ACURATE IDE: Safety and Effectiveness Study of ACURATE Va... | NCT03735667

Description Module

Detailed Description

Subjects will be enrolled at up to 85 centers in the United States, Canada, Europe, and Australia. There will be up to 2,820 subjects in ACURATE IDE.

The ACURATE IDE study cohorts include the following.

Main Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]). There will be up to 1,500 subjects in the RCT.
Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Boston Scientific Corporation, Marlborough, MA, USA) will perform at least 2 roll-in cases before commencing treatment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.
4D CT Imaging Substudy: Selected centers with the ability to perform high quality 4D computer tomography (CT) scans will include subjects in a 4D CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and hypoattenuated leaflet thickening (HALT) and the relationship, if any, to clinical events. Subjects will be randomized to test (ACURATE) and control device.
ACURATE Prime™ XL Nested Registry: A non-randomized, nested registry cohort of subjects who will receive the ACURATE Prime™ Transfemoral Aortic Valve System XL (ACURATE Prime XL Nested Registry). Participating centers will be a subset of United States centers that have enrolled subjects in ACURATE IDE. Data from subjects in this nested registry will be summarized separately from the randomized and roll-in cohorts.
ACURATE Extended Durability Study: An additional 1:1 randomized study (ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]) including only subjects considered to be at low surgical risk. Subjects will receive ACURATE neo2 (S, M, or L valve sizes) or ACURATE Prime XL. Data from subjects in the Extended Durability Study will be summarized separately from other cohorts.
ACURATE Continued Access Study (CAS): An additional cohort of subjects receiving ACURATE neo2 (S, M, and L valve sizes) or ACURATE Prime XL. Data from subjects in the ACURATE CAS will be summarized separately from other cohorts and will be used to further assess performance and safety.

Follow-up

Subjects implanted with a test device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for 5 years post-procedure.
Subjects implanted with a control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure. Per protocol, no additional follow-up is required beyond this period, and standard of care practices will apply.
Some subjects may have completed additional annual follow-up visits based on requirements outlined in earlier versions of the protocol.
Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACURATE Valve - Main Randomized	Experimental	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.	Device: ACURATE neo2™ Transfemoral TAVR System
ACURATE Valve - Single-arm Roll-in	Experimental	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.	Device: ACURATE neo2™ Transfemoral TAVR System
Commercial Valve - Main Randomized	Active Comparator	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.	Device: Medtronic CoreValve TAVR System Device: Edwards SAPIEN 3 TAVR System
ACURATE Valve - Single-arm Prime XL	Experimental	Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL. *50 subjects will be enrolled in the Prime™ XL Nested Registry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACURATE neo2™ Transfemoral TAVR System	Device	ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).

Measure	Description	Time Frame
Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.	Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. * Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.	Participants will be followed for the duration of hospital stay through 1 year.

Measure	Description	Time Frame
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics.

Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.

IC2. Subject has a documented aortic annulus size of ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device.
IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.
IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.
IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

Exclusion Criteria:

EC1. Subject has a unicuspid or bicuspid aortic valve.
EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
EC4. Subject is on renal replacement therapy or has eGFR <20.
EC5. Subject has a pre-existing prosthetic aortic or mitral valve.
EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76).
EC8. Subject has a need for emergency surgery for any reason.
EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
EC11. Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate [PET]).
EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
EC15. Subject has hypertrophic cardiomyopathy.
EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed).
EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use.
EC21. Subject has either of the following:
- Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
- Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis.
EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.
EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure.
EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
EC25. Subject has severe incapacitating dementia.

Additional exclusion criteria apply to subjects considered for enrollment in the CT Imaging Substudy as listed below.

AEC1. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V)
AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index procedure.

Note: Subjects treated with short-term anticoagulation post procedure can be included in the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Name	Affiliation	Role
Raj R. Makkar, MD	Cedars-Sinai Heart Institute	Principal Investigator
Michael J. Reardon, MD	Methodist DeBakey Heart & Vascular Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Banner Good Samaritan

PubMed Identifier	Type	Citation	Retractions
40406945	Background	Makkar RR, Chakravarty T, Gupta A, Soliman O, Gnall E, Ramana RK, Ramlawi B, Diamantouros P, Potluri S, Kleiman NS, Samy S, Rassi A, Yadav P, Thourani V, Yakubov S, Frawley C, Patel D, Kapadia S, Chalekian A, Modolo R, Sathananthan J, Kim WK, Reardon MJ. Valve Underexpansion and Clinical Outcomes With ACURATE neo2: Findings From the ACURATE IDE Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):225-238. doi: 10.1016/j.jacc.2025.05.011. Epub 2025 May 21.
40412426

ID	Title	Description
FG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
FG001	Commercial Valve - Main Randomized

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 20, 2023	Feb 24, 2025

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
	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002148 ParticipantsBG003

Sex/Gender, Customized

Count of Participants

Participants

Title	Denominators	Categories
Male	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Race/Ethnicity, Customized

Note - As subjects had the option to select more than one race/ethnicity, the sum of participants in this Baseline Measure does not equal the overall number of Baseline Participants in each Arm/Group.

Count of Participants

Participants

Title	Denominators	Categories
American Indian or Alaska Native	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Canada	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m2

Title	Denominators	Categories
	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Aortic Annulus Area

Computed Tomography Angiography (CTA) Core Laboratory Analysis

Mean

Standard Deviation

mm2

Title	Denominators	Categories
	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Aortic Annulus Perimeter

Computed Tomography Angiography (CTA) Core Laboratory Analysis

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Medical History

Number

Percentage of participants

Title	Denominators	Categories
History of hypertension	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

New York Heart Association (NYHA) Classification

NYHA Classification:

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

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

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

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

Number

Percentage of participants

Title	Denominators	Categories
Class I	ParticipantsBG000752 ParticipantsBG001748

Operative Risk Group

The subject operative risk is assessed by the site Heart Team and then confirmed by the Case Review Committee who ultimately confirms the subject eligibility for the enrollment in the study.

Number

Percentage of participants

Title	Denominators	Categories
High/Extreme	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Society of Thoracic Surgeons (STS) Risk Score

The Society of Thoracic Surgeons Score is a risk model used to predict a subject's risk of mortality and morbidities for the most commonly performed cardiac surgeries. The model is a percentage score from 0 to 100 where a lower score means a lower risk and higher score means a higher risk.

Mean

Standard Deviation

Percent

Title	Denominators	Categories
	ParticipantsBG000752 ParticipantsBG001748 ParticipantsBG002

Aortic Valve Area (AVA)

Transthoracic Echocardiography (TTE) - Core Laboratory Analysis

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Mean

Standard Deviation

cm2

Title	Denominators	Categories
	ParticipantsBG000724 ParticipantsBG001716 ParticipantsBG002

Doppler Velocity Index (DVI)

Transthoracic Echocardiography (TTE) - Core Laboratory Analysis

DVI=LVOT Velocity/AV Velocity

Lower DVI values (< 0.25): Suggest severe aortic stenosis. This indicates that the velocity through the LVOT is much lower relative to the high velocity through the stenotic aortic valve.
Intermediate values (approximately 0.25-0.50): May indicate moderate stenosis.
Higher DVI values (> 0.50): Are generally considered normal or only mildly abnormal, indicating minimal obstruction.

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Mean

Standard Deviation

Index

Title	Denominators	Categories
	ParticipantsBG000731 ParticipantsBG001

Aortic Valve Mean Pressure Gradient

Transthoracic Echocardiography (TTE) - Core Laboratory Analysis

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
	ParticipantsBG000734 ParticipantsBG001726 ParticipantsBG002

Aortic Valve Peak Velocity

Transthoracic Echocardiography (TTE) - Core Laboratory Analysis

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Mean

Standard Deviation

m/s

Title	Denominators	Categories
	ParticipantsBG000734 ParticipantsBG001726 ParticipantsBG002

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

Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.

Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis.

* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.

Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Participants will be followed for the duration of hospital stay through 1 year.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Units	Counts
Participants	OG000752 OG001748

Title

Denominators

Categories

Title	Measurements
	OG00016.16(13.38 to 19.07) OG0019.53(7.47 to 11.89)

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																		Non-Inferiority	A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.	A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).

Other Pre-specified

Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.

Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.

Evaluable for clinical endpoints at 30 days/6 Months/1 Year is defined as subjects who experience an event through 30 days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.

Posted

Number

percentage of participants

Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of All Stroke: Disabling and Non-disabling

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.

Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Bleeding: Life-threatening (or Disabling) and Major

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Major Vascular Complications

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of New Onset of Atrial Fibrillation or Atrial Flutter

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

percentage of participants

Participants will be followed peri- and post-procedure, through 7 days post index procedure.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Coronary Obstruction: Periprocedural

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) - based on VARC endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed through 72 hours post index procedure

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Ventricular Septal Perforation: Periprocedural

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed through 72 hours post index procedure

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Mitral Apparatus Damage: Periprocedural

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed through 72 hours post index procedure

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Cardiac Tamponade: Periprocedural

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed through 72 hours post index procedure

ID	Title	Description
OG000	ACURATE Neo 2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Valve Migration

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Valve Embolization

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Ectopic Valve Deployment

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed peri- and post-procedure through discharge or 7 days post-procedure (whichever comes first).

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Prosthetic Aortic Valve Thrombosis

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Prosthetic Aortic Valve Endocarditis

Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment)

Device Performance outcome, as measured by site reported data based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed for the duration of their procedure, an expected average of 1 Day (peri- and post-procedure)

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)

Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Posted

Number

percentage of participants

Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Rate of Device Success

Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area [iEOA] >0.85 cm2/m2 for BMI <30 kg/cm2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient <20 mmHg or a peak velocity < 3m, and no moderate or severe prosthetic valve aortic regurgitation) based on VARC-2 endpoints and definitions.

Posted

Number

Percentage of participants

Participants will be followed for the duration of their procedure, an expected average of 1 Day (post-procedure)

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Effective Orifice Area (EOA)

Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Posted

Mean

Standard Deviation

cm2

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Mean Aortic Gradient

Mean Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.

Posted

Mean

Standard Deviation

mmHg

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

New York Heart Association (NYHA) Functional Status Classification

Health status evaluated by New York Heart Association (NYHA) Classification.

NYHA Classification:

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

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

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

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

NYHA class denominator is the number of subjects with non-missing NYHA class at the studied timepoint.

Posted

Number

Percentage of participants

Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized

Other Pre-specified

Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline

Health Status additional outcome KCCQ Analysis - Overall Summary Score change from Baseline.

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

Overall Summary Score - mean of score 1, 5, 7, and 8

Note: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.

Posted

Mean

Standard Deviation

Score on a scale

Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Other Pre-specified

Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline

Health Status outcome - SF-12 - Baseline scores and changes from Baseline at 30 Days and 1 Year.

12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Note: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.

Posted

Mean

Standard Deviation

Score on a scale

Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.

ID	Title	Description
OG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
OG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00010 events10 affected752 at risk EG0014 events4 affected748 at risk EG0025 events4 affected148 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Cold type haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0016 events6 affected748 at risk EG0020 events0 affected148 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0014 events4 affected748 at risk EG0022 events2 affected148 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00013 events12 affected752 at risk EG0014 events4 affected748 at risk EG0022 events1 affected148 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00013 events13 affected752 at risk EG0016 events5 affected748 at risk EG0020 events0 affected148 at risk
Angina pectoris	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0015 events5 affected748 at risk EG0020 events0 affected148 at risk
Angina unstable	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Aortic valve thickening	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Arrhythmia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00037 events32 affected752 at risk EG00140 events38 affected748 at risk EG00211 events7 affected148 at risk
Atrial flutter	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Atrioventricular block	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00053 events52 affected752 at risk EG00170 events68 affected748 at risk EG0027 events7 affected148 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0005 events5 affected752 at risk EG0017 events7 affected748 at risk EG0020 events0 affected148 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0007 events7 affected752 at risk EG0016 events6 affected748 at risk EG0021 events1 affected148 at risk
Bradycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0019 events9 affected748 at risk EG0020 events0 affected148 at risk
Bundle branch block	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Bundle branch block left	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00032 events32 affected752 at risk EG00130 events30 affected748 at risk EG0022 events2 affected148 at risk
Bundle branch block right	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0015 events5 affected748 at risk EG0020 events0 affected148 at risk
Cardiac arrest	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00011 events11 affected752 at risk EG0013 events3 affected748 at risk EG0022 events2 affected148 at risk
Cardiac failure	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0008 events7 affected752 at risk EG0019 events8 affected748 at risk EG0022 events1 affected148 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00010 events9 affected752 at risk EG0018 events8 affected748 at risk EG0024 events3 affected148 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG00028 events22 affected752 at risk EG00122 events19 affected748 at risk EG00211 events8 affected148 at risk
Cardiac perforation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Cardiomegaly	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Conduction disorder	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Coronary artery disease	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0022 events2 affected148 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hyperdynamic left ventricle	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Left ventricular failure	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0005 events5 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Myocardial infarction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0007 events7 affected752 at risk EG0013 events2 affected748 at risk EG0020 events0 affected148 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events3 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Myocardial rupture	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Myocarditis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Nodal rhythm	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Palpitations	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Paravalvular aortic regurgitation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Pericardial effusion	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Pericarditis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Prosthetic cardiac valve thrombosis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0016 events6 affected748 at risk EG0020 events0 affected148 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Sinus arrest	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0022 events2 affected148 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0017 events7 affected748 at risk EG0022 events2 affected148 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events2 affected752 at risk EG0015 events5 affected748 at risk EG0020 events0 affected148 at risk
Tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0022 events2 affected148 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0013 events1 affected748 at risk EG0020 events0 affected148 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Skin malformation	Congenital, familial and genetic disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cushing's syndrome	Endocrine disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cataract	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0022 events1 affected148 at risk
Cataract nuclear	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Glaucoma	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Iritis	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Photophobia	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Retinal detachment	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Retinal infarction	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Vision blurred	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Ascites	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Colitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Gastric ileus	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Gastritis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0007 events7 affected752 at risk EG00110 events8 affected748 at risk EG0021 events1 affected148 at risk
Gastrointestinal vascular malformation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Ileus	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Internal hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Intussusception	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Melaena	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events1 affected752 at risk EG0013 events2 affected748 at risk EG0020 events0 affected148 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events1 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0013 events3 affected748 at risk EG0022 events2 affected148 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Asthenia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Catheter site haematoma	General disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Catheter site haemorrhage	General disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Catheter site pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Catheter site thrombosis	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Chest pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Complication associated with device	General disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Cyst	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Death	General disorders	MedDRA (21.0)	Systematic Assessment	EG00011 events11 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Device embolisation	General disorders	MedDRA (21.0)	Systematic Assessment	EG0007 events7 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Gait disturbance	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Hypothermia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Non-cardiac chest pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0014 events4 affected748 at risk EG0021 events1 affected148 at risk
Pyrexia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0005 events5 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Contrast media allergy	Immune system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hypersensitivity	Immune system disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Abdominal wall infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Acute sinusitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Appendicitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Arthritis bacterial	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0003 events2 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Bacteraemia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Bacterial infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Bronchitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Catheter site cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Catheter site infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0007 events7 affected752 at risk EG0012 events2 affected748 at risk EG0025 events5 affected148 at risk
Chronic sinusitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Clostridial sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Corona virus infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00012 events12 affected752 at risk EG0017 events7 affected748 at risk EG0022 events2 affected148 at risk
Cystitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Device related infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Diverticulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Endocarditis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events2 affected748 at risk EG0020 events0 affected148 at risk
Endocarditis bacterial	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Enterococcal infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0022 events2 affected148 at risk
Epididymitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Escherichia sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Gangrene	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Gastroenteritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Haematoma infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Herpes zoster	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Implant site infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Localised infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Muscle abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Necrotising soft tissue infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Osteomyelitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Osteomyelitis acute	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pelvic abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pneumonia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00016 events15 affected752 at risk EG00119 events19 affected748 at risk EG0025 events5 affected148 at risk
Postoperative wound infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pseudomonas infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Pyelonephritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0009 events9 affected752 at risk EG00116 events14 affected748 at risk EG0025 events5 affected148 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Septic encephalopathy	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Septic shock	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Soft tissue infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Staphylococcal infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events1 affected748 at risk EG0020 events0 affected148 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0022 events2 affected148 at risk
Streptococcal infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Tooth infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00019 events17 affected752 at risk EG00110 events10 affected748 at risk EG0022 events2 affected148 at risk
Urosepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0015 events5 affected748 at risk EG0020 events0 affected148 at risk
Wound infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Device deployment issue	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG00011 events11 affected752 at risk EG0016 events6 affected748 at risk EG0023 events3 affected148 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Structural valve deterioration	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0016 events6 affected748 at risk EG0020 events0 affected148 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0004 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Trunk injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Urethral injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Vascular access site complication	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Vascular injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0005 events4 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0014 events4 affected748 at risk EG0023 events3 affected148 at risk
Vascular pseudoaneurysm thrombosis	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Vasoplegia syndrome	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Bleeding time prolonged	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
CSF test abnormal	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Coronavirus test positive	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Echocardiogram abnormal	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Electrocardiogram QRS complex prolonged	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
International normalised ratio increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lactescent serum	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pedal pulse decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Troponin increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0022 events2 affected148 at risk
White blood cell count increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events1 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Gout	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0022 events2 affected148 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0013 events2 affected748 at risk EG0020 events0 affected148 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0007 events6 affected752 at risk EG0016 events6 affected748 at risk EG0022 events2 affected148 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Acute megakaryocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0005 events4 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Benign uterine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Breast cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Metastatic carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Aphasia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Ataxia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Brain injury	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cerebellar ataxia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cerebellar stroke	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0005 events3 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Cerebral infarction	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0013 events3 affected748 at risk EG0022 events2 affected148 at risk
Cerebral microhaemorrhage	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00030 events28 affected752 at risk EG00112 events12 affected748 at risk EG0026 events6 affected148 at risk
Chorea	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Dementia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Dizziness	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Dysarthria	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Encephalopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0015 events5 affected748 at risk EG0020 events0 affected148 at risk
Facial paralysis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Hemiparesis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hyponatraemic encephalopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0006 events6 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Lethargy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Migraine with aura	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Multiple system atrophy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Myelopathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Nervous system disorder	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Neurodegenerative disorder	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Paralysis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Parkinson's disease	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Parkinsonism	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Periventricular leukomalacia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Presyncope	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0008 events8 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Sciatica	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Seizure	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Status epilepticus	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Syncope	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0009 events8 affected752 at risk EG0015 events5 affected748 at risk EG0026 events6 affected148 at risk
Transient global amnesia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00013 events12 affected752 at risk EG0017 events7 affected748 at risk EG0020 events0 affected148 at risk
Tremor	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Visual field defect	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Device dislocation	Product Issues	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Device failure	Product Issues	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Device leakage	Product Issues	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Device occlusion	Product Issues	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Confusional state	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Delirium	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Delirium tremens	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hallucination	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Mental status changes	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0016 events6 affected748 at risk EG0021 events1 affected148 at risk
Substance abuse	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG00026 events22 affected752 at risk EG00118 events17 affected748 at risk EG0028 events7 affected148 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Haematuria	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0006 events4 affected752 at risk EG0017 events6 affected748 at risk EG0020 events0 affected148 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Renal failure	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Urinary retention	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Ovarian mass	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0009 events9 affected752 at risk EG0012 events2 affected748 at risk EG0022 events1 affected148 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0008 events6 affected752 at risk EG0013 events3 affected748 at risk EG0023 events2 affected148 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events4 affected752 at risk EG0016 events6 affected748 at risk EG0020 events0 affected148 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0014 events4 affected748 at risk EG0021 events1 affected148 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0015 events5 affected748 at risk EG0020 events0 affected148 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0021 events1 affected148 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0022 events2 affected148 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00012 events11 affected752 at risk EG00118 events17 affected748 at risk EG0022 events2 affected148 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Air embolism	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected748 at risk EG0021 events1 affected148 at risk
Angiopathy	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Aortic aneurysm	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Aortic dissection	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Arterial rupture	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Arteriosclerosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0004 events3 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Distributive shock	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Dry gangrene	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Extremity necrosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Femoral artery dissection	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0020 events0 affected148 at risk
Haematoma	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Haemodynamic instability	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Haemorrhage	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Hypertension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0003 events3 affected752 at risk EG0016 events6 affected748 at risk EG0022 events2 affected148 at risk
Hypertensive crisis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0014 events4 affected748 at risk EG0020 events0 affected148 at risk
Hypertensive emergency	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Hypotension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG00015 events15 affected752 at risk EG0016 events6 affected748 at risk EG0021 events1 affected148 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Iliac artery perforation	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Intermittent claudication	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Lymphorrhoea	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Malignant hypertension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Necrosis ischaemic	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Paradoxical embolism	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Penetrating aortic ulcer	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Peripheral artery dissection	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0002 events2 affected752 at risk EG0013 events3 affected748 at risk EG0021 events1 affected148 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0006 events6 affected752 at risk EG0012 events2 affected748 at risk EG0022 events2 affected148 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0021 events1 affected148 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected748 at risk EG0020 events0 affected148 at risk
Shock	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Subclavian artery aneurysm	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Subclavian artery thrombosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Thrombosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Vascular calcification	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected748 at risk EG0020 events0 affected148 at risk
Vascular occlusion	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected748 at risk EG0020 events0 affected148 at risk

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

ID	Title	Description
BG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
BG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR,Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
BG002	ACURATE neo2 Valve - Single-arm Roll-in	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ACURATE neo2 Valve - Main Randomized	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.	36	752	389	752	155	752
EG001	Commercial Valve - Main Randomized	Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System. Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.	28	748	381	748	145	748
EG002	ACURATE neo2 Valve - Single-arm Roll-in	Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.	7	148	81	148	26	148