Safety and Efficacy Study of Lotus Valve for Transcathete... | NCT02202434

Label	Type	Description	Intervention Names
Lotus Valve System - Randomized	Experimental	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System	Device: Lotus Valve System
CoreValve TAVR System - Randomized	Active Comparator	Transcatheter aortic valve replacement (TAVR) with CoreValve/Evolut R Transcatheter Aortic Valve Replacement System	Device: CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
Lotus Valve Sytem - Single-arm 21mm Cohort	Experimental	Transcatheter aortic valve replacement (TAVR) with 21mm Lotus Valve System	Device: Lotus Valve System
Lotus Valve System - Single-arm Continued Access Cohort	Experimental	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System	Device: Lotus Valve System
Lotus Valve System - Single-arm Roll-in Cohort	Experimental	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System	Device: Lotus Valve System
LOTUS Edge Valve System - Single-arm Edge Nested Registry

Name	Type	Description	Arm Group Labels	Other Names
Lotus Valve System	Device	Procedure: Transcatheter aortic valve replacement (TAVR)	Lotus Valve System - Randomized Lotus Valve System - Single-arm Continued Access Cohort

Measure	Description	Time Frame
Percentage of Participants With Events Included in the Primary Safety Endpoint	Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications	30 days following procedure
Percentage of Participants With Events Included in the Primary Effectiveness Endpoint	Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).	1 year following procedure

Measure	Description	Time Frame
Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation	Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).

Measure	Description	Time Frame
Percentage of Participants With Successful Deployment of the Study Valve	Successful deployment of the study valve	at discharge or 7 days post-procedure (whichever comes first)
Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has documented calcific, severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure gradient >40 mm Hg or jet velocity >4.0 m/s, as measured by echocardiography and/or invasive hemodynamics
Subject has a documented aortic annulus size of ≥18 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 randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is ≥20 mm and ≤27 mm.
Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II
There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.
- Society of Thoracic Surgeons (STS) score ≥8% -OR-
- If STS <8, subject has at least one of the following conditions: Hostile chest, porcelain aorta, severe pulmonary hypertension (>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second [FEV1] <50% of predicted, diffusing capacity of the lungs for carbon monoxide [DLCO] <60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5-meter walk >6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index <21, wheelchair bound, unable to live independently, age ≥90 years, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)
Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
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.

Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).

Exclusion Criteria:

Subject has a congenital unicuspid or bicuspid aortic valve.
Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
Subject has end-stage renal disease or has glomerular filtration rate (GFR) <20 (based on Cockcroft-Gault formula).
Subject has a pre-existing prosthetic aortic or mitral valve.
Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
Subject has a need for emergency surgery for any reason.
Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
Subject has echocardiographic evidence of new intra-cardiac mass, vegetation or intraventricular or paravalvular thrombus requiring intervention.
Subject has (hemoglobin) Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
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.
Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
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.
Subject has hypertrophic obstructive cardiomyopathy.
Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker implantation, which are allowed).
Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
Subject has severe left ventricular dysfunction with ejection fraction <20%.
Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
Subject has 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 symptomatic carotid or vertebral disease).
Subject has thick (>5 mm) protruding or ulcerated atheroma in the aortic arch
Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use.
Subject has current problems with substance abuse (e.g., alcohol, etc.).
Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
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.
Subject has severe incapacitating dementia.

Name	Affiliation	Role
David Rizik, MD	Scottsdale Healthcare - Shea	Principal Investigator
Michael J Reardon, MD	The Methodist Hospital Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Banner Good Samaritan		Phoenix	Arizona	85018	United States
Scottsdale Healthcare - Shea

PubMed Identifier	Type	Citation	Retractions
36301543	Derived	Rizik DG, Rajagopal V, Makkar RR, Bajwa T, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Iyer VS, Buchbinder M, Gotberg M, Bjursten H, Allocco DJ, Reardon MJ. Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238792. doi: 10.1001/jamanetworkopen.2022.38792.
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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
FG001	CoreValve TAVR System - Randomized

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 6, 2017

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

Lotus Valve System - Randomized

Title	Measurements
	BG00082.8± 7.1 BG0010± 0 BG0020± 0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000304 BG001159 BG002

Race/Ethnicity, Customized

Subjects were allowed to select more than one option.

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0001 BG0011 BG002

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

Lotus Valve System - Randomized

Title	Measurements
	BG0006.7± 4.0 BG001

European System for Cardiac Operative Risk Evaluation (EuroSCORE)

The European System for Cardiac Operative Risk Evaluation is a risk model where if a risk factor is present in a subject, a weight or number is assigned. The weights are added to give an approximate percent predicted mortality. A higher score means a higher risk and a lower score means a lower risk.

Mean

Standard Deviation

Percent

Title

Denominators

Categories

Lotus Valve System - Randomized

Title	Measurements
	BG0006.4± 5.5 BG001

New York Heart Association (NYHA) Classification

New York Heart Association Classification is a system for defining cardiac disease and related functional limitations into four broad categorizations. The categories range from NYHA I (No limitations) to NYHA IV (inability to carry out any physical activity without discomfort).

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
NYHA I	BG0000 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Events Included in the Primary Safety Endpoint

Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications

Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.

Posted

Number

Percent of participants

30 days following procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Units	Counts
Participants	OG000577 OG001297

Title

Denominators

Categories

Title	Measurements
	OG00020.3 OG00117.2

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		Farrington-Manning		0.0027		Difference in Percentages	3.1			1-Sided	97.5		8.32					Non-Inferiority	10.5% non-inferiority margin

Primary

Percentage of Participants With Events Included in the Primary Effectiveness Endpoint

Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).

Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.

Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms.

Posted

Number

Percent of Participants

1 year following procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Units	Counts

Secondary

Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation

Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).

ITT - 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.

The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.

Posted

Number

Percent of Participants

1 year following procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Successful Deployment of the Study Valve

Successful deployment of the study valve

Intent to Treat

Posted

Number

Percentage of participants

at discharge or 7 days post-procedure (whichever comes first)

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Other Pre-specified

Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted

Successful retrieval of the study valve if retrieval is attempted

Number of Intent to Treat participants who had Retrieval attempted

Posted

Number

Percentage of Participants

at discharge or 7 days post-procedure (whichever comes first)

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Other Pre-specified

Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted

Successful repositioning of the study valve if repositioning is attempted

Number of Intent to Treat participants who had Repositioning attempted

Posted

Number

Percentage of Participants

at discharge or 7 days post-procedure (whichever comes first)

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined

Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.

The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).

Intent to Treat

Posted

Number

Percentage of Participants

at discharge or 7 days post-procedure (whichever comes first)

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort

Other Pre-specified

Percentage of Participants With Clinical Procedural Success

Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding

Intent to Treat

Posted

Number

Percentage of Participants

30 days post procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Other Pre-specified

Percentage of Participants With Procedural Success

Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for body surface area (BSA) <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events

Intent to Treat

Posted

Number

Percentage of participants

30 days post procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1

Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity

Intent to Treat

Posted

Mean

Standard Deviation

cm^2

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2

Assessed by an independent core laboratory - mean and peak aortic gradients

Intent to Treat

Posted

Mean

Standard Deviation

mmHg

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3

Assessed by an independent core laboratory - peak aortic velocity

Intent to Treat

Posted

Mean

Standard Deviation

m/s

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4

The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002

Other Pre-specified

Health Status as Evaluated by Quality of Life Questionnaires

SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year

SF-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.
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.

Intent to Treat

Posted

Mean

Standard Deviation

Score on a scale

Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort

Other Pre-specified

Percentage of Participants With Mortality

All-cause, Cardiovascular, and Non-cardiovascular

Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Stroke

Disabling Stroke and Non-disabling Stroke

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Other Pre-specified

Percentage of Participants With Myocardial Infarction (MI)

Periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With Bleeding

Life-threatening (or disabling) and major (defined below)

Life-threatening or Disabling Bleeding

Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)
Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)

Major Bleeding (BARC type 3a)

Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized

Other Pre-specified

Percentage of Participants With Acute Kidney Injury

Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2

Change in serum creatinine (up to 7 days) compared to baseline:

Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)
Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline)
Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)

-OR-

Based on urine output (up to 7 days):

Stage 1: <0.5 ml/kg per hour for >6 but <12 hours
Stage 2: <0.5 ml/kg per hour for >12 but <24 hours
Stage 3: <0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours

Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.

Intent to Treat

Posted

Number

Percentage of participants

≤7 days post index procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Major Vascular Complication

Major vascular complication - including access site related and non access site related

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With Repeat Procedure for Valve-related Dysfunction

Repeat procedure for valve-related dysfunction (surgical or interventional therapy)

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure

Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With New Permanent Pacemaker Implantation

New permanent pacemaker implantation resulting from new or worsened conduction disturbances

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter

New onset of atrial fibrillation or atrial flutter

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003

Other Pre-specified

Percentage of Participants With Coronary Obstruction

Coronary obstruction

Intent to Treat

Posted

Number

Percentage of participants

≤72 hours post index procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Ventricular Septal Perforation

Ventricular septal perforation

Intent to Treat

Posted

Number

Percentage of participant

≤72 hours post index procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Other Pre-specified

Percentage of Participants With Mitral Apparatus Damage

Mitral apparatus damage

Intent to Treat

Posted

Number

Percentage of participants

≤72 hours post index procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Cardiac Tamponade

Cardiac tamponade

Intent to Treat

Posted

Number

Percentage of participants

≤72 hours post index procedure

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Prosthetic Aortic Valve Malpositioning

Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Other Pre-specified

Percentage of Participants With Prosthetic Aortic Valve Thrombosis

Prosthetic aortic valve thrombosis

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Other Pre-specified

Percentage of Participants With Prosthetic Aortic Valve Endocarditis

Prosthetic aortic valve endocarditis

Intent to Treat

Posted

Number

Percentage of participants

assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.

ID	Title	Description
OG000	Lotus Valve System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
OG003	Lotus Valve System - Single-arm Continued Access Cohort

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00027 events27 affected607 at risk EG0015 events5 affected305 at risk EG0024 events4 affected102 at risk EG0038 events8 affected295 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0019 events9 affected305 at risk EG0020 events0 affected102 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0011 events1 affected305 at risk EG0023 events3 affected102 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG000135 events135 affected607 at risk EG00137 events37 affected305 at risk EG00219 events19 affected102 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00075 events62 affected607 at risk EG00154 events38 affected305 at risk EG00214 events11 affected102 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00028 events28 affected607 at risk EG0017 events7 affected305 at risk EG0026 events6 affected102 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00022 events22 affected607 at risk EG0019 events9 affected305 at risk EG0028 events8 affected102 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00016 events16 affected607 at risk EG0014 events4 affected305 at risk EG0024 events3 affected102 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00015 events13 affected607 at risk EG0017 events7 affected305 at risk EG0021 events1 affected102 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00014 events14 affected607 at risk EG0019 events9 affected305 at risk EG0027 events7 affected102 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00013 events12 affected607 at risk EG0018 events8 affected305 at risk EG0020 events0 affected102 at risk EG003
Conduction disorder	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events12 affected607 at risk EG0018 events8 affected305 at risk EG0021 events1 affected102 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected607 at risk EG0013 events3 affected305 at risk EG0021 events1 affected102 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected607 at risk EG0015 events5 affected305 at risk EG0021 events1 affected102 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0018 events8 affected305 at risk EG0021 events1 affected102 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events3 affected607 at risk EG0014 events3 affected305 at risk EG0021 events1 affected102 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0013 events3 affected305 at risk EG0023 events3 affected102 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected607 at risk EG0011 events1 affected305 at risk EG0023 events2 affected102 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0022 events2 affected102 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0013 events3 affected305 at risk EG0021 events1 affected102 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Nodal rhythm	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Mitral perforation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Intracardiac thrombus	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Electromechanical dissociation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Myocardial rupture	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0015 events5 affected305 at risk EG0020 events0 affected102 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Sinus arrest	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0022 events2 affected102 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bradyarrhythmia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Mitral valve calcification	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Trifascicular block	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Ventricular asystole	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Peutz-Jeghers syndrome	Congenital, familial and genetic disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cataract	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Vision blurred	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events12 affected607 at risk EG0019 events9 affected305 at risk EG0025 events5 affected102 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected607 at risk EG0014 events4 affected305 at risk EG0020 events0 affected102 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Intestinal mass	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0014 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Rectal prolapse	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Diverticulum oesophageal	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Coeliac disease	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Oesophageal rupture	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0022 events2 affected102 at risk EG003
Fatigue	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected607 at risk EG0014 events4 affected305 at risk EG0020 events0 affected102 at risk EG003
Asthenia	General disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0011 events1 affected305 at risk EG0024 events4 affected102 at risk EG003
Adverse drug reaction	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
General physical health deterioration	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site necrosis	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0022 events2 affected102 at risk EG003
Pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site related reaction	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Sudden cardiac death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pyrexia	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Oedema peripheral	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Implant site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Implant site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Impaired healing	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hernia obstructive	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Multi-organ failure	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Mechanical complication of implant	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Alcoholic liver disease	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00025 events23 affected607 at risk EG00114 events13 affected305 at risk EG0024 events4 affected102 at risk EG003
Sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00018 events18 affected607 at risk EG0015 events5 affected305 at risk EG0021 events1 affected102 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00010 events10 affected607 at risk EG0019 events9 affected305 at risk EG0025 events4 affected102 at risk EG003
Septic shock	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0014 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0012 events2 affected305 at risk EG0024 events4 affected102 at risk EG003
Bronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Endocarditis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0012 events2 affected305 at risk EG0022 events2 affected102 at risk EG003
Urosepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 events3 affected607 at risk EG0011 events1 affected305 at risk EG0023 events3 affected102 at risk EG003
Catheter site infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Bronchiectasis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Osteomyelitis acute	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Clostridial infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Clostridium colitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Wound infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Device related infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Viral labyrinthitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastrointestinal bacterial infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cystitis klebsiella	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cystitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Lung infection pseudomonal	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gangrene	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pleural infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Fungal infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Appendicitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Implant site infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Ear infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemophilus infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Infected sebaceous cyst	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Influenza	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00026 events26 affected607 at risk EG00116 events16 affected305 at risk EG0024 events3 affected102 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00012 events12 affected607 at risk EG0014 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0015 events5 affected305 at risk EG0020 events0 affected102 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0013 events3 affected305 at risk EG0021 events1 affected102 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0013 events3 affected305 at risk EG0022 events2 affected102 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0014 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0023 events3 affected102 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lead dislodgement	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Drug toxicity	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Device failure	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Collapse of lung	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Brain herniation	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pacemaker complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Frostbite	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Renal injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Post procedural stroke	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Device dislocation	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Medical device complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0014 events4 affected305 at risk EG0020 events0 affected102 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Device malfunction	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Device lead damage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Urinary bladder rupture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Vascular pseudoaneurysm ruptured	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Echocardiogram abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
White blood cell count increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Urine cytology abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Troponin increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Occult blood positive	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
International normalised ratio increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Blood pressure systolic decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Blood pressure diastolic decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Blood lactic acid increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Blood culture positive	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Anticoagulation drug level below therapeutic	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Troponin I increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Sinus rhythm	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pulse absent	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Haematocrit decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Electrocardiogram QRS complex prolonged	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
C-reactive protein increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Blood pressure increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Clostridium difficile toxin test positive	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
International normalised ratio abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pedal pulse decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Troponin T increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events6 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0014 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Diabetic foot	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0022 events2 affected102 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Oral neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00021 events21 affected607 at risk EG00120 events20 affected305 at risk EG0025 events5 affected102 at risk EG003
Syncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00013 events13 affected607 at risk EG0019 events7 affected305 at risk EG0021 events1 affected102 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0014 events4 affected305 at risk EG0022 events1 affected102 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0015 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Dementia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Presyncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Partial seizures	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Chorea	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Multiple sclerosis	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Orthostatic intolerance	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Lethargy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Convulsion	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Brain stem syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Basal ganglia haemorrhage	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Aphasia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Hypoxic encephalopathy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Speech disorder	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Visual field defect	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Delirium	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0022 events2 affected102 at risk EG003
Delusion	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Aggression	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Polydipsia psychogenic	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG00033 events32 affected607 at risk EG00115 events15 affected305 at risk EG0025 events5 affected102 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0014 events4 affected305 at risk EG0021 events1 affected102 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0016 events5 affected305 at risk EG0026 events5 affected102 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0014 events4 affected305 at risk EG0024 events4 affected102 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Pelvic haematoma	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Vaginal disorder	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00018 events16 affected607 at risk EG0017 events7 affected305 at risk EG0021 events1 affected102 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00011 events11 affected607 at risk EG0015 events4 affected305 at risk EG0023 events3 affected102 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events10 affected607 at risk EG0015 events4 affected305 at risk EG0020 events0 affected102 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected607 at risk EG00113 events13 affected305 at risk EG0023 events3 affected102 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events6 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0010 events0 affected305 at risk EG0022 events1 affected102 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0011 events1 affected305 at risk EG0022 events2 affected102 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0022 events2 affected102 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0013 events3 affected305 at risk EG0020 events0 affected102 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0012 events2 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Precancerous skin lesion	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Activities of daily living impaired	Social circumstances	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events3 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0012 events2 affected305 at risk EG0022 events2 affected102 at risk EG003
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haematoma	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected607 at risk EG0013 events2 affected305 at risk EG0022 events1 affected102 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Iliac artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Labile blood pressure	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Arterial haemorrhage	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0012 events2 affected305 at risk EG0021 events1 affected102 at risk EG003
Arterial thrombosis limb	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Iliac artery thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Iliac artery occlusion	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Haemodynamic instability	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Femoral arterial stenosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0021 events1 affected102 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Extravasation blood	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Diabetic macroangiopathy	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0021 events1 affected102 at risk EG003
Arterial rupture	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Angiopathy	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0011 events1 affected305 at risk EG0020 events0 affected102 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Shock	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG000149 events146 affected607 at risk EG00143 events42 affected305 at risk EG00226 events26 affected102 at risk EG00369 events67 affected295 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00088 events86 affected607 at risk EG00156 events50 affected305 at risk EG00214 events13 affected102 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00038 events37 affected607 at risk EG00126 events25 affected305 at risk EG0020 events0 affected102 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG000229 events227 affected607 at risk EG00187 events83 affected305 at risk EG00240 events40 affected102 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00061 events58 affected607 at risk EG00130 events29 affected305 at risk EG00212 events11 affected102 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00053 events46 affected607 at risk EG00118 events18 affected305 at risk EG00213 events12 affected102 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00044 events44 affected607 at risk EG00124 events24 affected305 at risk EG0027 events6 affected102 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0026 events6 affected102 at risk EG003
Conduction disorder	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site haematoma	General disorders	MedDRA (12.1)	Systematic Assessment	EG00038 events38 affected607 at risk EG00124 events22 affected305 at risk EG0020 events0 affected102 at risk EG003
Oedema peripheral	General disorders	MedDRA (12.1)	Systematic Assessment	EG00030 events29 affected607 at risk EG00120 events18 affected305 at risk EG0020 events0 affected102 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (12.1)	Systematic Assessment	EG00029 events27 affected607 at risk EG00122 events21 affected305 at risk EG0020 events0 affected102 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00066 events62 affected607 at risk EG00137 events34 affected305 at risk EG00216 events15 affected102 at risk EG003
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0026 events6 affected102 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00031 events30 affected607 at risk EG00118 events17 affected305 at risk EG00211 events11 affected102 at risk EG003
Troponin increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0026 events6 affected102 at risk EG003
Echocardiogram abnormal	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00035 events35 affected607 at risk EG00119 events19 affected305 at risk EG0020 events0 affected102 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00031 events29 affected607 at risk EG00119 events17 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00029 events27 affected607 at risk EG00119 events18 affected305 at risk EG0020 events0 affected102 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0026 events6 affected102 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG00064 events55 affected607 at risk EG00142 events32 affected305 at risk EG0020 events0 affected102 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00041 events41 affected607 at risk EG00118 events18 affected305 at risk EG0026 events6 affected102 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0027 events7 affected102 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected607 at risk EG0010 events0 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00065 events61 affected607 at risk EG00137 events37 affected305 at risk EG0020 events0 affected102 at risk EG003
Hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00057 events56 affected607 at risk EG00120 events19 affected305 at risk EG00213 events13 affected102 at risk EG003

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 System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
BG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
BG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
BG003	Lotus Valve System - Single-arm Continued Access Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
BG004	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 System - Randomized	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)	70	587	431	607	458	607
EG001	CoreValve TAVR System - Randomized	Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)	40	297	207	305	210	305
EG002	Lotus Valve System - Single-arm Roll-in Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)	13	101	72	102	83	102
EG003	Lotus Valve System - Single-arm Continued Access Cohort	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)	27	293	229	295	228	295