SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial | NCT04722250

NCT04722250

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medtronic Self-Expanding TAV	Experimental	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.	Device: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
Edwards Balloon-Expandable THV	Experimental	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.	Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems	Device	TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality, Disabling Stroke or Heart Failure Rehospitalization	Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.	12 months
Bioprosthetic Valve Dysfunction (BVD)	Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))	12 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With BVD in Female Subjects	Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)).

Other Outcomes

Measure	Description	Time Frame
Device Success	Device Success is defined as meeting all of the following: Freedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s) AND No moderate or severe prosthetic valve regurgitation)

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Howard Herrmann, MD	University of Pennsylvania, United States	Principal Investigator
Roxana Mehran, MD	Mount Sinai School of Medicine, United States	Principal Investigator
Didier Tchétché, MD	Clinique Pasteur Toulouse, France	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Memorial Hospital		La Jolla	California	92037	United States
Cedars Sinai Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39382856	Derived	Tchetche D, Mehran R, Blackman DJ, Khalil RF, Mollmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Bleiziffer S, Lin L, Szerlip M, Grubb KJ, Byku I, Guerrero M, Gillam LD, Petronio AS, Attizzani GF, Batchelor WB, Gada H, Rogers T, Rovin JD, Whisenant B, Benton S, Gardner B, Padang R, Althouse AD, Herrmann HC. Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1106-1114. doi: 10.1001/jamacardio.2024.3241.
38587261

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 15, 2021	Sep 30, 2024

Arm/Group Information

ID	Title	Description
BG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
BG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00080.1± 6.3 BG00180.3± 6.1 BG00280.2± 6.2

Sex/Gender, Customized

Count of Participants

Participants

Title

Denominators

Categories

Gender Female

Title	Measurements
	BG000312 BG001309 BG002

Ethnicity (NIH/OMB)

Ethnicity and race are reported only by US sites (SEV TAV n=183; BE TAV n= 184; Total N=367) This is for as treated subjects.

**Note**: There are 8 SEV subjects and 5 BEV Subjects from US Sites who did not report ethnicity, therefore the total number with ethnicity reported are 175 SEV and 179 BEV.

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity of US Only, Unknown number also includes outside of US.

Title	Measurements
Hispanic or Latino	BG0004 BG001

Race (NIH/OMB)

Ethnicity and race are reported only by US sites (SEV TAV n=183; BE TAV n= 184; Total N=367) For as treated subjects.

**NOTE**: There are 10 SEV subjects and 5 BEV subjects from US Sites that did not report race, therefore the total subjects are 173 SEV and 179 BEV.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG001

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000183 BG001184 BG002

Body Surface Area

Mean

Standard Deviation

m^2

Title

Denominators

Categories

Title	Measurements
	BG0001.8± 0.2 BG0011.8± 0.2 BG002

STS Score

Measure Description: The Society of Thoracic Surgeons (STS) Score is a score that represents the risk of operative mortality, major morbidity, and complications for adult cardiac surgeries.

A total STS Score, presented as a risk probability on a scale of 0-100%, is calculated based on patient characteristics. The STS Score is calculated before a patient undergoes the transcatheter aortic valve replacement (TAVR) index procedure in the study, and a higher STS Score means a patient is at higher risk for surgery.

Mean

Standard Deviation

Percent

Title

Denominators

Categories

Title	Measurements
	BG0003.3± 1.9 BG001

STS Category

Patients are grouped into the following categories based on their STS score:

<3, [3,5), [5,8), ≥ 8](streamdown:incomplete-link)

Count of Participants

Participants

Title

Denominators

Categories

Count of Participants

Title	Measurements
	BG000355 BG001361

NYHA (Baseline)

New York Heart Association (NYHA) Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II:Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III:Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
NYHA I	BG0004 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

Mortality, Disabling Stroke or Heart Failure Rehospitalization

Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Number

Percent of Participants (K-M Rate)

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants	OG000355 OG001361

Title

Denominators

Categories

Title	Measurements
	OG0009.7 OG00110.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		z-test on Kaplan-Meier percentages		<0.001		Risk Difference (RD)	-1.0			2-Sided	90	-4.7	2.8					Non-Inferiority	The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.

Primary

Bioprosthetic Valve Dysfunction (BVD)

Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted). *Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.

Posted

Number

Percent of Participants (K-M Rate)

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Secondary

Percentage of Participants With BVD in Female Subjects

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) *Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.

Posted

Number

percentage of participants (K-M rate)

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Secondary

Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)

HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure.

Posted

Number

percentage of participants (K-M rate)

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts

Secondary

Hemodynamic Mean Gradient as Continuous Variable

Mean aortic gradient as measured by echocardiogram at the 12-month visit.

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)

Posted

Mean

Standard Deviation

mmHg

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Secondary

Effective Orifice Area (EOA) as a Continuous Variable

Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit.

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)

Posted

Mean

Standard Deviation

cm2

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Secondary

Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)

Moderate or severe PPM will be defined as follows:

For subjects with BMI < 30 kg/m2

Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2
Severe PPM: EOAI = ≤ 0.65 cm2/m2

For subjects with BMI ≥ 30 kg/m2

Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2
Severe PPM: EOAI = ≤ 0.55 cm2/m2

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts

Other Pre-specified

Device Success

Device Success is defined as meeting all of the following:

Freedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s) AND No moderate or severe prosthetic valve regurgitation)

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units

Other Pre-specified

Incidence of an Early Safety Composite

Incidence of an early safety composite at 30 days defined as:

All-cause mortality
All stroke (disabling and non-disabling)
Life-threatening bleeding
Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Number

percentage of participants (K-M rate)

30 days

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Other Pre-specified

Hospital Readmission Rate for Any Cause

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Number

percentage of participants (K-M rate)

30 days

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Clinical Efficacy

Incidence of clinical efficacy (after 30 days) at 12 months defined as a composite of:

All-cause mortality
All stroke (disabling and non-disabling)
Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
NYHA class III or IV
Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)

Posted

Number

percentage of participants (K-M rate)

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Other Pre-specified

Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Number

percentage of participants (K-M rate)

12 months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants	OG000

Other Pre-specified

New Pacemaker Implantation Rate

Note: This section is excluding subjects with pacemaker or ICD at baseline.

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Number

percentage of participants (K-M rate)

30 days, 12 Months, 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Other Pre-specified

Aortic Valve Re-intervention Rate

Aortic valve re-intervention rate as measured as the percentage of patients that had a procedure to fix or replace their prosthetic valve at the 30 days, 12 months and 2 Year visit.

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Number

percentage of participants (K-M rate)

30 days, 12 months, 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Other Pre-specified

6-minute Walk Test (6MWT) Change From Baseline

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Mean

Standard Deviation

Meters

30 days, 12 Months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants	OG000

Other Pre-specified

Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])

EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Mean

Standard Deviation

score on a scale

30 days, 12 Months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001

Other Pre-specified

Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]

Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Note: This is the overall summary score for KCCQ.

As Treated set (all subjects with attempted TAVR procedure according to first device used)

Posted

Mean

Standard Deviation

score on a scale

30 days, 12 Months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Other Pre-specified

Bioprosthetic Valve Dysfunction (BVD)

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).

Posted

Number

percentage of participants (K-M rate)

2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Other Pre-specified

Effective Orifice Area (EOA) as a Continuous Variable

Effective Orifice Area (EOA) as measured by echocardiogram at the following intervals: Discharge, 30 Days, 12 Months and 2 Years

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).

Posted

Mean

Standard Deviation

cm^2

Discharge, 30 Days, 12 Months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Other Pre-specified

Hemodynamic Mean Gradient as a Continuous Variable

Mean aortic gradient as measured by echocardiogram at the following intervals: Discharge, 30 Days, 12 Months and 2 Years

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).

Posted

Mean

Standard Deviation

mmHg

Discharge, 30 Days, 12 Months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Other Pre-specified

Rate of Paravalvular Leak (PVL) by Degree of Severity

Paravalvular Leak as measured by the percentage of participants that had none, trace, mild, moderate and severe, at Discharge, 30 Days, 12 Months and 2 Years

Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).

Posted

Number

percentage of participants

Discharge, 30 Days, 12 Months and 2 Years

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants

Other Pre-specified

Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram

Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Medtronic Self-Expanding TAV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
OG001	Edwards Balloon-Expandable THV	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Attempted Medtronic Self-Expanding TAV (As Treated Set)	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available) **Note: As Treated set (all subjects with attempted TAVR procedure according to first device used)	43	355	210	355	355
EG001	Attempted Edwards Balloon-Expandable THV (As Treated Set)	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV. Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System **Note: As Treated set (all subjects with attempted TAVR procedure according to first device used)	40	361	207	361	361
EG002	Attempted Both Devices	This arm contains subjects that had a procedural cross-over (i.e., subjects who were first attempted with one device (per randomization assignment) and implanted with the other device at the time of the index TAVR procedure). These subjects are analyzed with the other treatment device in the implanted set.	2	4	4	4	4

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00013 events12 affected355 at risk EG00119 events17 affected361 at risk EG0021 events1 affected4 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Acquired left ventricle outflow tract obstruction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected355 at risk EG0018 events8 affected361 at risk EG0020 events0 affected4 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Angina unstable	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Arrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00028 events27 affected355 at risk EG00141 events29 affected361 at risk EG0021 events1 affected4 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Atrioventricular block	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00034 events32 affected355 at risk EG00117 events17 affected361 at risk EG0021 events1 affected4 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG0011 events1 affected361 at risk EG0021 events1 affected4 at risk
Bifascicular block	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Bundle branch block left	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00017 events17 affected355 at risk EG00115 events15 affected361 at risk EG0021 events1 affected4 at risk
Bundle branch block right	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00012 events9 affected355 at risk EG00117 events15 affected361 at risk EG0021 events1 affected4 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00016 events12 affected355 at risk EG00112 events10 affected361 at risk EG0021 events1 affected4 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Conduction disorder	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0016 events5 affected361 at risk EG0020 events0 affected4 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG0010 events0 affected361 at risk EG0021 events1 affected4 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Mitral valve disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Pericarditis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Sinus arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Trifascicular block	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Ventricular dyssynchrony	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Amaurosis fugax	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Angle closure glaucoma	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cataract	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events1 affected361 at risk EG0020 events0 affected4 at risk
Corneal disorder	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Macular degeneration	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Macular oedema	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Retinal artery occlusion	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Visual impairment	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0014 events3 affected361 at risk EG0020 events0 affected4 at risk
Ascites	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Enteritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Femoral hernia incarcerated	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Adverse drug reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0016 events6 affected361 at risk EG0020 events0 affected4 at risk
Device embolisation	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0021 events1 affected4 at risk
Gait disturbance	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
General physical health deterioration	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hyperplasia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Hypothermia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Impaired healing	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Injection site extravasation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Prosthetic cardiac valve stenosis	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Prosthetic cardiac valve thrombosis	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0017 events7 affected361 at risk EG0020 events0 affected4 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Sudden cardiac death	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Unevaluable event	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Amyloidosis	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Sarcoidosis	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Arthritis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Bacterial sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Breast abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected355 at risk EG00114 events13 affected361 at risk EG0020 events0 affected4 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Clostridial infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Device related infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Endocarditis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0016 events5 affected361 at risk EG0020 events0 affected4 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Enterococcal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Erysipelas	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Helicobacter infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Infective aneurysm	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Intervertebral discitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Lung abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00020 events18 affected355 at risk EG00118 events16 affected361 at risk EG0020 events0 affected4 at risk
Postoperative wound infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Prosthetic valve endocarditis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pyuria	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Septic embolus	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Streptococcal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Tooth abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected355 at risk EG00113 events13 affected361 at risk EG0020 events0 affected4 at risk
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Aortic pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0016 events5 affected361 at risk EG0020 events0 affected4 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Post procedural stroke	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Shoulder fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site dissection	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site occlusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vascular access site rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Electrocardiogram P wave abnormal	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Electrocardiogram QRS complex prolonged	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Electrocardiogram ST segment elevation	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Electrocardiogram change	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Haemoglobin decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Heart rate increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Myocardial necrosis marker increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Transvalvular pressure gradient increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Troponin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Vertebral column mass	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events3 affected361 at risk EG0020 events0 affected4 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0016 events6 affected361 at risk EG0020 events0 affected4 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00015 events14 affected355 at risk EG00110 events10 affected361 at risk EG0022 events2 affected4 at risk
Cervicogenic headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Cognitive disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Dementia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Embolic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0016 events6 affected361 at risk EG0020 events0 affected4 at risk
Epilepsy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Hemiparesis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Parkinson's disease	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Polyneuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Presyncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Sciatica	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Spinal epidural haematoma	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG00110 events10 affected361 at risk EG0020 events0 affected4 at risk
Thalamic infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0018 events6 affected361 at risk EG0020 events0 affected4 at risk
Vascular dementia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Device dislocation	Product Issues	MedDRA 26.0	Systematic Assessment	EG0006 events3 affected355 at risk EG0010 events0 affected361 at risk EG0021 events1 affected4 at risk
Device failure	Product Issues	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Lead dislodgement	Product Issues	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Prosthetic cardiac valve failure	Product Issues	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Prosthetic cardiac valve malfunction	Product Issues	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0018 events8 affected361 at risk EG0020 events0 affected4 at risk
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Disorientation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Major depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Mental disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0021 events1 affected4 at risk
Mental status changes	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0017 events4 affected361 at risk EG0020 events0 affected4 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00012 events11 affected355 at risk EG00116 events13 affected361 at risk EG0020 events0 affected4 at risk
Bladder mass	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Renal infarct	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Urge incontinence	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Breast haematoma	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0021 events1 affected4 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected355 at risk EG0015 events5 affected361 at risk EG0020 events0 affected4 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected355 at risk EG0014 events3 affected361 at risk EG0021 events1 affected4 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Mediastinal haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Pleurocutaneous fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected361 at risk EG0020 events0 affected4 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Peripheral artery bypass	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Aortic aneurysm	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Aortic dissection	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected355 at risk EG0010 events0 affected361 at risk EG0021 events1 affected4 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Femoral artery dissection	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Hypertensive crisis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Hypertensive emergency	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Hypertensive urgency	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0014 events3 affected361 at risk EG0020 events0 affected4 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected355 at risk EG0014 events4 affected361 at risk EG0020 events0 affected4 at risk
Iliac artery dissection	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected361 at risk EG0020 events0 affected4 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Phlebitis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Subgaleal haematoma	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected361 at risk EG0020 events0 affected4 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected361 at risk EG0020 events0 affected4 at risk

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction