REsynchronization reVErses Remodeling in Systolic Left vE... | NCT00271154

Label	Type	Description	Intervention Names
CRT OFF	Placebo Comparator	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
CRT ON	Active Comparator	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy	Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT	Device	All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.

Measure	Description	Time Frame
Percentage of Patients Worsened for Clinical Composite Response	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 HF symptoms compared to before CRT implant.	12 Months

Measure	Description	Time Frame
Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)	The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.

Name	Affiliation	Role
Cecilia Linde, MD, PhD	Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
19038680	Result	Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.
18401214

ID	Title	Description
FG000	CRT OFF	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
FG001	CRT ON	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure acute	General disorders	MedDRA	Systematic Assessment	EG00052 events30 affected191 at risk EG00198 events56 affected419 at risk EG0025 events2 affected38 at risk
Medical device change	General disorders	MedDRA	Systematic Assessment	EG00019 events19 affected191 at risk EG00146 events45 affected419 at risk EG0021 events1 affected38 at risk
Ventricular tachycardia	General disorders	MedDRA	Systematic Assessment	EG00014 events11 affected191 at risk EG00143 events30 affected419 at risk EG0021 events1 affected38 at risk
LV lead dislodgement	General disorders	MedDRA	Systematic Assessment	EG00015 events13 affected191 at risk EG00128 events26 affected419 at risk EG0022 events2 affected38 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected191 at risk EG00125 events21 affected419 at risk EG0020 events0 affected38 at risk
Pneumonia	General disorders	MedDRA	Systematic Assessment	EG0009 events8 affected191 at risk EG00119 events16 affected419 at risk EG0021 events1 affected38 at risk
Atrial fibrillation	General disorders	MedDRA	Systematic Assessment	EG0008 events8 affected191 at risk EG00119 events15 affected419 at risk EG0020 events0 affected38 at risk
Device lead damage	General disorders	MedDRA	Systematic Assessment	EG0008 events8 affected191 at risk EG00118 events18 affected419 at risk EG0020 events0 affected38 at risk
Inappropriate device therapy	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected191 at risk EG00116 events16 affected419 at risk EG0020 events0 affected38 at risk
Ventricular fibrillation	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected191 at risk EG00111 events8 affected419 at risk EG0021 events1 affected38 at risk
Cardiac failure chronic	General disorders	MedDRA	Systematic Assessment	EG0006 events5 affected191 at risk EG0016 events5 affected419 at risk EG0022 events2 affected38 at risk
Chronic obstructive pulmonary disease	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected191 at risk EG00111 events7 affected419 at risk EG0020 events0 affected38 at risk
RV lead dislodgement	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG00113 events13 affected419 at risk EG0020 events0 affected38 at risk
Syncope	General disorders	MedDRA	Systematic Assessment	EG0007 events5 affected191 at risk EG0015 events5 affected419 at risk EG0021 events1 affected38 at risk
Angina pectoris	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected191 at risk EG0018 events8 affected419 at risk EG0020 events0 affected38 at risk
Atrial flutter	General disorders	MedDRA	Systematic Assessment	EG0006 events6 affected191 at risk EG0015 events4 affected419 at risk EG0021 events1 affected38 at risk
Inappropriate device irritation of tissue	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected191 at risk EG0019 events9 affected419 at risk EG0020 events0 affected38 at risk
Cerebrovascular accident	General disorders	MedDRA	Systematic Assessment	EG0005 events4 affected191 at risk EG0016 events5 affected419 at risk EG0020 events0 affected38 at risk
Gastrointestinal hemorrhage	General disorders	MedDRA	Systematic Assessment	EG0006 events6 affected191 at risk EG0015 events4 affected419 at risk EG0020 events0 affected38 at risk
Hypotension	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0019 events9 affected419 at risk EG0021 events1 affected38 at risk
Dyspnea	General disorders	MedDRA	Systematic Assessment	EG0003 events2 affected191 at risk EG0017 events7 affected419 at risk EG0020 events0 affected38 at risk
Failure to capture	General disorders	MedDRA	Systematic Assessment	EG0006 events5 affected191 at risk EG0014 events4 affected419 at risk EG0020 events0 affected38 at risk
Lead dislodgement	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG00110 events8 affected419 at risk EG0020 events0 affected38 at risk
RA lead dislodgement	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0018 events8 affected419 at risk EG0020 events0 affected38 at risk
Renal failure acute	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected191 at risk EG0016 events6 affected419 at risk EG0020 events0 affected38 at risk
Transient ischemic attack	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0018 events8 affected419 at risk EG0020 events0 affected38 at risk
Coronary artery disease	General disorders	MedDRA	Systematic Assessment	EG0005 events4 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Carotid artery stenosis	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0015 events5 affected419 at risk EG0020 events0 affected38 at risk
Implant site hematoma	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0016 events6 affected419 at risk EG0020 events0 affected38 at risk
Myocardial infarction	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected191 at risk EG0014 events4 affected419 at risk EG0020 events0 affected38 at risk
Osteoarthritis	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0015 events5 affected419 at risk EG0020 events0 affected38 at risk
Pneumothorax	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0016 events5 affected419 at risk EG0020 events0 affected38 at risk
Acute myocardial infarction	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0014 events4 affected419 at risk EG0020 events0 affected38 at risk
Atrial tachycardia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0013 events3 affected419 at risk EG0021 events1 affected38 at risk
Ischemic stroke	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0015 events3 affected419 at risk EG0020 events0 affected38 at risk
Pericardial effusion	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Peripheral vascular disorder	General disorders	MedDRA	Systematic Assessment	EG0003 events1 affected191 at risk EG0011 events1 affected419 at risk EG0021 events1 affected38 at risk
Renal failure	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Acute pulmonary edema	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0021 events1 affected38 at risk
Anemia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0014 events4 affected419 at risk EG0020 events0 affected38 at risk
Asthma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events2 affected419 at risk EG0021 events1 affected38 at risk
Atrioventricular block complete	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0023 events3 affected38 at risk
Bradycardia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Bronchitis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0014 events3 affected419 at risk EG0020 events0 affected38 at risk
Cardiac arrest	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Cholecystitis acute	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Deep vein thrombosis	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Implant site infection	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0012 events1 affected419 at risk EG0020 events0 affected38 at risk
Inappropriate device signal detection	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Ischemic cardiomyopathy	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0021 events1 affected38 at risk
Lung neoplasm malignant	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Respiratory failure	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Acute respiratory failure	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Angina unstable	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Aortic aneurysm	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Atrioventricular block third degree	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Back pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Bronchitis acute	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Cardiac perforation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0021 events1 affected38 at risk
Cardiac tamponade	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0021 events1 affected38 at risk
Contusion	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0021 events1 affected38 at risk
Defibrillation threshold increased	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Dehydration	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Dizziness	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events2 affected419 at risk EG0020 events0 affected38 at risk
Esophageal carcinoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Hematoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Intracardiac thrombus	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Myocardial ischemia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Pericarditis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events2 affected419 at risk EG0020 events0 affected38 at risk
Presyncope	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Prostate examination abnormal	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0013 events3 affected419 at risk EG0020 events0 affected38 at risk
Pulmonary edema	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Subclavian vein thrombosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Therapeutic agent toxicity	General disorders	MedDRA	Systematic Assessment	EG0002 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Anxiety	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0021 events1 affected38 at risk
Aortic stenosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arrhythmia supraventricular	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Arteriovenous fistula	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0021 events1 affected38 at risk
Biliary colic	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cholecystitis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cholelithiasis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Coronary artery dissection	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Coronary artery stenosis	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Diabetes mellitus	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Diabetes mellitus inadequate control	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Drug hypersensitivity	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Drug toxicity	General disorders	MedDRA	Systematic Assessment	EG0002 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Dyspnea exertional	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Electromechanical dissociation	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0021 events1 affected38 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Heart transplant	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hyperglycemia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Inappropriate device stimulation of tissue	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Mental status changes	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Mitral valve incompetence	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events1 affected419 at risk EG0020 events0 affected38 at risk
Orthostatic hypotension	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Oversensing	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Paraesthesia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Pneumonia aspiration	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Postoperative wound infection	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Pulmonary embolism	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events1 affected419 at risk EG0020 events0 affected38 at risk
Pulmonary fibrosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events1 affected419 at risk EG0020 events0 affected38 at risk
Sepsis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Syncope vasovagal	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Tachycardia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Urinary tract infection	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0012 events2 affected419 at risk EG0020 events0 affected38 at risk
Abdominal abscess	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Abdominal discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Abdominal pain upper	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Acute coronary syndrome	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Adverse drug reaction	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Ankle fracture	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Anorexia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Anxiety disorder	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Aortic thrombosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arrhythmia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arterial disorder	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arterial stenosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arteriogram coronary	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arteriopathic disease	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Arthralgia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Bacteraemia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Balance disorder	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Biopsy liver	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Bronchopulmonary aspergillosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cardiac ablation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cardiac failure	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cardiac procedure complication	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Cardio-renal syndrome	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cardiomyopathy	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cardiomyopathy alcoholic	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cellulitis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Cervical dysplasia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Colon cancer	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Colonic obstruction	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Colostomy	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Constipation	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Contrast media reaction	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Convulsion	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Coronary artery restenosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Decreased RV Sensing	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Depressed level of consciousness	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Device electrical finding	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Device migration	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Device related infection	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Diabetes mellitus insulin-dependent	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Dislodgement of LV lead	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Diverticulitis esophageal	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Duodenal ulcer	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Edema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Elevated pacing threshold	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Endocarditis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Epistaxis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Extrasystoles	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Fluid overload	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Gastroenteritis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Goiter	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Hairy cell leukemia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Headache	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hematoma evacuation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hemianopsia homonymous	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Hemoglobin decreased	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Hemorrhage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hemorrhoids	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hepatic function abnormal	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hip arthroplasty	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hypersensitivity	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hyperthyroidism	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hypervolemic	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hypoglycemia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hypokalemia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Hyponatremia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hypothyroidism	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Hypoxia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Implant site erosion	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Implant site inflammation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Implant site irritation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
In-stent arterial restenosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Incision site complication	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Infection	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Inguinal hernia repair	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Intermittent claudication	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Intestinal obstruction	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Iodine allergy	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Joint dislocation	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Joint swelling	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Knee arthroplasty	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Leukothrombopenia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0010 events0 affected419 at risk EG0021 events1 affected38 at risk
Low cardiac output syndrome	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Lower respiratory tract infection	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Lower respiratory tract infection viral	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Lumbar spinal stenosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Lung adenocarcinoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Lung consolidation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Medical device complication	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Melaena	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Metastases to bone	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Metastatic neoplasm	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Mitral valve disease	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Mitral valve repair	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Musculoskeletal chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Neoplasm malignant	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Nephrolithiasis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Nodal arrhythmia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Orthostatic intolerance	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Oxygen saturation decreased	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Palpitations	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Perianal abscess	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Peripheral arterial occlusive disease	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0010 events0 affected419 at risk EG0021 events1 affected38 at risk
Peripheral ischemia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Phlebitis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Pituitary tumor	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Pleural effusion	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Polyneuropathy	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Prostate cancer	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Pulmonary hypertension	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Pulmonary mass	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Rectal hemorrhage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Renal cancer metastatic	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Renal impairment	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Retinal detachment	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Retroperitoneal hemorrhage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Sinusitis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Sinusitis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Skin irritation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Skin ulcer	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Small cell lung cancer stage unspecified	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Small intestinal obstruction	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Spondylolysis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Squamous cell carcinoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Subarachnoid hemorrhage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Subdural hematoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Supraventricular tachycardia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Throat lesion	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Thrombocytopenia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Tonsillar disorder	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Tooth disorder	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Twiddler's syndrome	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Urinary bladder adenoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Valvuloplasty cardiac	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Vascular pseudoaneurysm	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Venous stenosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Ventricular arrhythmia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Ventricular assist device insertion	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Vertigo CNS origin	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Vestibular neuronitis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Viral infection	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected191 at risk EG0010 events0 affected419 at risk EG0020 events0 affected38 at risk
Vocal cord polyp	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Vocal cord thickening	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk
Wound dehiscence	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected191 at risk EG0011 events1 affected419 at risk EG0020 events0 affected38 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D004567	Electrodes, Implanted
D019736	Prostheses and Implants

ID	Title	Description
BG000	CRT OFF	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
BG001	CRT ON	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CRT OFF	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	122	191	61	119
EG001	CRT ON	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy	268	419	140	491
EG002	Not Randomized	These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.	13	38	2	38

ID	Term
D058406	Cardiac Resynchronization Therapy
D017147	Defibrillators, Implantable