Excl Dementia And Memory Loss)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Mononeuropathies	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Motor Neurone Diseases	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Multiple Sclerosis Acute And Progressive	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Myelitis (Incl Infective)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Nervous System Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Neurological Signs And Symptoms	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00034 events32 affected1,257 at risk EG0016 events6 affected367 at risk EG00219 events18 affected1,108 at risk
Neuromuscular Junction Dysfunction	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Paralysis And Paresis (Excl Cranial Nerve)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0024 events4 affected1,108 at risk
Parkinson's Disease And Parkinsonism	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Peripheral Neuropathies	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Seizures And Seizure Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00018 events12 affected1,257 at risk EG0013 events3 affected367 at risk EG0025 events5 affected1,108 at risk
Sensory Abnormalities	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0025 events5 affected1,108 at risk
Speech And Language Abnormalities	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Spinal Cord And Nerve Root Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Structural Brain Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Transient Cerebrovascular Events	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00034 events30 affected1,257 at risk EG0016 events5 affected367 at risk EG00227 events24 affected1,108 at risk
Tremor (Excl Congenital)	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Trigeminal Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Vagus Nerve Disorders	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Abnormal Behaviour	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Anxiety Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Anxiety Symptoms	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00010 events8 affected1,257 at risk EG0014 events4 affected367 at risk EG00211 events10 affected1,108 at risk
Behaviour And Socialisation Disturbances	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Bipolar Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Confusion And Disorientation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00024 events24 affected1,257 at risk EG00110 events10 affected367 at risk EG00220 events20 affected1,108 at risk
Deliria	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00014 events14 affected1,257 at risk EG0011 events1 affected367 at risk EG0029 events9 affected1,108 at risk
Delusional Symptoms	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Depressive Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0011 events1 affected367 at risk EG0024 events4 affected1,108 at risk
Disturbances In Initiating And Maintaining Sleep	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Eating Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Mental Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00064 events56 affected1,257 at risk EG00121 events19 affected367 at risk EG00229 events29 affected1,108 at risk
Panic Attacks And Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Perception Disturbances	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Psychiatric Symptoms	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Speech Articulation And Rhythm Disturbances	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Stress Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Substance-Related Disorders	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Suicidal And Self-Injurious Behaviour	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Bladder And Urethral Symptoms	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00057 events51 affected1,257 at risk EG0018 events6 affected367 at risk EG00249 events48 affected1,108 at risk
Bladder Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0024 events4 affected1,108 at risk
Genital And Urinary Tract Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Myoneurogenic Bladder Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Nephropathies And Tubular Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Renal Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Renal Failure And Impairment	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG000263 events208 affected1,257 at risk EG00194 events76 affected367 at risk EG002181 events154 affected1,108 at risk
Renal Failure Complications	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Renal Lithiasis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0027 events6 affected1,108 at risk
Renal Neoplasms	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Renal Obstructive Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Renal Vascular And Ischaemic Conditions	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0024 events4 affected1,108 at risk
Structural And Obstructive Urethral Disorders (Excl Congenital)	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0023 events3 affected1,108 at risk
Ureteric Disorders	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Urinary Abnormalities	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00033 events29 affected1,257 at risk EG0019 events9 affected367 at risk EG00236 events29 affected1,108 at risk
Urinary Tract Lithiasis (Excl Renal)	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Breast Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Cervix Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Ovarian And Fallopian Tube Cysts And Neoplasms	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Pelvis And Broad Ligament Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Penile And Scrotal Infections And Inflammations	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Penile Disorders (Excl Erection And Ejaculation)	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Prostatic Neoplasms And Hypertrophy	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Prostatic Signs, Symptoms And Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Reproductive Tract Signs And Symptoms	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Scrotal Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Testicular And Epididymal Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Vulvovaginal Disorders	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Vulvovaginal Signs And Symptoms	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Breathing Abnormalities	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG000121 events101 affected1,257 at risk EG00139 events31 affected367 at risk EG00276 events66 affected1,108 at risk
Bronchial Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events1 affected1,108 at risk
Bronchospasm And Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00094 events55 affected1,257 at risk EG00140 events26 affected367 at risk EG00242 events35 affected1,108 at risk
Conditions Associated With Abnormal Gas Exchange	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00026 events25 affected1,257 at risk EG00112 events11 affected367 at risk EG00223 events22 affected1,108 at risk
Coughing And Associated Symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00020 events18 affected1,257 at risk EG0017 events6 affected367 at risk EG0026 events6 affected1,108 at risk
Diaphragmatic Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Laryngeal And Adjacent Sites Disorders (Excl Infections And Neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Laryngeal Spasm, Oedema And Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Lower Respiratory Tract Inflammatory And Immunologic Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00037 events34 affected1,257 at risk EG0017 events6 affected367 at risk EG00215 events14 affected1,108 at risk
Lower Respiratory Tract Signs And Symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0016 events6 affected367 at risk EG0021 events1 affected1,108 at risk
Nasal Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00020 events17 affected1,257 at risk EG00112 events11 affected367 at risk EG00215 events14 affected1,108 at risk
Parenchymal Lung Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00014 events13 affected1,257 at risk EG0014 events4 affected367 at risk EG00210 events10 affected1,108 at risk
Pharyngeal Disorders (Excl Infections And Neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Pleural Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Pneumothorax And Pleural Effusions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG000137 events106 affected1,257 at risk EG00191 events70 affected367 at risk EG00292 events75 affected1,108 at risk
Pulmonary Hypertensions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0013 events3 affected367 at risk EG0029 events8 affected1,108 at risk
Pulmonary Oedemas	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00034 events31 affected1,257 at risk EG00117 events17 affected367 at risk EG00240 events35 affected1,108 at risk
Pulmonary Thrombotic And Embolic Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected1,257 at risk EG0015 events4 affected367 at risk EG00211 events11 affected1,108 at risk
Respiratory Failures (Excl Neonatal)	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG000192 events149 affected1,257 at risk EG00177 events66 affected367 at risk EG002126 events108 affected1,108 at risk
Respiratory Tract Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0013 events3 affected367 at risk EG0021 events1 affected1,108 at risk
Upper Respiratory Tract Signs And Symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Bullous Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Dermal And Epidermal Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0012 events2 affected367 at risk EG0022 events2 affected1,108 at risk
Dermatitis And Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0012 events2 affected367 at risk EG0020 events0 affected1,108 at risk
Erythemas	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Exfoliative Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Hyperkeratoses	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Nail And Nail Bed Conditions (Excl Infections And Infestations)	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Purpura And Related Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Rashes, Eruptions And Exanthems	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0011 events1 affected367 at risk EG0023 events3 affected1,108 at risk
Skin And Subcutaneous Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0011 events1 affected367 at risk EG0020 events0 affected1,108 at risk
Skin And Subcutaneous Tissue Ulcerations	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00010 events9 affected1,257 at risk EG0012 events2 affected367 at risk EG0027 events7 affected1,108 at risk
Skin Injuries And Mechanical Dermatoses	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0013 events3 affected367 at risk EG0021 events1 affected1,108 at risk
Skin Preneoplastic Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Skin Vasculitides	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Skin Vasomotor Conditions	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Arterial Therapeutic Procedures (Excl Aortic)	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Cardiac Device Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected1,257 at risk EG0012 events2 affected367 at risk EG0023 events3 affected1,108 at risk
Haematological Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Joint Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Large Intestine Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0022 events2 affected1,108 at risk
Lens Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Prostatic Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Renal Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Therapeutic Bladder Catheterisation	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG00022 events20 affected1,257 at risk EG0011 events1 affected367 at risk EG00211 events11 affected1,108 at risk
Tracheal Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Venous Therapeutic Procedures	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Accelerated And Malignant Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected1,257 at risk EG0012 events2 affected367 at risk EG00213 events13 affected1,108 at risk
Aneurysms And Dissections Non-Site Specific	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected1,257 at risk EG0012 events2 affected367 at risk EG0026 events6 affected1,108 at risk
Aortic Aneurysms And Dissections	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected1,257 at risk EG0016 events6 affected367 at risk EG0025 events5 affected1,108 at risk
Aortic Embolism And Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Aortic Necrosis And Vascular Insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0011 events1 affected367 at risk EG0021 events1 affected1,108 at risk
Arterial And Aortic Injuries	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected1,257 at risk EG0010 events0 affected367 at risk EG00211 events10 affected1,108 at risk
Arterial Inflammations	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0020 events0 affected1,108 at risk
Blood Pressure Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected1,257 at risk EG0011 events1 affected367 at risk EG0023 events3 affected1,108 at risk
Circulatory Collapse And Shock	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected1,257 at risk EG0014 events4 affected367 at risk EG0024 events4 affected1,108 at risk
Haemorrhages	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00043 events43 affected1,257 at risk EG00116 events16 affected367 at risk EG00234 events33 affected1,108 at risk
Lymphangiopathies	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events2 affected1,108 at risk
Lymphoedemas	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Non-Site Specific Embolism And Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00010 events9 affected1,257 at risk EG0014 events4 affected367 at risk EG0027 events7 affected1,108 at risk
Non-Site Specific Necrosis And Vascular Insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected1,257 at risk EG0011 events1 affected367 at risk EG0025 events4 affected1,108 at risk
Non-Site Specific Vascular Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00016 events16 affected1,257 at risk EG00110 events10 affected367 at risk EG00212 events12 affected1,108 at risk
Peripheral Aneurysms And Dissections	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00024 events24 affected1,257 at risk EG0012 events2 affected367 at risk EG00211 events11 affected1,108 at risk
Peripheral Embolism And Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected1,257 at risk EG0018 events8 affected367 at risk EG00219 events17 affected1,108 at risk
Peripheral Vascular Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected1,257 at risk EG0018 events5 affected367 at risk EG0026 events6 affected1,108 at risk
Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00037 events35 affected1,257 at risk EG00117 events16 affected367 at risk EG00244 events41 affected1,108 at risk
Phlebitis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Site Specific Necrosis And Vascular Insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk
Site Specific Vascular Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected1,257 at risk EG0011 events1 affected367 at risk EG0022 events1 affected1,108 at risk
Vascular Hypertensive Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00060 events54 affected1,257 at risk EG00123 events22 affected367 at risk EG00257 events53 affected1,108 at risk
Vascular Hypotensive Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG000157 events137 affected1,257 at risk EG00152 events50 affected367 at risk EG00293 events90 affected1,108 at risk
Vascular Malformations And Acquired Anomalies	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected1,257 at risk EG0010 events0 affected367 at risk EG0021 events1 affected1,108 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG000259 events244 affected1,257 at risk EG00196 events92 affected367 at risk EG002267 events260 affected1,108 at risk
Leukocytoses	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00088 events82 affected1,257 at risk EG00140 events38 affected367 at risk EG00281 events79 affected1,108 at risk
Thrombocytopenias	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG000182 events175 affected1,257 at risk EG00174 events70 affected367 at risk EG002223 events217 affected1,108 at risk
Cardiac Conduction Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000335 events286 affected1,257 at risk EG00165 events56 affected367 at risk EG002387 events331 affected1,108 at risk
Heart Failures	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000107 events96 affected1,257 at risk EG00131 events30 affected367 at risk EG00274 events68 affected1,108 at risk
Rate And Rhythm Disorders	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00092 events85 affected1,257 at risk EG00130 events28 affected367 at risk EG002105 events99 affected1,108 at risk
Supraventricular Arrhythmias	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000174 events153 affected1,257 at risk EG00181 events72 affected367 at risk EG002186 events159 affected1,108 at risk
Ventricular Arrhythmias And Cardiac Arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00069 events64 affected1,257 at risk EG00116 events15 affected367 at risk EG00269 events66 affected1,108 at risk
Gastrointestinal Atonic And Hypomotility Disorders	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00070 events66 affected1,257 at risk EG00127 events27 affected367 at risk EG00278 events74 affected1,108 at risk
Nausea And Vomiting Symptoms	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00061 events57 affected1,257 at risk EG00122 events19 affected367 at risk EG00251 events45 affected1,108 at risk
Asthenic Conditions	General disorders	MedDRA 14.1	Systematic Assessment	EG00063 events57 affected1,257 at risk EG00125 events23 affected367 at risk EG00244 events43 affected1,108 at risk
Febrile Disorders	General disorders	MedDRA 14.1	Systematic Assessment	EG00077 events75 affected1,257 at risk EG00125 events24 affected367 at risk EG00271 events69 affected1,108 at risk
Oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG000102 events93 affected1,257 at risk EG00117 events17 affected367 at risk EG00295 events85 affected1,108 at risk
Pain And Discomfort	General disorders	MedDRA 14.1	Systematic Assessment	EG00086 events72 affected1,257 at risk EG00129 events22 affected367 at risk EG00284 events71 affected1,108 at risk
Lower Respiratory Tract And Lung Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00075 events67 affected1,257 at risk EG00122 events22 affected367 at risk EG00258 events55 affected1,108 at risk
Urinary Tract Infections	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000182 events149 affected1,257 at risk EG00146 events45 affected367 at risk EG002164 events141 affected1,108 at risk
Non-Site Specific Injuries	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00093 events86 affected1,257 at risk EG00119 events16 affected367 at risk EG00277 events68 affected1,108 at risk
Non-Site Specific Procedural Complications	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00080 events74 affected1,257 at risk EG00127 events25 affected367 at risk EG00292 events87 affected1,108 at risk
Skeletal And Cardiac Muscle Analyses	Investigations	MedDRA 14.1	Systematic Assessment	EG00054 events52 affected1,257 at risk EG00126 events25 affected367 at risk EG00243 events42 affected1,108 at risk
Hyperglycaemic Conditions	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00034 events33 affected1,257 at risk EG00127 events27 affected367 at risk EG00246 events46 affected1,108 at risk
Magnesium Metabolism Disorders	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00025 events25 affected1,257 at risk EG00114 events12 affected367 at risk EG00265 events64 affected1,108 at risk
Potassium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00096 events84 affected1,257 at risk EG00135 events34 affected367 at risk EG00299 events87 affected1,108 at risk
Sodium Imbalance	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00068 events61 affected1,257 at risk EG00129 events28 affected367 at risk EG00263 events58 affected1,108 at risk
Total Fluid Volume Increased	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00089 events85 affected1,257 at risk EG00128 events28 affected367 at risk EG002122 events116 affected1,108 at risk
Musculoskeletal And Connective Tissue Pain And Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG000100 events89 affected1,257 at risk EG00133 events29 affected367 at risk EG002108 events99 affected1,108 at risk
Confusion And Disorientation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00059 events57 affected1,257 at risk EG00124 events24 affected367 at risk EG00269 events68 affected1,108 at risk
Bladder And Urethral Symptoms	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00035 events35 affected1,257 at risk EG00113 events13 affected367 at risk EG00260 events57 affected1,108 at risk
Renal Failure And Impairment	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG000199 events165 affected1,257 at risk EG00166 events58 affected367 at risk EG002223 events201 affected1,108 at risk
Breathing Abnormalities	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00081 events77 affected1,257 at risk EG00118 events16 affected367 at risk EG00267 events64 affected1,108 at risk
Parenchymal Lung Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00075 events72 affected1,257 at risk EG00125 events25 affected367 at risk EG00298 events94 affected1,108 at risk
Pneumothorax And Pleural Effusions	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG000146 events138 affected1,257 at risk EG00173 events64 affected367 at risk EG002187 events168 affected1,108 at risk
Pulmonary Oedemas	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00070 events68 affected1,257 at risk EG00114 events14 affected367 at risk EG00269 events67 affected1,108 at risk
Haemorrhages	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00057 events55 affected1,257 at risk EG0019 events9 affected367 at risk EG00262 events61 affected1,108 at risk
Vascular Hypertensive Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG000152 events146 affected1,257 at risk EG00158 events56 affected367 at risk EG002206 events192 affected1,108 at risk
Vascular Hypotensive Disorders	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG000162 events146 affected1,257 at risk EG00149 events45 affected367 at risk EG002131 events120 affected1,108 at risk

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: Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
BG001	Extreme Risk: Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
BG002	High Risk	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
BG003	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 Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	1,117	1,257	1,097	1,257
EG001	Extreme Risk: TAVI Non-Iliofemoral	Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	359	367	327	367
EG002	High Risk: TAVI	High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	1,004	1,108	1,001	1,108