Post-Myocardial Infarction Remodeling Prevention Therapy | NCT01213251

Label	Type	Intervention Names
Single Site Pacing	Experimental	Device: Single Site Pacing
Dual Site Pacing	Experimental	Device: Dual Site Pacing
Control	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Single Site Pacing	Device	Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.	Single Site Pacing

Measure	Description	Time Frame
Change in Left Ventricular End Diastolic Volume (LVEDV)	Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.	Baseline - 18 Month Follow Up Visit

Measure	Description	Time Frame
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events	Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myocardial Infarction (MI) within the past 10 days
Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L)
At least 18 years old
Willing to comply with the protocol

Exclusion Criteria:

Documented MI greater than 10 days
Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less than 30 milliliters/minute/1.73 square meter
Life expectancy less than 18 months, as determined by a physician
Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device
QRS duration greater than 120 milliseconds (ms)
Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure planned
Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia
Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is terminated electrically or pharmacologically
Permanent AF that is non self terminating, with cardioversion failed or not attempted within the past year
New York Heart Association (NYHA) Class IV
Non-ischemic cardiomyopathy
Pregnant or planning to become pregnant during the study
Enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from Medtronic, documenting that there is not a concern that co-enrollment could confound the results of this trial.
Breast feeding
Of a vulnerable population as determined by local law or requirement, or a physician

Name	Affiliation	Role
Gregg Stone, MD	Columbia University	Principal Investigator
Angel Leon, MD	Emory University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Arrhythmia Consultants		Scottsdale	Arizona	85251	United States
Kaiser Permanente

PubMed Identifier	Type	Citation	Retractions
26321236	Derived	Stone GW, Chung ES, Stancak B, Svendsen JH, Fischer TM, Kueffer F, Ryan T, Bax J, Leon A; PRomPT Trial Investigators. Peri-infarct zone pacing to prevent adverse left ventricular remodelling in patients with large myocardial infarction. Eur Heart J. 2016 Feb 1;37(5):484-93. doi: 10.1093/eurheartj/ehv436. Epub 2015 Aug 30.

Label	URL
The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale	View source

ID	Title	Description
FG000	Single Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
FG001	Dual Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.

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
	BG00059± 10 BG00160± 12 BG00254± 11 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012 BG0019 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0000 BG0011 BG002

BMI (kg/m^2)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00028± 6 BG00130± 5 BG002

Systolic Blood Pressure (mmHg)

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG000114± 16 BG001118± 21 BG002

Diastolic Blood Pressure (mmHg)

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG00073± 11 BG00171± 12 BG002

Heart Rate from Physical Exam (BPM)

Mean

Standard Deviation

BPM

Title

Denominators

Categories

Title	Measurements
	BG00080± 15 BG00180± 13 BG002

Left Ventricular Ejection Fraction (LVEF)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00043± 9 BG00143± 10 BG002

Left Ventricular End Diastolic Volume (LVEDV)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000107± 25 BG001107± 31 BG002

Left Ventricular End Systolic Volume (LVESV)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00062± 23 BG00162± 22 BG002

QRS Width (msec)

Mean

Standard Deviation

msec

Title

Denominators

Categories

Title	Measurements
	BG00094± 17 BG00197± 17 BG002

NYHA

The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG0009 BG001

Minnesota Living with Heart Failure Questionnaire (MLWHF)

Minnesota Living with Heart Failure Questionnaire (MLWHF) is a health-related quality of life questionnaire. The scale ranges from 0 to 105. In particular, the lower the score the better is the patient's quality of life.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00021± 25 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Left Ventricular End Diastolic Volume (LVEDV)

Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.

Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.

The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.

Posted

Mean

95% Confidence Interval

Baseline - 18 Month Follow Up Visit

ID	Title	Description
OG000	Pooled Pacing	Subjects successfully implanted with a CRT-D device (either single or dual pacing).
OG001	Control	Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.

Units	Counts
Participants	OG00064 OG00134

Title

Denominators

Categories

Title	Measurements
	OG00016.4(8.9 to 23.9) OG00115.8(5.5 to 26.2)

Secondary

Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events

Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.

Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.

Posted

Number

95% Confidence Interval

survival probability

18 months post-implant

ID	Title	Description
OG000	Single Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
OG001	Dual Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.

Units	Counts
Participants

Secondary

Frequency of Hospitalization for Cardiovascular Events

Number of hospitalizations related to cardiovascular events.

Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.

Posted

Number

participants

Baseline - 18 Month Follow Up Visit

ID	Title	Description
OG000	Single Site Pacing	Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
OG001	Dual Site Pacing	Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
OG002	Control	Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.

Units	Counts
Participants

Secondary

Change in New York Heart Association (NYHA) Functional Class

NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change".

Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.

Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.

Posted

Number

participants

Baseline - 18 Month Follow Up Visit

ID	Title	Description
OG000	Pooled Pacing	Subjects successfully implanted with a CRT-D device (either single or dual pacing).
OG001	Control	Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.

Secondary

Change in 6-minute Walk Test Distance

Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.

Change is defined as month 18 minus baseline.

Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.

Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.

Posted

Mean

95% Confidence Interval

meters

1 Month - 18 Month Follow Up Visit

ID	Title	Description
OG000	Pooled Pacing	Subjects successfully implanted with a CRT-D device (either single or dual pacing).
OG001	Control	Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.

Units	Counts
Participants	OG000

Secondary

Change in Quality of Life

Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.

Change is defined as month 18 minus baseline.

Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.

Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline - 18 Month Follow Up Visit

ID	Title	Description
OG000	Pooled Pacing	Subjects successfully implanted with a CRT-D device (either single or dual pacing).
OG001	Control	Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.

Units	Counts
Participants

Secondary

Incidence of Sudden Cardiac Death and Total Mortality

Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.

Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.

Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.

Posted

Number

95% Confidence Interval

percentage of subjects at risk

18 Months post-randomization

ID	Title	Description
OG000	Pooled Pacing	Subjects successfully implanted with a CRT-D device (either single or dual pacing).
OG001	Control	Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.

Units	Counts
Participants	OG000

Secondary

Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.

Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.

Variables resulting in statistical significant (p<0.05) are reported.

All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.

Posted

Mean

Standard Error

regression coefficient

Baseline - 18 Month Follow Up Visit

ID	Title	Description
OG000	All Subjects	All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	EG0002 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0025 events3 affected45 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0012 events1 affected41 at risk EG0025 events3 affected45 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0021 events1 affected45 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0017 events3 affected41 at risk EG0021 events1 affected45 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0012 events1 affected41 at risk EG0020 events0 affected45 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0026 events4 affected45 at risk
Cardiac perforation	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0011 events1 affected41 at risk EG0021 events1 affected45 at risk
Decompensated Heart Failure	Cardiac disorders	MedDRA 18.0	EG0004 events2 affected40 at risk EG00113 events5 affected41 at risk EG0026 events6 affected45 at risk
Dresslers syndrome	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0021 events1 affected45 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0022 events1 affected45 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Chest pain	General disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0011 events1 affected41 at risk EG0022 events2 affected45 at risk
Device infusion issue	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Device stimulation issue	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Implant site haemorrhage	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Lead dislodgement	General disorders	MedDRA 18.0	EG0003 events2 affected40 at risk EG0014 events4 affected41 at risk EG0020 events0 affected45 at risk
Multi-organ failure	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0024 events4 affected45 at risk
Undersensing	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Appendicitis	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Diverticulitis	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Erysipelas	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Implant site infection	Infections and infestations	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Incision site infection	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0026 events3 affected45 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Viral myocarditis	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0022 events2 affected45 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
International normalised ratio increased	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Syncope	Nervous system disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Depression suicidal	Psychiatric disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0003 events2 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Aortic aneurysm	Vascular disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Arterial stenosis	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0012 events2 affected41 at risk EG0021 events1 affected45 at risk
Arterial thrombosis	Vascular disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Hypotension	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Subclavian steal syndrome	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Thrombosis	Vascular disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0011 events1 affected41 at risk EG0022 events2 affected45 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Cardiomegaly	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0021 events1 affected45 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Decompensated Heart Failure	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0013 events3 affected41 at risk EG0025 events4 affected45 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0013 events3 affected41 at risk EG0021 events1 affected45 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0011 events1 affected41 at risk EG0021 events1 affected45 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Hypogonadism	Endocrine disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Keratitis	Eye disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Dental discomfort	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Adverse drug reaction	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0013 events3 affected41 at risk EG0020 events0 affected45 at risk
Chest pain	General disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0013 events3 affected41 at risk EG0022 events2 affected45 at risk
Device alarm issue	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Device capturing issue	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Device electrical impedance issue	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Device infusion issue	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Device malfunction	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Device occlusion	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0013 events1 affected41 at risk EG0020 events0 affected45 at risk
Device pacing issue	General disorders	MedDRA 18.0	EG0004 events4 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Device stimulation issue	General disorders	MedDRA 18.0	EG00013 events8 affected40 at risk EG0014 events4 affected41 at risk EG0020 events0 affected45 at risk
Fatigue	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0021 events1 affected45 at risk
Implant site bruising	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Implant site oedema	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Implant site pain	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Implant site scar	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Implant site swelling	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Lead dislodgement	General disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Medical device pain	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0022 events2 affected45 at risk
Oedema peripheral	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Oversensing	General disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Peripheral swelling	General disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Phantom shocks	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0012 events2 affected41 at risk EG0020 events0 affected45 at risk
Undersensing	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Vessel puncture site haematoma	General disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Acarodermatitis	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	EG0002 events2 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Diverticulitis	Infections and infestations	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Echinococciasis	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Impetigo	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Implant site infection	Infections and infestations	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Influenza	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Cardiac vein dissection	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0012 events2 affected41 at risk EG0020 events0 affected45 at risk
Cardiac vein perforation	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	EG0002 events2 affected40 at risk EG0010 events0 affected41 at risk EG0022 events2 affected45 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Biopsy skin	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Blood pressure increased	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Blood urine present	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Body temperature increased	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
C-reactive protein increased	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Echocardiogram abnormal	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Hepatic enzyme increased	Investigations	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
International normalised ratio increased	Investigations	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0022 events1 affected45 at risk
Liver function test abnormal	Investigations	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0013 events3 affected41 at risk EG0020 events0 affected45 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0022 events2 affected45 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0022 events2 affected45 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Renal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	EG0002 events2 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Headache	Nervous system disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Sciatica	Nervous system disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Syncope	Nervous system disorders	MedDRA 18.0	EG0003 events3 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Acute stress disorder	Psychiatric disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Stress	Psychiatric disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0014 events4 affected41 at risk EG0023 events3 affected45 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 18.0	EG0002 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Hypertension	Vascular disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0011 events1 affected41 at risk EG0020 events0 affected45 at risk
Hypotension	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0011 events1 affected41 at risk EG0023 events3 affected45 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 18.0	EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected45 at risk
Venous stenosis	Vascular disorders	MedDRA 18.0	EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected45 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	Single Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
BG001	Dual Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
BG002	Control	Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Single Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.	22	40	20	40
EG001	Dual Site Pacing	Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.	24	41	25	41
EG002	Control	Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.	20	45	27	45