Safety and Efficacy Study of the Medtronic CoreValve® Sys... | NCT01586910

Label	Type	Description	Intervention Names
Medtronic CoreValve® System TAVI	Experimental	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
SAVR	Active Comparator	Surgical Aortic Valve Replacement (SAVR)	Procedure: Surgical Aortic Valve Replacement (SAVR)

Name	Type	Description	Arm Group Labels	Other Names
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Device		Medtronic CoreValve® System TAVI
Surgical Aortic Valve Replacement (SAVR)

Measure	Description	Time Frame
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability	All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.	24 months

Measure	Description	Time Frame
Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	MACCE is defined as a composite of: All-cause death Myocardial infarction (MI) All stroke, and Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
Heart Team unanimously agree on treatment proposal and eligibility for randomization* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
Subject has severe aortic stenosis presenting with;
1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND
2. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:

Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
Ongoing sepsis, including active endocarditis;
Any condition considered a contraindication to extracorporeal assistance;
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization*;
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
Recent (within 6 months of randomization*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
Subject refuses a blood transfusion;
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
Currently participating in an investigational drug or another device trial (excluding registries);
Evidence of an acute myocardial infarction ≤30 days before the index procedure;
Need for emergency surgery for any reason;
True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
Extensive mediastinal radiation;
Liver failure (Child-C);
Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
Pulmonary Hypertension (systolic pressure> 80mmHg);
Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
Frailty assessments identify:
1. Subject is < 80 years of age and three or more of the following apply
2. Subject is ≥ 80 years of age and two or more of the following apply
  - Wheelchair bound
  - Resides in an institutional care facility (e.g., nursing home, skilled care center)
  - Body Mass Index < 20 kg/m2
  - Grip Strength < 16 kg
  - Katz Index Score ≤ 4
  - Albumin < 3.5 g/dL;
Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)

Note: Additional anatomical and vascular exclusion criteria may apply.

Note: * For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

Name	Affiliation	Role
Stephan Windecker, MD, PhD	Bern University Hospital	Principal Investigator
Rüdiger Lange, MD, PhD	Deutsches Herzzentrum München	Principal Investigator
Thomas Walther, MD, PhD	Kerckhoff Klinik	Principal Investigator
Michael J. Reardon, MD	The Methodist Hospital Research Institute	Principal Investigator
David H. Adams, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator
Nicolas M. Van Mieghem, MD	Erasmus Medical Center	Study Chair
Patrick W. Serruys, MD, PhD	National Heart & Lung Institute of Imperial College in London	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Banner Good Samaritan Medical Center		Phoenix	Arizona	85006	United States
Cedars-Sinai Medical Center

PubMed Identifier	Type	Citation	Retractions
38710669	Derived	Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.
38658126	Derived

ID	Title	Description
FG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
FG001	SAVR

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	May 31, 2016

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00012.6(10.2 to 15.3) OG00114.0(11.4 to 17.0)

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	Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.	Bayesian			The posterior probability of non-inferiority is > 0.9999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data using Bayes' Theorem.	Posterior Median of the Difference	-1.4			2-Sided						95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.

Secondary

Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

MACCE is defined as a composite of:

All-cause death
Myocardial infarction (MI)
All stroke, and
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

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

Posted

Number

percentage of participants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants

Secondary

Percentage of Participants With Individual MACCE Components

MACCE is defined as a composite of:

All-cause death
Myocardial infarction (MI)
All stroke, and
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

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

Posted

Number

percentage of participants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Major Adverse Events (MAE)

Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.

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

Posted

Number

percentage of participants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants

Secondary

Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation

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

Posted

Number

percentage of participants

30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Change in NYHA Class From Baseline

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

New York Heart Association (NYHA) Classification:

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

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

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

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

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

Posted

Mean

Standard Deviation

units on a scale

Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units

Secondary

Change in Distance Walked During 6-minute Walk Test (6MWT)

Change in distance walked during 6MWT from baseline

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

Posted

Mean

Standard Deviation

meters

From baseline to 30 days, baseline to 12 months, and baseline to 24 months

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Ratio of Days Alive Out of Hospital Versus Total Days Alive

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

Posted

Mean

Standard Deviation

ratio

12 and 24 months

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Quality of Life (QoL) Change From Baseline

QoL summary score change from baseline using the following measures:

Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.

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

Posted

Mean

Standard Deviation

units on a scale

Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Secondary

Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance

Using the following measure:

-Transvalvular mean gradient

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

Posted

Mean

Standard Deviation

mmHg

discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Effective Orifice Area as an Assessment of Prosthetic Valve Performance

Using the following measure:

-Effective Orifice Area (cm^2)

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

Posted

Mean

Standard Deviation

cm^2

discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance

Using the following measure:

- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)

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

Posted

Number

Percentage of participants

discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Aortic Valve Disease Related Hospitalizations

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

Posted

Number

percentage of particpants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths

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

Posted

Number

percentage of participants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Stroke and TIAs

Strokes (of any severity) and Transient Ischemic Attacks (TIAs)

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

Posted

Number

percentage of participants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Peri-procedural Neurological Injury

Neurological injury (stroke, TIA, or encephalopathy)

Participant Population= Consisted of all randomized subjects with an index procedure

Posted

Number

percentage of participants

discharge or 7 days post index procedure (whichever occurred first)

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Index Procedure Related Major Adverse Events (MAEs)

Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.

Participant Population= Consisted of all randomized subjects with an index procedure

Posted

Number

percentage of participants

Procedure through 30 day visit

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Length of Index Procedure Hospital Stay

Participant Population= Consisted of all randomized subjects with an index procedure

Posted

Mean

Standard Deviation

days

Number of days from admission to discharge (expected average of 7 days)

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Presence of Atrial Fibrillation

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

Posted

Number

percentage of participants

post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Device Success (Medtronic CoreValve® System Subjects Only)

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

Participant Population =Consisted of all randomized subjects with a TAVR index procedure who were evaluable for device success.

Posted

Number

percentage of participants

Number of days from admission to discharge (expected average of 7 days)

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts
Participants	OG000

Secondary

Procedural Success (Medtronic CoreValve® System Subjects Only)

Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)

Participant Population= Consisted of all randomized subjects with a TAVR index procedure who were evaluable for procedural success.

Posted

Number

percentage of participants

Number of days from admission to discharge (expected average of 7 days)

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts
Participants	OG000

Secondary

Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)

Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered

PVD defined as:

Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA <1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI <0. 35 m/s) OR
moderate or severe total AR

Participant Population= Consisted of all subjects with a valve implanted

Posted

Number

percentage of participants

6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts

Secondary

Percentage of Participants With Early Safety Endpoint

Percentage of participants with VARC II early safety composite at 30 days

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

Posted

Number

percentage of participants

30 Days

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Clinical Efficacy (After 30 Days)

Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.

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

Posted

Number

percentage of participants

6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Time-Related Safety

The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI <0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.

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

Posted

Number

percentage of participants

30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
OG001	SAVR	Surgical Aortic Valve Replacement (SAVR)

Units	Counts
Participants

Secondary

Resheath and Recapture Success (Evolut R Only)

The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.

Participant Population= Consisted of all subjects in whom the resheath or recapture feature of the Evolut R system was attempted

Posted

Number

percentage of attempts

Procedure

attempts

ID	Title	Description
OG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000117 events102 affected864 at risk EG001222 events203 affected796 at risk
AUTOIMMUNE HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
BLOOD DISORDER	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG00111 events11 affected796 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAEMORRHAGIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00040 events40 affected864 at risk EG00187 events84 affected796 at risk
HYPOCHROMIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG0012 events2 affected796 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0018 events7 affected796 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0016 events6 affected796 at risk
SPLENIC HAEMATOMA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected864 at risk EG00145 events44 affected796 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected864 at risk EG00115 events9 affected796 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected864 at risk EG00119 events19 affected796 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected864 at risk EG0015 events4 affected796 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0013 events3 affected796 at risk
AORTIC VALVE DISEASE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00046 events43 affected864 at risk EG0015 events5 affected796 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0015 events4 affected796 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG000105 events86 affected864 at risk EG001185 events169 affected796 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected864 at risk EG00119 events19 affected796 at risk
ATRIAL RUPTURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0014 events4 affected796 at risk
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00018 events18 affected864 at risk EG0015 events5 affected796 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG000157 events157 affected864 at risk EG00144 events44 affected796 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00016 events16 affected864 at risk EG0012 events2 affected796 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00018 events17 affected864 at risk EG0016 events6 affected796 at risk
ATRIOVENTRICULAR DISSOCIATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
BRADYARRHYTHMIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00027 events27 affected864 at risk EG00118 events17 affected796 at risk
BUNDLE BRANCH BLOCK	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00058 events58 affected864 at risk EG0011 events1 affected796 at risk
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected864 at risk EG0013 events3 affected796 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00021 events21 affected864 at risk EG00115 events15 affected796 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00028 events21 affected864 at risk EG00127 events21 affected796 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected864 at risk EG0016 events6 affected796 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG000104 events82 affected864 at risk EG00174 events61 affected796 at risk
CARDIAC PERFORATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00013 events12 affected864 at risk EG0011 events1 affected796 at risk
CARDIAC SEPTAL HYPERTROPHY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected864 at risk EG0019 events9 affected796 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0015 events5 affected796 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected864 at risk EG00132 events32 affected796 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
CARDIORENAL SYNDROME	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CARDIOVASCULAR DECONDITIONING	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
CHRONOTROPIC INCOMPETENCE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CONDUCTION DISORDER	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
COR PULMONALE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0015 events5 affected796 at risk
CORONARY ARTERY EMBOLISM	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
CORONARY OSTIAL STENOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DEFECT CONDUCTION INTRAVENTRICULAR	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DIASTOLIC DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
EXTRASYSTOLES	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
INTRAPERICARDIAL THROMBOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0015 events5 affected796 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0014 events4 affected796 at risk
LOW CARDIAC OUTPUT SYNDROME	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0014 events4 affected796 at risk
MITRAL VALVE CALCIFICATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
MITRAL VALVE DISEASE MIXED	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected864 at risk EG0016 events6 affected796 at risk
MITRAL VALVE STENOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
NODAL ARRHYTHMIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
NODAL RHYTHM	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0016 events6 affected796 at risk
PALPITATIONS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
PARAVALVULAR AORTIC REGURGITATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG0010 events0 affected796 at risk
PAROXYSMAL ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected864 at risk EG00116 events15 affected796 at risk
PERICARDIAL HAEMORRHAGE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
PERICARDITIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0015 events5 affected796 at risk
PROSTHETIC CARDIAC VALVE THROMBOSIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
PULMONARY VALVE INCOMPETENCE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PULSELESS ELECTRICAL ACTIVITY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
RHYTHM IDIOVENTRICULAR	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
RIGHT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
RIGHT VENTRICULAR ENLARGEMENT	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RIGHT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
SINUS ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected864 at risk EG00110 events9 affected796 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG0015 events5 affected796 at risk
SYSTOLIC DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0013 events3 affected796 at risk
TORSADE DE POINTES	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TRICUSPID VALVE INCOMPETENCE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected864 at risk EG00112 events12 affected796 at risk
TRIFASCICULAR BLOCK	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VENTRICULAR ASYSTOLE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0017 events7 affected796 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00017 events15 affected864 at risk EG00116 events15 affected796 at risk
HAEMOPHILIA	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
CERUMEN IMPACTION	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
MIDDLE EAR INFLAMMATION	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0012 events2 affected796 at risk
GOITRE	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HYPERPARATHYROIDISM PRIMARY	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
AMAUROSIS FUGAX	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CATARACT	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected864 at risk EG0019 events7 affected796 at risk
CATARACT NUCLEAR	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CHARLES BONNET SYNDROME	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DIABETIC RETINAL OEDEMA	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DIPLOPIA	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
GLAUCOMA	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
MACULAR FIBROSIS	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OPEN ANGLE GLAUCOMA	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OPTIC ISCHAEMIC NEUROPATHY	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RETINAL ARTERY OCCLUSION	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VISION BLURRED	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
VISUAL IMPAIRMENT	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0014 events4 affected796 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
ABDOMINAL WALL HAEMATOMA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
ANAL INCONTINENCE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ASCITES	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0010 events0 affected796 at risk
COLITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events3 affected796 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0017 events7 affected796 at risk
DIVERTICULAR PERFORATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0014 events4 affected796 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DUODENAL ULCER PERFORATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DYSKINESIA OESOPHAGEAL	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected864 at risk EG00122 events22 affected796 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00028 events24 affected864 at risk EG00134 events28 affected796 at risk
GASTROINTESTINAL ULCER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
ILEUS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
INCARCERATED INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
INCARCERATED UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0013 events3 affected796 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0012 events2 affected796 at risk
INTESTINAL MASS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LARGE INTESTINAL STENOSIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected864 at risk EG0011 events1 affected796 at risk
LOOSE TOOTH	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected864 at risk EG0013 events3 affected796 at risk
MELAENA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0014 events4 affected796 at risk
MESENTERIC ARTERY STENOSIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
ODYNOPHAGIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OESOPHAGEAL DISORDER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
OESOPHAGEAL PERFORATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OESOPHAGEAL RUPTURE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
OESOPHAGEAL STENOSIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
PERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PERITONEAL LESION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PNEUMOPERITONEUM	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
RECTAL PROLAPSE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RECTOURETHRAL FISTULA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RETROPERITONEAL HAEMATOMA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
SALIVARY GLAND MASS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
SWOLLEN TONGUE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0014 events4 affected796 at risk
VOLVULUS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0014 events4 affected796 at risk
ADVERSE DRUG REACTION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected864 at risk EG0019 events7 affected796 at risk
CATHETER SITE DISCHARGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
CATHETER SITE HAEMATOMA	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CHEST DISCOMFORT	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG00020 events18 affected864 at risk EG00118 events17 affected796 at risk
COMPLICATION ASSOCIATED WITH DEVICE	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
COMPLICATION OF DEVICE INSERTION	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0014 events4 affected796 at risk
DEVICE EMBOLISATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
DRUG WITHDRAWAL SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
EFFUSION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
GAIT DISTURBANCE	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0011 events1 affected796 at risk
GENERALISED OEDEMA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HERNIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPOTHERMIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
IMPAIRED HEALING	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
IMPLANT SITE DISCHARGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
IMPLANT SITE EROSION	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MALAISE	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0015 events5 affected796 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG00113 events12 affected796 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG00112 events11 affected796 at risk
PERIPHERAL SWELLING	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POLYP	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
PUNCTURE SITE HAEMORRHAGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0018 events8 affected796 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
SUDDEN DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0016 events6 affected796 at risk
ULCER HAEMORRHAGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VASCULAR STENT STENOSIS	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VASCULAR STENT THROMBOSIS	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ACUTE HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0014 events4 affected796 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0015 events5 affected796 at risk
CHRONIC HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
GALLBLADDER DISORDER	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ISCHAEMIC HEPATITIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
LIVER DISORDER	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LIVER INJURY	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected864 at risk EG0010 events0 affected796 at risk
ABSCESS JAW	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
APPENDICITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00013 events12 affected864 at risk EG0014 events4 affected796 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0015 events5 affected796 at risk
CAMPYLOBACTER SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CARDIAC VALVE ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CATHETER SITE CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00017 events16 affected864 at risk EG00115 events15 affected796 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0015 events5 affected796 at risk
CYSTITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
CYTOMEGALOVIRUS VIRAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected864 at risk EG0010 events0 affected796 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DEVICE RELATED SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0010 events0 affected796 at risk
EMPYEMA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
ENCEPHALITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ENCEPHALITIS VIRAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0018 events8 affected796 at risk
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ENTEROBACTER SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ENTEROCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected864 at risk EG0010 events0 affected796 at risk
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
EPIDIDYMITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FUNGAL OESOPHAGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
GANGRENE	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
GASTROINTESTINAL VIRAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
GROIN INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
HAEMOPHILUS SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HELICOBACTER INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
INCISION SITE CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
INFECTED SEROMA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events1 affected796 at risk
INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
INFLUENZA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
LABYRINTHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LARYNGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LIVER ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
LUNG INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
LYME DISEASE	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
MEDIASTINITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
NASAL ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ORCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0017 events4 affected796 at risk
OSTEOMYELITIS ACUTE	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events2 affected796 at risk
PERITONITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00065 events58 affected864 at risk EG00160 events55 affected796 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected864 at risk EG0012 events2 affected796 at risk
PNEUMONIA CYTOMEGALOVIRAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PNEUMONIA HAEMOPHILUS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PNEUMONIA KLEBSIELLA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POST PROCEDURAL PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG00119 events13 affected796 at risk
PSEUDOMONAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PSEUDOMONAS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PULMONARY SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0015 events5 affected796 at risk
SALMONELLA BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00028 events24 affected864 at risk EG00125 events24 affected796 at risk
SEPTIC ENCEPHALOPATHY	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0016 events5 affected796 at risk
SINUSITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
SKIN CANDIDA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SPINAL CORD INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
STREPTOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0010 events0 affected796 at risk
TRACHEOBRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00041 events33 affected864 at risk EG00126 events25 affected796 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
UROSEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected864 at risk EG00112 events12 affected796 at risk
VASCULAR ACCESS SITE INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
VIRAL CARDIOMYOPATHY	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
WOUND INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0014 events4 affected796 at risk
ABDOMINAL INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected864 at risk EG0010 events0 affected796 at risk
ALLERGIC TRANSFUSION REACTION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected864 at risk EG00136 events36 affected796 at risk
ANASTOMOTIC HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
AORTIC INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ARTERIAL BYPASS OCCLUSION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ARTERIAL INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0011 events1 affected796 at risk
BRACHIAL PLEXUS INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CARBON MONOXIDE POISONING	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CARDIAC VALVE RUPTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
CARDIAC VEIN PERFORATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
COMPLICATIONS OF TRANSPLANTED HEART	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CORNEAL ABRASION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DEVICE DEPLOYMENT ISSUE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00025 events24 affected864 at risk EG0010 events0 affected796 at risk
EXTRADURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00014 events13 affected864 at risk EG0019 events9 affected796 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
FOREARM FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
FOREIGN BODY IN EAR	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAEMODILUTION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
HEART INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected864 at risk EG00110 events10 affected796 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected864 at risk EG0011 events1 affected796 at risk
INCISION SITE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
INCISION SITE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0010 events0 affected796 at risk
INCISIONAL HERNIA, OBSTRUCTIVE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0012 events2 affected796 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0016 events6 affected796 at risk
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0011 events1 affected796 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
MENISCUS INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
NERVE INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PERIPROCEDURAL MYOCARDIAL INFARCTION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POST LAMINECTOMY SYNDROME	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG00120 events19 affected796 at risk
POSTOPERATIVE DELIRIUM	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
POSTOPERATIVE ILEUS	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0014 events4 affected796 at risk
POSTOPERATIVE RESPIRATORY FAILURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0014 events4 affected796 at risk
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
POSTOPERATIVE THROMBOSIS	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
POSTPERICARDIOTOMY SYNDROME	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0019 events9 affected796 at risk
PROCEDURAL HYPERTENSION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0011 events1 affected796 at risk
PROCEDURAL PNEUMOTHORAX	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0016 events6 affected796 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
SEROMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
SUBARACHNOID HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0010 events0 affected796 at risk
SUBCUTANEOUS HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0012 events2 affected796 at risk
SUTURE RELATED COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
TOOTH FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TRAUMATIC LUNG INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
URETERIC INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
URINARY RETENTION POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
VASCULAR ACCESS COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
VASCULAR ACCESS SITE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected864 at risk EG0010 events0 affected796 at risk
VASCULAR ACCESS SITE HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
VASCULAR ACCESS SITE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG0012 events2 affected796 at risk
VASOPLEGIA SYNDROME	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VENOUS INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
WEANING FAILURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
WOUND SECRETION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected864 at risk EG0011 events1 affected796 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0012 events2 affected796 at risk
XIITH NERVE INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0015 events5 affected796 at risk
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
BLOOD CULTURE POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
BLOOD ERYTHROPOIETIN DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BLOOD FIBRINOGEN DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BLOOD GLUCOSE DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BLOOD GLUCOSE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BLOOD POTASSIUM ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BODY TEMPERATURE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BRAIN NATRIURETIC PEPTIDE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CALCIUM IONISED DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CARDIAC INDEX DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
CARDIAC INDEX INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CARDIAC MURMUR	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CARDIAC OUTPUT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0019 events9 affected796 at risk
CARDIOVASCULAR FUNCTION TEST NORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
COAGULATION TIME PROLONGED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
CYSTOSCOPY ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ECHOCARDIOGRAM ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0013 events3 affected796 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
ELECTROCARDIOGRAM ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FIBRIN D DIMER INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FUNGAL TEST POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAEMATOCRIT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0015 events5 affected796 at risk
INTERNATIONAL NORMALISED RATIO ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0015 events5 affected796 at risk
INVESTIGATION	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
NUTRITIONAL CONDITION ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OCCULT BLOOD	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OCCULT BLOOD POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
OXYGEN SATURATION DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PULMONARY ARTERIAL PRESSURE ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PULSE ABSENT	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
TROPONIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0011 events1 affected796 at risk
URINE OUTPUT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0013 events3 affected796 at risk
VENOUS OXYGEN SATURATION ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
WEIGHT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
WEIGHT INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
ABNORMAL LOSS OF WEIGHT	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
ACIDOSIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
CALCIPHYLAXIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected864 at risk EG0015 events5 affected796 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG0011 events1 affected796 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00014 events13 affected864 at risk EG00129 events29 affected796 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected864 at risk EG00114 events14 affected796 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0017 events7 affected796 at risk
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPERVOLAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0012 events2 affected796 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0019 events8 affected796 at risk
HYPOMAGNEseriousMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected864 at risk EG00118 events16 affected796 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG00117 events17 affected796 at risk
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MALNUTRITION	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0019 events9 affected796 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0014 events4 affected796 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0013 events3 affected796 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected864 at risk EG0014 events4 affected796 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
EXOSTOSIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FISTULA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
JAW CYST	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0011 events1 affected796 at risk
MUSCLE HAEMORRHAGE	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0011 events1 affected796 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00017 events16 affected864 at risk EG00112 events12 affected796 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
PLANTAR FASCIITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
SACROILIITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SPINAL COLUMN STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SPONDYLOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SYNOVIAL CYST	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TEMPOROMANDIBULAR JOINT SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
TENOSYNOVITIS STENOSANS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
TRIGGER FINGER	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0017 events7 affected796 at risk
BASOSQUAMOUS CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BENIGN BONE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0016 events6 affected796 at risk
BLADDER CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
BONE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0010 events0 affected796 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0013 events3 affected796 at risk
CHRONIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0014 events4 affected796 at risk
COLORECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
GALLBLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
GASTROINTESTINAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
GASTROINTESTINAL STROMAL TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LENTIGO MALIGNA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LIPOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
MALIGNANT NEOPLASM OF SPERMATIC CORD	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MELANOCYTIC NAEVUS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
OVARIAN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
OVARIAN CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PLASMA CELL MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0012 events2 affected796 at risk
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RENAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0012 events2 affected796 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0015 events5 affected796 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
AMNESIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
APHASIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
BRAIN INJURY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BRAIN OEDEMA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CAROTID ARTERY DISEASE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CAROTID ARTERY OCCLUSION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0014 events4 affected796 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected864 at risk EG0011 events1 affected796 at risk
CEREBELLAR HAEMORRHAGE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
CEREBRAL ATROPHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0017 events7 affected796 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00025 events24 affected864 at risk EG00131 events30 affected796 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
COMA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DEMENTIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DEMENTIA ALZHEIMER'S TYPE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
DIZZINESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected864 at risk EG0013 events3 affected796 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
EMBOLIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0017 events6 affected796 at risk
EPILEPSY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
GENERALISED TONIC-CLONIC SEIZURE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0015 events5 affected796 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
HEADACHE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
HEMIANOPIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HYDROCEPHALUS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPERREFLEXIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
IIIRD NERVE PARALYSIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0018 events8 affected796 at risk
LACUNAR INFARCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LETHARGY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0017 events7 affected796 at risk
MIGRAINE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
NEURALGIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
OPTIC NEURITIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PARKINSON'S DISEASE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
PERONEAL NERVE PALSY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00012 events9 affected864 at risk EG0014 events4 affected796 at risk
SEIZURE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
SEIZURE LIKE PHENOMENA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SENSORY DISTURBANCE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SEROTONIN SYNDROME	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SYNCOPE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00024 events24 affected864 at risk EG00120 events19 affected796 at risk
TOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00025 events25 affected864 at risk EG00110 events10 affected796 at risk
TREMOR	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
UNRESPONSIVE TO STIMULI	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
VERTEBROBASILAR INSUFFICIENCY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VOCAL CORD PARALYSIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DEVICE ADHESION ISSUE	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
DEVICE CAPTURING ISSUE	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DEVICE DISLOCATION	Product Issues	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
DEVICE FAILURE	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DEVICE ISSUE	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DEVICE LEAD ISSUE	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
DEVICE LEAKAGE	Product Issues	MedDRA 21.0	Systematic Assessment	EG00030 events28 affected864 at risk EG0012 events2 affected796 at risk
DEVICE LOOSENING	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DEVICE MALFUNCTION	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
DEVICE PACING ISSUE	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LEAD DISLODGEMENT	Product Issues	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0012 events2 affected796 at risk
ADJUSTMENT DISORDER	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
AFFECTIVE DISORDER	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events1 affected796 at risk
AGITATION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
ANXIETY	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0015 events5 affected796 at risk
DELIRIUM	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG00116 events15 affected796 at risk
DELIRIUM TREMENS	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
DEPRESSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DEPRESSION SUICIDAL	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
HALLUCINATION, AUDITORY	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HALLUCINATION, VISUAL	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00013 events13 affected864 at risk EG0018 events8 affected796 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00075 events62 affected864 at risk EG00195 events82 affected796 at risk
ANURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
AZOTAEMIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BLADDER OBSTRUCTION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0014 events4 affected796 at risk
DYSURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
END STAGE RENAL DISEASE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected864 at risk EG0011 events1 affected796 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00025 events22 affected864 at risk EG00118 events15 affected796 at risk
HAEMORRHAGE URINARY TRACT	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
INCONTINENCE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0013 events2 affected796 at risk
OLIGURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0012 events2 affected796 at risk
POLYURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RENAL ARTERY OCCLUSION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected864 at risk EG00113 events13 affected796 at risk
RENAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RENAL MASS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RENAL TUBULAR DISORDER	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
STAG HORN CALCULUS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
URETEROLITHIASIS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
URETHRAL OBSTRUCTION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
URINARY BLADDER HAEMORRHAGE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00032 events29 affected864 at risk EG00121 events21 affected796 at risk
URINE FLOW DECREASED	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ACQUIRED PHIMOSIS	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
PENILE OEDEMA	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PENILE PAIN	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
ACUTE LUNG INJURY	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected864 at risk EG0011 events1 affected796 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00015 events13 affected864 at risk EG00116 events16 affected796 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0014 events4 affected796 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG00111 events10 affected796 at risk
CHOKING SENSATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 events13 affected864 at risk EG00121 events16 affected796 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0012 events2 affected796 at risk
DEPENDENCE ON RESPIRATOR	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00025 events22 affected864 at risk EG00111 events11 affected796 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0014 events4 affected796 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG00110 events10 affected796 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0018 events8 affected796 at risk
HYPERCAPNIA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected864 at risk EG0018 events8 affected796 at risk
LARYNGEAL ATROPHY	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LARYNGEAL STENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
MEDIASTINAL HAEMATOMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
MEDIASTINAL HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0018 events8 affected796 at risk
MEDIASTINAL MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
NASAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00043 events38 affected864 at risk EG001123 events102 affected796 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected864 at risk EG0018 events8 affected796 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected864 at risk EG00118 events18 affected796 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected864 at risk EG00110 events10 affected796 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0011 events1 affected796 at risk
PULMONARY HAEMATOMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected864 at risk EG00111 events11 affected796 at risk
RESPIRATORY ACIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0015 events5 affected796 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG00111 events11 affected796 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00030 events27 affected864 at risk EG00156 events50 affected796 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0011 events1 affected796 at risk
ACTINIC KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
DIABETIC ULCER	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PANNICULITIS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SKIN FISSURES	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
SUBCUTANEOUS EMPHYSEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
CARDIAC PACEMAKER BATTERY REPLACEMENT	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CARDIAC PACEMAKER REPLACEMENT	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
CATARACT OPERATION	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0015 events4 affected796 at risk
CHOLECYSTECTOMY	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
COLOSTOMY CLOSURE	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
EAR OPERATION	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HERNIA REPAIR	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
HIP ARTHROPLASTY	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0010 events0 affected796 at risk
IMPLANTABLE DEFIBRILLATOR REPLACEMENT	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
KNEE ARTHROPLASTY	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
PREVENTIVE SURGERY	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ROTATOR CUFF REPAIR	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
SPINAL FUSION SURGERY	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
TRANSFUSION	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
WOUND DRAINAGE	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
WOUND TREATMENT	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ANEURYSM	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0011 events1 affected796 at risk
AORTIC ARTERIOSCLEROSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected864 at risk EG0010 events0 affected796 at risk
AORTIC RUPTURE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0013 events3 affected796 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ARTERIAL RUPTURE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
ARTERIOVENOUS FISTULA	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0014 events4 affected796 at risk
ARTERY DISSECTION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
BRACHIOCEPHALIC VEIN THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected864 at risk EG00111 events11 affected796 at risk
DRY GANGRENE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
FEMORAL ARTERY DISSECTION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected864 at risk EG0012 events2 affected796 at risk
FEMORAL ARTERY EMBOLISM	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
FEMORAL ARTERY PERFORATION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
HAEMATOMA	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00024 events24 affected864 at risk EG0015 events5 affected796 at risk
HAEMODYNAMIC INSTABILITY	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0013 events3 affected796 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected864 at risk EG00120 events20 affected796 at risk
HYPERTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00035 events34 affected864 at risk EG00132 events29 affected796 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected864 at risk EG0013 events3 affected796 at risk
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00052 events51 affected864 at risk EG00189 events87 affected796 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG00110 events10 affected796 at risk
ILIAC ARTERY PERFORATION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ILIAC ARTERY RUPTURE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
LABILE BLOOD PRESSURE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected864 at risk EG0010 events0 affected796 at risk
LYMPHOCELE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
MALIGNANT HYPERTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
NECROSIS ISCHAEMIC	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected864 at risk EG0017 events7 affected796 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0012 events2 affected796 at risk
PERIPHERAL ARTERY DISSECTION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected864 at risk EG0010 events0 affected796 at risk
PERIPHERAL ARTERY OCCLUSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected864 at risk EG0010 events0 affected796 at risk
PERIPHERAL ARTERY STENOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected864 at risk EG0013 events3 affected796 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected864 at risk EG0013 events2 affected796 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected864 at risk EG0012 events2 affected796 at risk
PERIPHERAL VENOUS DISEASE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected864 at risk EG0011 events1 affected796 at risk
SHOCK	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0017 events7 affected796 at risk
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0012 events2 affected796 at risk
SUBCLAVIAN ARTERY THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
SUBCLAVIAN VEIN THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk
THROMBOPHLEBITIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0012 events2 affected796 at risk
VARICOSE VEIN	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG0011 events1 affected796 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected864 at risk EG0010 events0 affected796 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00084 events80 affected864 at risk EG001100 events99 affected796 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00071 events70 affected864 at risk EG001154 events146 affected796 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000140 events133 affected864 at risk EG001198 events188 affected796 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG000120 events112 affected864 at risk EG001239 events230 affected796 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00082 events80 affected864 at risk EG00168 events67 affected796 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG000265 events258 affected864 at risk EG00159 events55 affected796 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG00156 events53 affected796 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG00143 events42 affected796 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG00048 events45 affected864 at risk EG00149 events47 affected796 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00077 events65 affected864 at risk EG001102 events88 affected796 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG001127 events122 affected796 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00054 events53 affected864 at risk EG001102 events102 affected796 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG00142 events41 affected796 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00049 events46 affected864 at risk EG00155 events53 affected796 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG00156 events52 affected796 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected864 at risk EG00147 events44 affected796 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00091 events79 affected864 at risk EG001138 events125 affected796 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00064 events62 affected864 at risk EG001154 events151 affected796 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00050 events48 affected864 at risk EG0010 events0 affected796 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00076 events70 affected864 at risk EG001223 events216 affected796 at risk
HAEMATOMA	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00049 events47 affected864 at risk EG0010 events0 affected796 at risk
HYPERTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG000139 events123 affected864 at risk EG001107 events100 affected796 at risk
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00050 events47 affected864 at risk EG00183 events82 affected796 at risk

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

ID	Title	Description
BG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
BG001	SAVR	Surgical Aortic Valve Replacement (SAVR)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Medtronic CoreValve® System TAVI	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	98	864	718	864	803	864
EG001	SAVR	Surgical Aortic Valve Replacement (SAVR)	80	796	694	796	754	796