RESPOND Post Market Study | NCT02031302

Label	Type	Description	Intervention Names
Lotus Valve		All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.	Device: Lotus Valve System
Lotus with Depth Guard		All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.	Device: Lotus Valve System

Name	Type	Description	Arm Group Labels	Other Names
Lotus Valve System	Device	The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Measure	Description	Time Frame
All-cause Mortality	The primary endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). All-cause mortality at 30 days after the implant procedure will be compared to a pre-specified performance goal.	30 Days
All-cause Mortality	The primary endpoint is all-cause mortality at 1 year after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 4 additional patients died but were not treated with the study valve system (ITT population). The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.	1 Year

Measure	Description	Time Frame
Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke	All subjects who are candidates for transcatheter aortic valve implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve will be evaluated for enrollment in this study (as treated population) The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

Name	Affiliation	Role
Nicolas Van Mieghem, MD	Erasmus Medical Center	Principal Investigator
Volkmar Falk, MD, PhD	German Heart Center Berlin	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Angiografia de Occidente S.A.		Cali			Colombia
Fundacion Cardiovascular de Colombia

PubMed Identifier	Type	Citation	Retractions
30621976	Derived	Van Mieghem NM, Wohrle J, Hildick-Smith D, Bleiziffer S, Blackman DJ, Abdel-Wahab M, Gerckens U, Linke A, Ince H, Wenaweser P, Allocco DJ, Meredith IT, Falk V. Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort. JACC Cardiovasc Interv. 2019 Jan 14;12(1):38-49. doi: 10.1016/j.jcin.2018.10.052.
28651336

ID	Title	Description
FG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement. These are the 1 year outcome.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 8, 2016

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

All-cause Mortality

The primary endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). All-cause mortality at 30 days after the implant procedure will be compared to a pre-specified performance goal.

The primary endpoint analysis is based on the ITT population (1014) through 30 days; 9 subjects out of 1014 subjects are excluded from the analysis because they don't have sufficient follow up, their last follow up days are less than 23 days.

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
OG001	Lotus With Depth Guard	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Units	Counts
Participants	OG0001005 OG00150

Title

Denominators

Categories

Title	Measurements
	OG00026 OG0010

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	Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.	Chi-squared		<.0001	The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.													Other	One-sided Clopper-Pearson 98.699% upper bound

Primary

All-cause Mortality

The primary endpoint is all-cause mortality at 1 year after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted).

A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 4 additional patients died but were not treated with the study valve system (ITT population).

The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

The primary endpoint analysis is based on the ITT population (1014) through 1 year; 12 subjects out of 1014 subjects are excluded from the analysis because they don't have sufficient follow up, their last follow up days are less than 320 days.

Posted

Count of Participants

Participants

1 Year

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Units	Counts

Secondary

Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke

All subjects who are candidates for transcatheter aortic valve implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve will be evaluated for enrollment in this study (as treated population) The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

The Safety composite of all-cause mortality and disabling stroke analysis is based on the as treated population for the Lotus valve arm (996) through 1 year; 8 subjects out of 996 subjects are excluded from the analysis because they don't have sufficient follow up; their last follow up days are less than 320 days.

Posted

Count of Participants

Participants

30 Days and 1 year

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
OG001	Lotus With Depth Guard	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Secondary

In-hospital Mortality

In-hospital mortality till discharge

The In-hospital till discharge analysis is based on the as treated population for the Lotus valve arm (996). In the Lotus with Depth Guard arm are all patients treated with the device.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 2 days

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
OG001	Lotus With Depth Guard	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Secondary

Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint

The VARC efficacy composite at 1 year, including all-cause mortality; all stroke (disabling and non-disabling); re-hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); and prosthetic valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA) ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve aortic regurgitation)

The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year. 443 patients had no Echo analysis and therefore no data available.

Posted

Count of Participants

Participants

1 Year

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Units	Counts
Participants

Secondary

Patients With Valve Safety Composite Outcomes at 1 Year

Time related valve safety composite outcomes at 1 year, including structural valve deterioration (valve-related dysfunction requiring repeat procedure [TAVI or SAVR]); prosthetic valve endocarditis; prosthetic valve thrombosis; thromboembolic events (e.g. stroke) and VARC bleeding, unless clearly unrelated to valve therapy based on investigator assessment (e.g. trauma).

The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

The analysis of patients with valve safety composite outcomes at 1 year is based on the as treated population for the Lotus valve arm (996) through 1 year; 8 subjects out of 996 subjects are excluded from the analysis because they don't have sufficient follow up; their last follow up days are less than 320 days.

Posted

Count of Participants

Participants

1 Year

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Units

Secondary

Patients With VARC Safety Composite Outcomes at 30 Days

Patients with VARC safety composite outcomes at 30 days. VARC safety composite endpoints are defined as:

Life-threatening bleeding
Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
New conduction disturbances (LBBB, AVB, RBBB) and need for permanent pacemaker implantation

The analysis of patients with valve safety composite outcomes at 30 days based on the as treated population for the Lotus valve arm (996) through 30 days. In the Lotus with Depth Guard arm are all patients treated with the device.

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
OG001	Lotus With Depth Guard	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Secondary

Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation

Grade of paravalvular aortic valve regurgitation pre-discharge as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. The moderate and severe paravalvular aortic regurgitation rate will be compared to a pre-specified performance goal.

We don't have a powered analysis for the PVL for RESPOND study.

62 patients had no data available for the analysis in the Lotus Valve arm. 13 patients had no data for the analysis in the Lotus with Depth Guard arm.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 2 days

ID	Title	Description
OG000	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
OG001	Lotus With Depth Guard	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Total	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG000354 events327 affected1,014 at risk EG001451 events382 affected1,014 at risk EG0029 events9 affected50 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG000149 events149 affected1,014 at risk EG001155 events155 affected1,014 at risk EG0026 events6 affected50 at risk
Conduction disorder	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00057 events57 affected1,014 at risk EG00158 events58 affected1,014 at risk EG0021 events1 affected50 at risk
Cardiac failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected1,014 at risk EG00147 events46 affected1,014 at risk EG0020 events0 affected50 at risk
Bundle branch block left	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00019 events19 affected1,014 at risk EG00124 events24 affected1,014 at risk EG0020 events0 affected50 at risk
Atrioventricular block	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00020 events20 affected1,014 at risk EG00120 events20 affected1,014 at risk EG0021 events1 affected50 at risk
Bradycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events12 affected1,014 at risk EG00114 events14 affected1,014 at risk EG0020 events0 affected50 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events12 affected1,014 at risk EG00113 events13 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG00112 events11 affected1,014 at risk EG0020 events0 affected50 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00011 events11 affected1,014 at risk EG00111 events11 affected1,014 at risk EG0020 events0 affected50 at risk
Pericardial effusion	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events10 affected1,014 at risk EG00111 events11 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected1,014 at risk EG0019 events9 affected1,014 at risk EG0020 events0 affected50 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0017 events7 affected1,014 at risk EG0020 events0 affected50 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected1,014 at risk EG0017 events7 affected1,014 at risk EG0020 events0 affected50 at risk
Myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0017 events7 affected1,014 at risk EG0020 events0 affected50 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected1,014 at risk EG0015 events5 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected1,014 at risk EG0015 events5 affected1,014 at risk EG0020 events0 affected50 at risk
Trifascicular block	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected1,014 at risk EG0014 events4 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Aortic valve disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac asthma	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Arrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Atrial flutter	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Bundle branch block	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Bundle branch block right	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Electromechanical dissociation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Left ventricular failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Nodal rhythm	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0021 events1 affected50 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Sinoatrial block	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Ventricular asystole	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00052 events50 affected1,014 at risk EG00170 events66 affected1,014 at risk EG0022 events2 affected50 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00026 events25 affected1,014 at risk EG00130 events29 affected1,014 at risk EG0022 events2 affected50 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected1,014 at risk EG00111 events11 affected1,014 at risk EG0020 events0 affected50 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected1,014 at risk EG0018 events8 affected1,014 at risk EG0020 events0 affected50 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0015 events5 affected1,014 at risk EG0020 events0 affected50 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Renal injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00035 events34 affected1,014 at risk EG00163 events56 affected1,014 at risk EG0023 events3 affected50 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00017 events17 affected1,014 at risk EG00132 events30 affected1,014 at risk EG0022 events2 affected50 at risk
Cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected1,014 at risk EG0016 events6 affected1,014 at risk EG0021 events1 affected50 at risk
Hemiparesis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected1,014 at risk EG0015 events5 affected1,014 at risk EG0020 events0 affected50 at risk
Syncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Cerebral haematoma	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Embolic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Lacunar infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Status epilepticus	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	General disorders	MedDRA (12.1)	Systematic Assessment	EG00027 events27 affected1,014 at risk EG00154 events54 affected1,014 at risk EG0021 events1 affected50 at risk
Death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG00119 events19 affected1,014 at risk EG0020 events0 affected50 at risk
Catheter site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG00014 events14 affected1,014 at risk EG00114 events14 affected1,014 at risk EG0021 events1 affected50 at risk
Multi-organ failure	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0018 events8 affected1,014 at risk EG0020 events0 affected50 at risk
Catheter site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected1,014 at risk EG0017 events7 affected1,014 at risk EG0020 events0 affected50 at risk
Impaired healing	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Implant site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Obstruction	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Puncture site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Ulcer haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected1,014 at risk EG00133 events32 affected1,014 at risk EG0020 events0 affected50 at risk
Sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG00110 events10 affected1,014 at risk EG0020 events0 affected50 at risk
Endocarditis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0018 events8 affected1,014 at risk EG0020 events0 affected50 at risk
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0016 events6 affected1,014 at risk EG0020 events0 affected50 at risk
Endocarditis bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Septic shock	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Bronchopneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Cardiac valve abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Urosepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Wound infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00034 events32 affected1,014 at risk EG00133 events30 affected1,014 at risk EG0020 events0 affected50 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected1,014 at risk EG0017 events7 affected1,014 at risk EG0020 events0 affected50 at risk
Femoral artery occlusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected1,014 at risk EG0014 events4 affected1,014 at risk EG0020 events0 affected50 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected1,014 at risk EG0014 events4 affected1,014 at risk EG0020 events0 affected50 at risk
Femoral artery dissection	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0010 events0 affected1,014 at risk EG0020 events0 affected50 at risk
Haematoma	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Haemorrhage	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Iliac artery occlusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Aneurysm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Aortic dissection	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Artery dissection	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0010 events0 affected1,014 at risk EG0020 events0 affected50 at risk
Extremity necrosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Iliac artery embolism	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Iliac artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG00022 events22 affected1,014 at risk EG00127 events27 affected1,014 at risk EG0021 events1 affected50 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG00016 events16 affected1,014 at risk EG00118 events18 affected1,014 at risk EG0021 events1 affected50 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0015 events5 affected1,014 at risk EG0020 events0 affected50 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected1,014 at risk EG00116 events15 affected1,014 at risk EG0020 events0 affected50 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0014 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG00113 events13 affected1,014 at risk EG0020 events0 affected50 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0014 events4 affected1,014 at risk EG0020 events0 affected50 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected1,014 at risk EG00112 events12 affected1,014 at risk EG0021 events1 affected50 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected1,014 at risk EG0014 events4 affected1,014 at risk EG0021 events1 affected50 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0014 events4 affected1,014 at risk EG0020 events0 affected50 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0018 events8 affected1,014 at risk EG0020 events0 affected50 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
T-cell prolymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Investigations	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected1,014 at risk EG0017 events7 affected1,014 at risk EG0020 events0 affected50 at risk
Haemoglobin decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Echocardiogram abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Electrocardiogram abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected1,014 at risk EG0013 events3 affected1,014 at risk EG0020 events0 affected50 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Marasmus	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0012 events2 affected1,014 at risk EG0020 events0 affected50 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Retinal artery occlusion	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Total	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 at risk
Completed suicide	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected1,014 at risk EG0011 events1 affected1,014 at risk EG0020 events0 affected50 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	Lotus Valve	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
BG001	Lotus With Depth Guard	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lotus Valve (30 Day Follow Up)	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	22	987	426	1,014	96	1,014
EG001	Lotus Valve (1 Year Follow Up)	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	116	988	525	1,014	99	1,014
EG002	Lotus With Depth Guard (30 Day Follow Up)	All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	0	50	14	50	7	50

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bundle branch block left	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment		EG00086 events85 affected1,014 at risk EG00189 events88 affected1,014 at risk EG0024 events4 affected50 at risk
Catheter site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment		EG00011 events11 affected1,014 at risk EG00111 events11 affected1,014 at risk EG0023 events3 affected50 at risk