Adaptive Cardiac Resynchronization Therapy Study | NCT00980057

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adaptive CRT (aCRT) arm	Experimental	Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON	Device: Adaptive CRT (aCRT)
Echo-optimized arm	Active Comparator	Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)	Device: Echo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adaptive CRT (aCRT)	Device	Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score	Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse	randomization to six month visit
Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings	Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.	randomization visit and six month visit
Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)	For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (>60 ms)	randomization to 6 months post randomization

Secondary Outcomes

Measure	Description	Time Frame
Right Ventricular Pacing Percentage	The percentage of time the right ventricle is paced by the device	implant to six months post randomization
Change in Left Ventricular End Systolic Volume Index (LVESVi)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is willing to sign and date the study Informed Consent form
Subject is at least 18 years of age (or older, if required by local law)
Subject is expected to remain available for at least six months of follow-up visits
Subject is indicated for a study device that will be implanted within 30 days after signing the Informed Consent form
Subject has an intrinsic QRS duration greater than or equal to 120 milliseconds (documented within 30 days prior to enrollment)
Subject has a left ventricular ejection fraction less than or equal to 35 percent (method per physician discretion) (documented within 180 days prior to enrollment)
Subject is diagnosed with New York Heart Association (NYHA) class III or IV (within 30 days prior to enrollment) despite optimal medical therapy which is defined as: ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least one month prior to implant, AND beta-blocker for at least three months preceding implant, if tolerated, and stable for one month, OR subject has an urgent medical need for an implantable cardioverter defibrillator (ICD) that precludes waiting the one or three months for the medication requirements for ACE inhibitor, ARB or beta-blocker

Exclusion Criteria:

Subject has chronic (permanent) atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
Subject has existing CRT system
Subject has non-intact or unstable leads
Subject has medical conditions that would limit study participation (per physician discretion)
Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) (documented within 30 days prior to enrollment)
Subject has a mechanical right heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study
Subject is post-heart transplant (subjects on the heart transplant list for the first time are not excluded)
Subject has a limited life expectancy that would not allow completion of the 6 month visit
Subject is pregnant (In the United States, all women of child-bearing potential must undergo a pregnancy test within seven days prior to aCRT download into device)
Subject meets the exclusion criteria required by local law

Name	Affiliation	Role
Adaptive CRT Trial Leader	Medtronic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama	36264	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30991823	Derived	Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.
28893549

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
BG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.4± 11.2 BG00166.2± 9.7 BG00265.7± 10.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00097 BG00151 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0008 BG0013 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Russia

Title	Measurements
	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score

Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant

Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse

Posted

Count of Participants

Participants

randomization to six month visit

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Units	Counts
Participants	OG000318 OG001160

Title

Denominators

Categories

Title	Measurements
	OG000234 OG001114

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Farrington-Manning test of two ind. prop		0.0002														Non-Inferiority	The non-inferiority margin was 12%.

Primary

Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings

Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.

Concordance correlations have been calculated between AoVTI at Adaptive CRT AV and VV settings vs. echo-optimized AV and VV settings at randomization and 6 M. Paired AoVTI measurements were used for concordance correlation analysis, where each subject served as his/her own control. AoVTI was not obtained at both settings for 79 patients.

Posted

Number

95% Confidence Interval

Concordance correlation coefficient

randomization visit and six month visit

ID	Title	Description
OG000	All Randomized Patients	The AoVTI was calculated for each Adaptive CRT subject under two different parameter settings: AV and VV settings determined by Adaptive CRT, and AV and VV settings determined by echo-optimization. Subsequently a concordance correlation was calculated and reported, thus this measure cannot be reported per treatment arm.

Units	Counts
Participants	OG000

Primary

Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)

For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (>60 ms)

17 participants did not have data available for analysis of this endpoint.

Posted

Count of Participants

Participants

randomization to 6 months post randomization

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status

Units	Counts
Participants	OG000

Secondary

Right Ventricular Pacing Percentage

The percentage of time the right ventricle is paced by the device

Posted

Mean

Standard Deviation

percentage of right ventricle pacing

implant to six months post randomization

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Units	Counts
Participants

Secondary

Change in Left Ventricular End Systolic Volume Index (LVESVi)

Change in left ventricular end systolic volume index (LVESVi).

Posted

Mean

Standard Deviation

milliliters per meter squared

baseline to six month visit

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Units	Counts
Participants

Secondary

Change in Left Ventricular Ejection Fraction (LVEF)

Posted

Mean

Standard Deviation

percent

baseline to six month visit

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Units	Counts
Participants	OG000

Secondary

Change in New York Heart Association (NYHA) Classification

The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity.

Class - Patient Symptoms I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

IV- Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Posted

Mean

Standard Deviation

NYHA class

baseline to six month visit

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Secondary

Change in Distance Walked During the Six Minute Hall Walk

Posted

Mean

Standard Deviation

meters

baseline to six month visit

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Units	Counts
Participants	OG000

Secondary

Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)

The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.

Posted

Mean

Standard Deviation

units on a scale

baseline to six month visit

ID	Title	Description
OG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
OG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Adaptive CRT (aCRT) Pacing	Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status	35	318	158	318	50	318
EG001	Standard Biventricular Pacing	Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)	19	160	86	160	34	160

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0016 events6 affected160 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0012 events2 affected160 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected318 at risk EG0011 events1 affected160 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected318 at risk EG0018 events5 affected160 at risk
Atrial flutter	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected318 at risk EG0010 events0 affected160 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0011 events1 affected160 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG000112 events63 affected318 at risk EG00158 events35 affected160 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected318 at risk EG0010 events0 affected160 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0013 events3 affected160 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected318 at risk EG0010 events0 affected160 at risk
Pericardial effusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected318 at risk EG0010 events0 affected160 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Tricuspid valve disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0011 events1 affected160 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected318 at risk EG0016 events4 affected160 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cataract	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Colitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0012 events2 affected160 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0015 events4 affected160 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0012 events1 affected160 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected318 at risk EG0014 events4 affected160 at risk
Device capturing issue	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Device connection issue	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0012 events2 affected160 at risk
Device dislocation	General disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected318 at risk EG00110 events7 affected160 at risk
Device electrical impedance issue	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Device lead damage	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Device misuse	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Device pacing issue	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Device psychogenic complication	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Device stimulation issue	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0012 events2 affected160 at risk
Hernia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Implant site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0011 events1 affected160 at risk
Implant site pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Multi-organ failure	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0012 events2 affected160 at risk
Polyp	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Sudden cardiac death	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0011 events1 affected160 at risk
Undersensing	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Anal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Bacterial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0011 events1 affected160 at risk
Bronchopneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0013 events3 affected160 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Device related infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Empyema	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Implant site infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0014 events4 affected160 at risk
Infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0012 events2 affected160 at risk
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Liver abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Parotitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pelvic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00019 events16 affected318 at risk EG00112 events9 affected160 at risk
Postoperative wound infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0012 events1 affected160 at risk
Respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 events7 affected318 at risk EG0012 events2 affected160 at risk
Septic shock	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Staphylococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0014 events4 affected160 at risk
Urosepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0011 events1 affected160 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pocket erosion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Blood bilirubin abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Clostridium test positive	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected318 at risk EG0010 events0 affected160 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0012 events2 affected160 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0013 events3 affected160 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0011 events1 affected160 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0013 events3 affected160 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0013 events3 affected160 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0012 events2 affected160 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected318 at risk EG0011 events1 affected160 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0012 events1 affected160 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0012 events2 affected160 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Metastases to gastrointestinal tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cerebral infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0012 events2 affected160 at risk
Cervical root pain	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Dementia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Nerve compression	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Presyncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0012 events1 affected160 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected318 at risk EG0010 events0 affected160 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected318 at risk EG0012 events2 affected160 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0009 events8 affected318 at risk EG0016 events6 affected160 at risk
Renal impairment	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected318 at risk EG0010 events0 affected160 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 events5 affected318 at risk EG00111 events6 affected160 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0012 events2 affected160 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Bladder neoplasm surgery	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Heart transplant	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected318 at risk EG0010 events0 affected160 at risk
Aortic aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Aortic stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0011 events1 affected160 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Arterial stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected318 at risk EG0010 events0 affected160 at risk
Embolism	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Haematoma	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Hypertensive crisis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Hypertensive emergency	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected318 at risk EG0012 events2 affected160 at risk
Intermittent claudication	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected318 at risk EG0010 events0 affected160 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected318 at risk EG0010 events0 affected160 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected318 at risk EG0010 events0 affected160 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected318 at risk EG0011 events1 affected160 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases